Axle Informatics

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Job Locations US-MD-Bethesda
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).   Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Clinical Advisor to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID).   Technical Requirements: - Lead the creation and implementation of an overall operational plan for one or more COVID-19 treatment studies, including timeline, key milestones, resources needed and budget. The ACTIV 2 study is the U.S. Government’s premier effort to develop data on promising therapies for outpatients suffering from COVID-19 disease. The study is a complex platform study, capable of testing multiple investigational products simultaneously. It is an adaptive design spanning traditional phase 2 and phase 3 of clinical development. It is being conducted under the auspices of the NIH, and the NIH-funded AIDS Clinical Trial Group (ACTG). - Assess the operational feasibility and resource considerations of new entrants to the trial. - Working through established contract resource organizations and with the sponsor, networks and company partners: - Create a global site/country strategy Oversee the execution of that strategy including site selection including feasibility, qualification and pre-study assessment. - Oversee site activation including, the provision of investigational product, non-IP clinical supplies and laboratory materials; the completion of required regulatory documentation and the granting of needed systems access. - Coordinate efforts to recruit participants into the trial including global trial and site specific recruitment plans, media and outreach programs and vendor programs. - Oversee the execution of the study monitoring and oversight plan. Ensure site productivity and quality issues are actively managed. - Oversee the executions of the data management plan. Ensure that queries are resolved and database closure occurs on time. - Oversee the study close-out plan. - As needed, review processes (or lead a team that reviews the processes) that relate to or impact any of the above items and work with implementing partners to revise SOPs, process pathways, and implementation plans to effect more efficient or rapid outcomes. - Create and oversee the execution of a study risk management plan. Proactively resolve risks to operational delivery. - Lead team meetings. - Support meeting documentation and follow-up action items. - Facilitate reporting of study status to key stakeholders in NIH, Operation Warp Speed, and the ACTG Specific Qualifications: - S./B.A. degree in a related field. - Minimum of ten (10) years of related experience. Benefits - 100% Medical, Dental & Vision premium coverage for Employees - Paid Time Off (Including Holidays) - Employee Referral Bonus - 401K Match - Tuition reimbursement and professional development opportunities - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program (DCAP) - Transportation Reimbursement Account (TRN) The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.   Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com    Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required.
ID
2022-2533
Job Locations US-MD-Bethesda
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).   Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Scientific Program Manager to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID).   Technical Requirements: - Participate in monthly calls on the Malaria L9LS study to review the progress. - Review the protocol prior to scientific review of the Malaria L9LS study. - Develop regulatory strategies appropriate for manufacturing clinical products for Phase I, II, and III trials, e.g., planning, reviewing, and overseeing manufacturing methods, toxicology protocols, and preclinical packages. - Make recommendations regarding alternative serotypes for adenoviral vector vaccine candidates, and assessments of direct viral load and viral immunology studies in concert with VRC researchers. - Responsible for chemistry, manufacturing, and controls (CMC) of all investigational new drug (IND) applications for vaccines and related products and oversee the planning, preparation, and review of IND materials to ensure compliance with FDA guidelines and the Code of Federal Regulations (CFR). - Provide expertise for testing and characterizing strategies for cell substrates, vaccine constructs, and vaccine formulation. - Responsible for assembling all CMC IND packages for integration and submission to regulatory authorities by other intramural or extramural agencies. Specific Qualifications: - Bachelor’s degree with seven (7) to ten (10) years of related experience OR Master’s degree with five (5) to seven (7) years of related experience is required. - Project management skills and ability to synthesize project workloads is required. Benefits - 100% Medical, Dental & Vision premium coverage for Employees - Paid Time Off (Including Holidays) - Employee Referral Bonus - 401K Match - Tuition reimbursement and professional development opportunities - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program (DCAP) - Transportation Reimbursement Account (TRN) The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.   Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com    Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required.
ID
2022-2532
Job Locations US-MD-Rockville
We are seeking a Budget Analyst to join the team at Axle Informatics. The selected candidate will be responding to NIH budgetary requests, preparing reports, forecasts, and analyses for NIH customers as well tracking contract metrics including Earned Value Management. Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH). Responsibilities - Provides financial management over the NIH contract, subcontracts and program to control costs, schedule and performance of the prime contract. - Provides contract-level financial forecasting to include monthly, quarterly, and annual cost projections and scenario modeling to assess project changes. - Provides the centralized planning, direction, and control required to meet the cost, schedule, and performance goals throughout the life-cycle of the contract. - Review of all subcontract & consulting agreements to ensure financial compliance with company policies and federal, state, and local laws.  - Ensures assigned contracts are following and in compliance with Federal Acquisition Regulations, laws, standards, procedures.  - Proposes ways in which financial planning can be improved and/or processes can be streamlined.  Qualifications - 1-2 years of experience with General Budgeting MS Excel, MS Suite, Business Intelligence, Software Experience with earned value cost accounting and reporting. - Experience with metrics for assessing, analyzing, and reporting program cost variances and corrective actions. - Experience managing Time and Materials (T&M), Cost-plus-fixed-fee (CPFF), Cost-plus award Fee (CPAF) or Firm Fixed-Price (FFP) contract types - Proficient with developing program/project plans specifying goals, staffing, scheduling, identification of risks, contingency plans and, allocation of available resources.     Benefits  - 100% Medical, Dental & Vision premium coverage for Employees   - Paid Time Off (Including Holidays)  - Employee Referral Bonus   - 401K Match  - Tuition reimbursement and professional development opportunities  - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program (DCAP) - Transportation Reimbursement Account (TRN)   The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.   Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com   Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.  
ID
2022-2530
Job Locations US-MD-Rockville
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH)   Overview We are seeking an experienced Program Support Specialist to join our Team in North Bethesda, MD Responsibilities - Interfaces with employees and Government clients on a regular basis - Provides programmatic support for on and off-site staff within various federal agencies - Serves as primary point of contact for onsite and offsite employees and develops new or modified procedures to improve effectiveness and efficiency of onsite/offsite operations - Effectively communicates client’s goals and objectives through oral and written communications - Screens and prepares prospective employees for oral presentations; leads and facilitates meetings - Participates fully in the management and development of activities and serves as a critical link between onsite and offsite administrative issues, policies and program management - Communicates program changes, policies and procedures to internal and external stakeholders orally and in writing - Responsible for onboarding onsite and offsite employees including badging, credentialing process and allocation of other onsite and offsite resources - Develops and maintains both program and technical documentation - Coordinates employee travel by preparing travel orders and certifying expense reports - Coordinates annual performance reviews for onsite and offsite staff; addresses and resolves performance issues - Establishes and maintains cooperative working relationships with a diverse group of staff members, stakeholders, and customers to support successful performance across project operations - Ability to take on ownership, modernize solutions, and manage conflicting priorities with minimal guidance - Ability to prioritize and provide precise follow-ups on all issues and communications Qualifications: - Bachelor’s degree with a minimum 3 years of experience providing program management support and assistance within an organization, preferably federal agencies - Previous NIH experience is highly desired - Ability to manage operational logistics and multiple service requests simultaneously - Exceptional communication skills demonstrated through written materials and oral presentations - Proficient in Microsoft Office suite, (specifically Word, Excel, and PowerPoint) - Skilled in facilitating teams and coordinating efforts for the successful achievement of goals - Exceptional problem-solving, critical thinking and organizational skills required Benefits - 100% Medical Dental & Vision Coverage for Employees​ - Educational Benefits for Career Growth​ - Paid Time Off (Including Holidays) ​ - Employee Referral Bonus ​ - Profit Sharing - 401K Matching​ - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program (DCAP) - Transportation Reimbursement Account (TRN)   The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.   Accessibility: If you need an accommodation as part of the employment process please contact careers@axleinfo.com.   Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
ID
2022-2529
Job Locations US-MD-Bethesda
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).   Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Scientific Program Manager to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID).   NOTE : 100% remote work will not be an option once we return to the office.   Technical Requirements: - Work with federal staff responsible for cGMP product development of vaccines for infectious diseases including the production of investigational products that are identified as strong candidates to move from a preclinical to clinical phase. - Plan, organize, and coordinate cGMP activities across all project stakeholders. Set deadlines, record responsibilities, and monitor and summarize progress of various cGMP manufacturing projects. - Participate as a team member in a group composed of different staffing areas including scientific/technical roles, project management, regulatory affairs, quality assurance, contracts, and finance. Activities include, participating in both the development of vaccines and adjuvants, assisting in the authoring the Chemistry, Manufacturing and Controls and Toxicology sections of Investigational New Drug submissions, providing protocol and Investigator Brochure review, and assisting in providing oversight of Contract Manufacturing Organizations. - Coordinate with Quality, Regulatory, and Technical team members for health regulatory compliance. - Assist the team with impact/risk assessment from issues, failures and deviations during manufacturing and pre-clinical studies. - Develop, coordinate, and monitor business agreements to include MTAs, CRADAs, DTAs, and other agreements as necessary. - Prepare technical reports, updates, and summaries for internal meetings with Division Management. - Participate in site visits of CMOs at kick-off or during critical project execution stages or for troubleshooting as requested by the POC. - Maintain an organized, efficient, and accessible electronic document filing system. This includes historical, current, and projected information on proposals, presentations, business agreements, grant awards, cGMP projects, and other Branch activities. - Review, GMP manufacturing batch records, SOPS, deviation reports, etc. - Participate with Team members to track product stability reports with respect to stability timepoints, review the product stability protocol for consistency and completeness, ensure that the stability program matches the requirement per the project Statement of Work, review stability Certificate of Analysis and/or Stability reports/data for out of specification testing results, issue the Shelf Life Extension document after reviewing of the stability report. - Assist in the preparation and review of regulatory documents including pre-IND materials, and IND, as required. - Prepare oral and written presentations for internal and external programmatic and scientific meetings. - Participate in virtual and on-site audits of vendors. Specific Qualifications: - S. degree in biochemistry or biology or equivalent education and at least 8 years of experience in industry, or B.S. degree in biochemistry or biology or equivalent education and at least 10 years of experience in industry. - PMP certification and experience in managing cGMP of biologics is preferred. Benefits - 100% Medical, Dental & Vision premium coverage for Employees - Paid Time Off (Including Holidays) - Employee Referral Bonus - 401K Match - Tuition reimbursement and professional development opportunities - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program (DCAP) - Transportation Reimbursement Account (TRN) The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.   Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com   Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required.
ID
2022-2528
Job Locations US-MD-Bethesda
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).   Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Biologist to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID).   Technical Requirements: - Utilize various laboratory equipment such as Biological Safety Cabinet (BSC), centrifuge, pipettes, liquid nitrogen tank, and others. - Work with dry ice, freezers, and liquid nitrogen tanks to store clinical samples, while always wearing appropriate PPE. - Place and remove specimens from appropriate biorepository freezers. - Accept and sign chain of custody requests for clinical samples sent to and from the NIH Clinic and extramural collaborators following regulatory and protocol requirements. - Wear appropriate Personal Protective Equipment (PPE) in a BSL-2 laboratory. - Competence in VIP’s LIMS including entering samples, editing aliquot numbers, creating pull lists, and checking samples out. - Maintain LIMS systems; Monitor the system, ensure LIMS is operational at all times, assist with upgrades, write necessary SOPs for maintenance and preventative maintenance (with QA sign off). - Work collaboratively with team members to complete all tasks for the day, but also be accountable as an individual for personal tasks. - Sustains close and effective communications with VIP management and external collaborators. - Support senior VIP personnel to ensure systems are compliant at all times. - Perform basic equipment maintenance as needed. Specific Qualifications: - BS with 5+ years of experience with 2+ years in a leadership role in a BSL-2 laboratory, processing blood specimens. - IT skills such that candidate knows or can quickly learn to utilize LIMS, EDMS, Microsoft Office, etc. - Strong computer system expertise, from a super-user rather than an IT perspective. - Lab information management systems experience (i.e., Freezerworks). - Knowledge of governing regulations for laboratory-based computer systems. - Excellent technical writing skills and good documentation practices with understanding of standard operating procedures. - Demonstrate ability to multi-task and prioritize projects efficiently, as well as ability to work independently and proactively on various projects. - Detail oriented while performing laboratory tasks. - Follows directions and protocols without deviations. - Demonstrate ability to work in a team setting and to handle high-throughput environment. - Ability to work well with others and independently. Benefits - 100% Medical, Dental & Vision premium coverage for Employees - Paid Time Off (Including Holidays) - Employee Referral Bonus - 401K Match - Tuition reimbursement and professional development opportunities - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program (DCAP) - Transportation Reimbursement Account (TRN) The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.   Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com    Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required.
ID
2022-2527
Job Locations US-MD-Bethesda
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).   Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Bioninformatics Scientist to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID).   Technical Requirements: - Develop and maintain bioinformatics pipelines for various genomics applications. - Develop web-based in-house database interface. - Implement and utilize workflows for next generation sequencing (i.e., QC and analysis). - Participate in innovation and development of analytical solutions. - Work collaboratively with multi-disciplinary team. Specific Qualifications: - BA/BSc with 6+ years of experience or MA/MSc with 4+ years of experience - Experience must be from a related field (i.e., Bioinformatics, Molecular Biology, Computer Science, or related discipline) - Programming experience using relevant packages (i.e., Python, Perl, R) - Detailed understanding of Illumina based NGS methods and tools - Experience troubleshooting and exploring various existing scientific analysis tools - HPC clusters and use of command line tools and scripting experience - Working knowledge of existing tools to analyze NGS data - Experience with relational database design and maintenance (i.e., MySQL, Postgres) is a plus Benefits - 100% Medical, Dental & Vision premium coverage for Employees - Paid Time Off (Including Holidays) - Employee Referral Bonus - 401K Match - Tuition reimbursement and professional development opportunities - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program (DCAP) - Transportation Reimbursement Account (TRN) The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.   Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com    Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required.
ID
2022-2525
Job Locations US-MD-Bethesda
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).   Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Lab Technician to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID).   Technical Requirements: - Assist with a wide variety of complex experimental procedures involving microbiology and molecular biology, cell biology, biochemistry, and immunology techniques to perform lab research. Techniques involved will include DNA/RNA purification and quantitation, real-time PCR, gene synthesis, mutagenesis, cloning, bacterial transformation, plaque cloning, maintenance of bacterial stocks, and cell culture. Other areas of expertise in conducting research may include immunological techniques such as ELISAs, western blotting, microscopy, and small animal infection models to evaluate pathogenesis. - Maintain detailed records of experiments and their results. - Collect and organize data, performing data analysis, and preparing technical reports, summaries, protocols, and inventories. - Write report(s) of findings, stating methods and procedures, including any modifications employed, specimens and materials involved, and results of experiments. - Able to perform and operate and communicate effectively in a group, team-oriented working environment. - Willing to learn principles of molecular biology, genetics, systems biology, and immunology. - Perform quality control of the laboratory. - Responsible for laboratory upkeep and routine maintenance of equipment. Maintain laboratory supplies and equipment including chemicals, biological materials, etc. required to handle biological materials, carcinogens, recombinant protein materials, acids, biological wastes, etc. Specific Qualifications: - Bachelor’s degree in biology or related discipline required. - Minimum of 2 years of work experience post bachelor’s degree in a research laboratory setting. - Effective communication skills working in a team atmosphere. - Willingness and ability to work flexible hours when experimental needed. Benefits - 100% Medical, Dental & Vision premium coverage for Employees - Paid Time Off (Including Holidays) - Employee Referral Bonus - 401K Match - Tuition reimbursement and professional development opportunities - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program (DCAP) - Transportation Reimbursement Account (TRN) The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.   Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com   Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required.  
ID
2022-2522
Job Locations US-MD-Bethesda
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).   Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Clinical Research Coordinator to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID).   Technical Requirements: - Devise working plans and standards of practice for the identification, screening, randomization and enrollment of subjects in IRB approved clinical trial protocols at NIAID-sponsored international sites in collaboration with local investigators. - Oversee the implementation all trial related activities according to each individual IRB approved clinical trial protocol, established Standard Operating Procedures (SOPs), sponsor specifications and Good Clinical Practice (GCP). - Build and maintain excellent communication with Principal Investigators and collaborators at international sites in order to conduct high quality clinical trials. - Ensure efficient monitoring of all trials by ensuring that the data is clean and entered accurately into the sponsor EDC in a timely fashion. - Coordinate with international colleagues site initiation activities as well as oversee the setup and maintenance of studies. - Create and submit regulatory and associated documents as needed to start new clinical trials. - Maintain both new and ongoing IRB processes. - Revise IRB submissions in response to identified problems and resolve issues in a timely manner. - Review audit findings from the medical monitor and/or internal auditor and discuss with Principal Investigators when needed. - Prepare reports summarizing clinical and research information obtained for the purpose of communication with the IRB and publication. - Interface with clinical laboratories, contract laboratories, NIH research laboratory personnel and outside laboratories to ensure correct and timely specimen collection and track results of testing. - Track and obtain knowledge to observe and report adverse/serious adverse events, protocol violations/deviations in a timely and accurate manner in collaboration with international colleagues - Attend all clinical operations meetings and conduct strategic planning as needed. Specific Qualifications: - Work location: Fishers Lane Bldg 5625, RM 4N-07D - RN, PA, NP degree or equivalent preferred - Prior experience as study coordinator required - French language skills desirable but not required - Travel to study sites in Mali 2-3 times per year for approximately 5-7 days per trip o Part-time: 30hr/wk. Benefits - 100% Medical, Dental & Vision premium coverage for Employees - Paid Time Off (Including Holidays) - Employee Referral Bonus - 401K Match - Tuition reimbursement and professional development opportunities - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program (DCAP) - Transportation Reimbursement Account (TRN) The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.   Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com   Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required.
ID
2022-2521
Job Locations US-MD-Rockville
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH) Overview We are seeking an experienced Jr. Full Stack Developer to join our Team in North Bethesda, MD. This position has the option to work fully remote.  Responsibilities: - Participate in agile software development, prototyping and code reviews with a small team of developers - As a full-stack developer, you will code back-end services in Java/Go/Node JS and front-end in HTML, CSS3 and JavaScript Angular JS - Design, implement and/or use RESTful web services - Implement modern and responsive UI for the web and variety of devices - Write testable, well thought-out code within the Java ecosystem, embracing additional languages and frameworks when appropriate - Unit, e2e and performance testing software under load to ensure reliability and scalability   Qualifications: - Prior experience working on a scalable web based application. - 2+ years of experience as Full stack developer and/or server-side. - Strong experience with Java in web app development with Scala. - Experience designing, implementing and using RESTful Web Services with Service-Oriented Architecture. - Must have 2+ years of hands-on experience with Angular. - Must have 2+ years of hands-on experience with Node JS. - Must have 2+ years of hands-on experience with Typescript - Must have 2+ years of experience with JavaScript  - 2+ years’ experience programming. - Knowledge and experience with various JavaScript frameworks like React, D3, etc and strong experience working with MVC. - Solid understanding of version control principles, preferably using Git - Experience using mocking frameworks, testing frameworks, dependency injection, NoSQL and/or relational databases - Excellent knowledge on HTML, CSS, and cross-browser layout skills and responsive design knowledge. - Strong knowledge on how to navigate the vast and quickly evolving collection of open source projects and select the right tool for the job - Attention to detail and an ability to build reliable, scalable, and flexible software. - Knowledge and experience with authentication is plus. Benefits: - 100% Medical, Dental & Vision premium coverage for Employees   - Paid Time Off (Including Holidays)   - Employee Referral Bonus   - 401K Match   - Tuitionreimbursement and professional development opportunities  - Flexible Spending Accounts:  - Healthcare (FSA)  - Parking Reimbursement Account (PRK)  - Dependent Care Assistant Program (DCAP)  - Transportation Reimbursement Account (TRN) The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.   Accessibility: If you need an accommodation as part of the employment process please contact:careers@axleinfo.com    Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.    
ID
2022-2520
Job Locations US-MD-Bethesda
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).   Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Project Manager (Budget Analyst) to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID).   Technical Requirements: - Maintain multiyear financial models and work collaboratively to assure that Division financial models are congruent with Institute planning models. - Provide input and assistance in the establishment of an operational budgetary plan for the year of execution. - Provide input and assistance with the preparation of periodic updates of the operational budgetary plan during the year of execution. - Formulate and adapt budget planning models to align with scientific opportunities as defined by Division leadership. - Maintain, update and monitor Division planning and execution data systems and track variances of actual to budget. - Assist with the maintenance of commitment base tracking systems based upon past and current funding allocations. - Provide assistance and tracking on a spectrum of budget-related NIAID/DAIDS activities, including: - Multi-year grants programs - Multi-year contract awards and interagency agreements - Division leadership and Advisory Council approvals - Funds management under continuing resolutions - Managing expenditures on a continuing basis during the End-of-Year process to assure efficient use of budgeted funds - COVID-19 research resource management and spending activities - Budget opportunity pool realignment requests - Assist in the response to budget-related communications requests (press releases, congressional inquiries, etc.) - Generate and provide appropriate financial data for the Institute budget mission plan. - Assist in the preparation of Commitment Bases, Budgets, and Strategic Plan Tables (Preliminary Budget Plan components) as required by the NIH Office of AIDS Research (OAR) each year. - Assist in the preparation and reporting of actual financial results as required by OAR each year.   Specific Qualifications: - Minimum of a Bachelor’s degree with at least 5 years experience working with complex multicomponent budgets. Benefits - 100% Medical, Dental & Vision premium coverage for Employees - Paid Time Off (Including Holidays) - Employee Referral Bonus - 401K Match - Tuition reimbursement and professional development opportunities - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program (DCAP) - Transportation Reimbursement Account (TRN) The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.   Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com   Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required.    
ID
2022-2519
Job Locations US-MT-Hamilton
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).   Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Laboratory Technician to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID).   Technical Requirements: - Perform a wide variety of procedures and techniques which may include, but are not limited to: cell culture, clinical/diagnostic microbiology, DNA analysis, DNA isolation, DNA purification, DNA sequencing, flow cytometry, gene cloning, manipulation of radioactive isotopes, natural product isolation, organic synthesis, peptide synthesis, protein analysis, RNA isolation, etc. - Perform a wide variety of procedures and techniques which may include, but are not limited to: qRT-PCR, germ free mice, RNA and DNA isolation, and cell culture. - Perform general lab management, and responsible for laboratory upkeep and routine maintenance of equipment, maintain laboratory supplies and equipment including chemicals, biological materials, etc., required to handle biological materials, carcinogens, recombinant protein materials, acids, biological wastes, etc., maintain work bench and equipment related to projects. Catalog and label laboratory samples. Help with maintain and organize inventory of samples and metadata, and with managing inventory of laboratory supplies and reagents. Liaise with vendors as needed. - Maintain detailed records of experiments and their results and prepare the information resulting from these experiments for presentations at laboratory-wide meetings and for publication. - Write reports of findings, stating methods and procedures, including any modifications employed, specimens and materials involved and results of experiments. Maintain laboratory records. Interpret, evaluate, and discuss the results of each experiment with the Federal Task Leader as part of the planning process for subsequent studies. - Operate and communicate effectively in a group, team-oriented working environment. Work with and support others in a collegial, open, respectful, and interactive working manner. Work collaboratively with others in the lab to generate data for publications. - Assist in the analysis and interpretation of data and preparing summaries of laboratory findings to be used in reports and papers to be presented at scientific meetings and/or publication in scientific journals. - Willing to learn principles of molecular biology, genetics, systems biology, and immunology. - Perform quality control of the laboratory. - Generate laboratory records to support laboratory research, and independently perform necessary calculations. Specific Qualifications: - Bachelor’s degree in biology or related discipline required - Minimum 1-3 years of work experience - Effective communication skills working in a team atmosphere - Willingness and ability to work flexible hours when experimental needs require it. - Experience with single-cell RNA sequencing, FACS analysis, microbiome analysis and multi-omics data integration. Benefits - 100% Medical, Dental & Vision premium coverage for Employees - Paid Time Off (Including Holidays) - Employee Referral Bonus - 401K Match - Tuition reimbursement and professional development opportunities - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program (DCAP) - Transportation Reimbursement Account (TRN) The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.   Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com   Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required.    
ID
2022-2518
Job Locations US-MD-Bethesda
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).   Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Scientific Reviewer (ARB & IRB) to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID).   Technical Requirements: - Work with the Designated Federal Official (DFO), Federal Scientific Review Officer (SRO), to manage the scientific peer review of grant and cooperative agreement applications, and contract proposals assigned to the NIAID for primary merit review. - Assist the DFO on multiple tasks/review assignments (grants and contracts) at one time. - Possess and apply scientific knowledge in areas related to the NIAID mission and the NIH peer review process. - Possess and apply Federal, DHHS, and NIH grant and contract acquisition policy to all work. - Assist the DFO in identifying the administrative and the scientific issues in the grant applications or contract proposals, e.g., application completeness, adherence to scientific and administrative requirements of the solicitation; understand the hypotheses and rationale presented in the applications/proposals; describe and list the type of science and specific technologies proposed in the application and contract proposals. - Possess the ability to learn how to use the NIH and NIAID developed digital business systems (IMPAC II, eRA Commons, QVR, RIMS, Pub Med, NIH Reviewer Support Site, NIAID SRDMS, SRP Access databases, NIH Reporter, numerous macros) that have been developed to facilitate SRP SROs work. - Able to search for reviewers with appropriate scientific expertise and recommend potential reviewers to the DFO. - Use good writing and communication skills. - Provide timely response to all inquiries from the program, reviewers, and applicants and keeps DFO informed of all actions. - Assist the DFO in preparing guidance documents for reviewers, use of electronic systems, and submission of critiques. - Capture the results of committee deliberations during the review meeting. - Assist the DFO with the conduct of the review meeting. - Assist the DFO in the development of summary statements for grant application reviews, or Technical Evaluation Reports for contract proposals. Specific Qualifications: - Ph.D. in microbiology, immunology, virology, or related biomedical or translational field with expertise and independent research in basic or clinical research background in one or more of the following areas: HIV/AIDS, basic and translational virology, biology and immunology of infectious diseases, microbiology, parasitology, basic and translational immunology, autoimmunity, allergic diseases, transplantation immunology, mucosal immunology, vaccine immunology, and/or immunological effects of radiation exposure. infectious diseases: postdoctoral experience (recent research presentations and publications in peer-reviewed journals are expected as evidence of independent research experience); bachelor’s degree plus four (4) years of specialized experience are equivalent to a Ph.D. or a Minimum of five (5) years of related experience. - Proficiency in Microsoft Office suite (MS Access experience). - Excellent oral and written communications skills. - Some knowledge of NIH. - Organizational and interpersonal abilities; proficiency in technical/scientific writing. - Ability to lift boxed paper files for transport to/from meetings. Benefits - 100% Medical, Dental & Vision premium coverage for Employees - Paid Time Off (Including Holidays) - Employee Referral Bonus - 401K Match - Tuition reimbursement and professional development opportunities - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program (DCAP) - Transportation Reimbursement Account (TRN) The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.   Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com   Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required.
ID
2022-2517
Job Locations US-MD-Rockville
Axle Informatics is a bioinformatics and information technology company that offers innovative computer services, informatics, and enterprise solutions to research centers and healthcare organizations around the globe. With experts in software engineering, bioinformatics and program management, we focus on developing and applying technology tools and techniques to empower decision-making and accelerate the discovery in translational research. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of health (NIH).
ID
2022-2515
Job Locations US-MD-Bethesda
  Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).   Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Biologist (Cell Neutralization Specialist) to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID).   Technical Requirements: - Perform routine cell culture using aseptic techniques, prepare cells for downstream applications, and maintain appropriate documentation for multiple cell line types. - Reverse genetic rescues and pseudo type virus transfection propagations for use in large scale assays. - Prepare laboratory reagents and qualification of reagents as necessary, with appropriate documentation. - Process and work with sera as well as other biologics for use in assays. - Handle liquids in large volumes using serological pipettes, small volumes using single and multichannel pipettes, and utilize automated liquid handling systems. - Adopts optimize, and execute various types of neutralization assays on multiple platforms including automated systems such as the Biomek i7. - Train other analysts to run various assays including any special training needed for protocols in a GCLP environment. - Schedule and perform preventative maintenance on the various laboratory equipment following GCLP requirements. - Follow approved SOPs to complete testing of samples in an organized, aseptic, high-throughput manner. - Uphold rapid turn-around times of specimen samples by effectively managing resources while maintaining high standards of accuracy. - Maintain supplies and reagents for scheduled tests. - Adjust quickly to changes in schedule as priorities, needs and reagents shift. - Follow GCLP guidelines and maintain records. - Wear appropriate Personal Protective Equipment (PPE) in a BSL-2 laboratory. - Work collaboratively with team members to complete all tasks for the day and accountable as an individual for personal tasks. - Properly utilize various laboratory equipment such as Biological Safety Cabinet (BSC), centrifuge, pipettes, liquid nitrogen tank, and others. - Competence in VIP’s LIMS including entering test results on samples. - Work with dry ice, freezers, and liquid nitrogen tanks to store clinical samples, while always wearing appropriate PPE. - Sustain close and effective communications with VIP management and external collaborators. Specific Qualifications: - BS in a related field. - Minimum of 2+ years of experience in a BSL-2 laboratory, prior experience with cell culture and preference for neutralization assays. - Candidate knows or can quickly learn to utilize computer and data management programs such as but not limited to LIMS, CQMS, Microsoft Office, etc. - Ability to work well with others and independently. - Ideal, but not required: experience in a GCLP environment and utilizing Beckman Coulter automated liquid handling software such as SAMI and Biomek. Benefits - 100% Medical, Dental & Vision premium coverage for Employees - Paid Time Off (Including Holidays) - Employee Referral Bonus - 401K Match - Tuition reimbursement and professional development opportunities - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program (DCAP) - Transportation Reimbursement Account (TRN) The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.   Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com    Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required.  
ID
2022-2509
Job Locations US-MD-Bethesda
  Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).   Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Clinical Protocol Coordinator to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID).   Technical Requirements: - Manage Trial Master File program for all CTP studies. Develop protocol-specific TMF indexes and plans at trial start, collect and file TMF documents throughout the trial, correspond with TMF CRO support during and after the trial, and ensure QC of final TMF at the end of the trial. - Advise, coordinate and plan scientific research activities for Phase I and II clinical trials for investigational vaccines and monoclonal antibodies targeting infectious diseases including influenza, HIV, malaria, etc. - Serve as a clinical protocol study team member, will actively engage in protocol planning and development and development and assessment of domestic and international sites. - Develop processes and SOPs and other documents to support TMF management. - Ensure adherence to processes and SOPs specific to documents under their management. - Ensure documents are readily available for audits and inspections. - Participate in internal or external audits and regulatory authority inspections as needed. - Provide guidance and serve as a TMF resource to colleagues. Draft, edit, and review protocols and operations manuals specific to the research projects. - Provide scientific and regulatory guidance and assistance to the program in support of product development. - Serve as a liaison to the VRC Office of Regulatory Science. - Review and provide input on various research agreements (interagency agreements, clinical trial agreements, etc.) to ensure the program’s needs are met. Specific Qualifications: - Master’s degree; a bachelor’s degree with applicable job experience may be considered. Regulatory Affairs Certification (RAC) preferred. - Minimum 5 years of experience in the pharmaceutical/biotechnology industry, government, or equivalent, including minimum 3 years clinical document management system experience, preferably with drugs or biologics products. - Experience participating in internal or external audits and regulatory authority inspections preferred. - Demonstrates knowledge and understanding of GCP, ICH guidelines and, regulatory requirements for clinical research and TMFs. - Ability to work independently and as part of a team. - Strong organizational skills. - Excellent oral and written communication skills. Benefits - 100% Medical, Dental & Vision premium coverage for Employees - Paid Time Off (Including Holidays) - Employee Referral Bonus - 401K Match - Tuition reimbursement and professional development opportunities - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program (DCAP) - Transportation Reimbursement Account (TRN)   The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.   Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com   Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required.  
ID
2022-2508
Job Locations US-MD-Bethesda
  Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).   Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Clinical Advisor to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID).   Technical Requirements: - Serve as an advisor to the TRP Director and Deputy Director on administrative and operational issues. - Collaborate with Program staff to plan and coordinate programmatic activities for TRP high priority science (i.e. HIV and HIV-associated coinfections and comorbidities). - Participate in the review, planning, and implementation of clinical trials under TRP’s purview. - Track all TRP planned and ongoing clinical trials and provides the framework and tools for trial documentation. - Coordinate clinical review activities/meetings for the TRP portfolio, including support for the Clinical Science Review Committee and pre-review activities for the NIAID Data Safety and Monitoring Boards. - Serve as the TRP Liaison to clinical trial-related working groups led by the Office for Policy in Clinical Research Operations (protocol registration, regulatory and policy issues) and the Office of Clinical Site Oversight (site management issues). - Stay abreast of new clinical research policies being developed by NIH/NIAID/DAIDS and ensures TRP is aware and provides input, as appropriate, for draft policies and procedures. - Work closely with the Regulatory Affairs Branch on regulatory and protocol registration issues as appropriate for TRP clinical trials. - Coordinate TRP internal audit preparation and responses; Communicates audit responses with other scientific programs and offices within DAIDS. - Conduct internal TRP program evaluations for the Quality Management System. - Assist with the development of new and/or update of existing TRP policies and procedures, as required. - Provide centralized support for NNCTs, including coordinating site activation activities with relevant staff. - Assist in the development of risk management plans and mitigation of identified risks. Specific Qualifications: - Minimum of a B.S./B.A. degree and 10 years experience in clinical trial management including budget management. - All support positions required a minimum of a BS degree; some require a MS, MD, or Ph.D. - The education, skills and relevant years of experience required for each support position are consistent with those identified as the minimum requirements for the labor categories specified in the contract. Benefits - 100% Medical, Dental & Vision premium coverage for Employees - Paid Time Off (Including Holidays) - Employee Referral Bonus - 401K Match - Tuition reimbursement and professional development opportunities - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program (DCAP) - Transportation Reimbursement Account (TRN)   The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.   Accessibility: If you need an accommodation as part of the employment process please contact:careers@axleinfo.com    Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required
ID
2022-2497
Job Locations US-MD
Axle Informatics is a bioinformatics and information technology company that offers innovative computer services, informatics, and enterprise solutions to research centers and healthcare organizations around the globe. With experts in software engineering, bioinformatics and program management, we focus on developing and applying technology tools and techniques to empower decision-making and accelerate the discovery in translational research. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of health (NIH).
ID
2022-2496
Job Locations US-MD-Rockville
Axle Informatics is a bioinformatics and information technology company that offers innovative computer services, informatics, and enterprise solutions to research centers and healthcare organizations around the globe. With experts in software engineering, bioinformatics and program management, we focus on developing and applying technology tools and techniques to empower decision-making and accelerate the discovery in translational research. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of health (NIH).     We have mulitple positions open for Sr. DevOps Engineer with primary focus on (Linux, Docker, Kubernetes, Open Source stack) to work at our North Bethesda, MD location.    Responsibilities:   - Planning, analysis, design, implementation and maintenance of networks, virtual machines, container solutions, storage, open source applications, and variety of databases in both cloud and on on-premise hosting environments - Perform computing environment buildouts, process automation, site setup, user training, hardware/software installation, maintenance and support, and documentation of operating procedures and processes - Lead migration of infrastructure resources from on-premise to cloud environments and utilize toolchain, scripts, automation for each stage in the infrastructure deployment - Monitor, track, report, and proactively address issues taking a holistic view of system health and supportability requirements, including documentation, monitoring, logging, high availability configuration, capacity and disaster recovery plans. - Configure and utilize a variety of network management, log analysis, monitoring and alert management tools - Providing advanced system administration, operational support and problem resolution for a large and complex Unix/Linux, windows workloads and applications hosted on a high-performance computing environment on both in cloud and on-premise. - Work closely with development, quality assurance, business analysts and architects to improve systems and refine processes for efficiency. - Provide superior customer service, including response to escalations, testing, support, server recovery, and troubleshooting functions - Stay in tune with new technologies in your areas but not limited to cloud computing & deployment, site reliability engineering, network design/architecture, infrastructure automation, security best practices, data engineering etc. - Advise team and management on process improvements and opportunities for automation. - Plan and execute defined DevOps and related technical project tasks. - Apply extensive knowledge of DevOps engineering principles and advanced techniques to manage the timely resolution of unprecedented issues. - Coordinate with subject matter experts across the release lifecycle to obtain input and support for planned DevOps engineering activities.   Qualifications:   - Must have 5+ years of hands-on Unix/Linux experience that includes specific technical experience with CentOS / Red Hat systems administration support for large scale distributed environments - Must have 2+ years of Cloud experience in at least one of the following providers Amazon AWS, Google GCP and Microsoft Azure - Must have cloud migration experience from on-premise datacenter to cloud platforms that includes assessments, cloud buildouts, optimization, support - Must have 5 years of experience working as part of the DevOps or systems reliability engineering functions - Must have 5+ years with CI/CD and automation tools such as Terraform, Ansible, Chef, Puppet, Jenkins, GitHub - Must have open-source stack experience and knowledge of packaging, build/deploy, monitor, and upgrade, security controls - Must have knowledge of one or more of applications stack but not limited to NodeJS, Angular, PHP, Java, .NET, Python etc. - Must have strong knowledge and experience of docker containers and orchestration using Kubernetes - Great understanding of networking concepts such as virtual networks, subnets, DNS, network hardening etc. - Must be willing to learn new technologies, adopt and adapt to emerging technologies or needs from a project to a project - Fundamental knowledge of data engineering technology stack or platforms including but not limited to Apache Spark, Kafka, Hadoop, Distributed Computing or similar big data applications/platforms is desired but not mandatory - Fundamental knowledge of SQL and/or NoSQL databases, object storage, web servers, open source programming stack for Node.JS, R, Python, Java is desired but not mandatory - Sound judgment, positive attitude, and creative outlook required. - Cloud certifications is preferred but optional - CCNA or CCNP or similar certifications is preferred but optional - Bachelors degree in Computer Science / Statistics / Bioinformatics / Computational Biology or closely related field is desired but not mandatory   Benefits:   - 100% Medical Dental & Vision Coverage for Employees​ - Educational Benefits for Career Growth​ - Paid Time Off (Including Holidays) ​ - Employee Referral Bonus ​ - Profit Sharing - 401K Matching​ - Flexible Spending Accounts: - Healthcare (FSA) - Parking Reimbursement Account (PRK) - Dependent Care Assistant Program (DCAP) - Transportation Reimbursement Account (TRN)   The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.     Accessibility: If you need an accommodation as part of the employment process please contact careers@axleinfo.com.      Disclaimer: The above  is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job . This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job  or responsibilities as needed.
ID
2022-2495
Job Locations US-MD-Rockville
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH) Overview We are seeking an experienced Sr Full Stack Developer to join our Team in North Bethesda, MD. This position has the option to work fully remote.  At Axle Informatics, we work with a number of different clients and data modalities within the field of image processing. You will be working with a multidisciplinary team of developers, data scientists, and engineers to design and build web applications to support the development and deployment of these image processing pipelines. Our pipeline utilizes modern containerization and container orchestration tools in a cloud-based environment. Your applications will focus on enabling researchers and data scientists to explore their datasets, regardless of modality and scale, in an unified web environment.  Responsibilities - Build scalable, reliable, and flexible web applications in TypeScript using NodeJS and Angular 9+ - Design, implement, and/or use RESTful web services - Implement modern and responsive UI for the web and variety of devices from detailed mockups - Participate in agile software development, prototyping, testing, and code reviews with a small team of developers - Write robust unit and end-to-end tests Basic Qualifications - Bachelor’s Degree in Computer Science, Data Science, Bioinformatics or other related field (years of work experience will be considered in lieu of degree) - 3+ years experience working with TypeScript/JavaScript - 3+ years experience as a full-stack developer - Experience with the following is preferred: - Node.js - Angular 9+ - NoSQL databases (MongoDB) - Containers and container orchestration tools (Docker, Kubernetes) - DevOps tools (Jenkins, GitHub Actions) - Web components - Familiarity with VCS such as Git - Experience with unit and end-to-end testing frameworks   Relevant Skills   - Critical thinking, problem solving, and attention to detail - Clear, concise communication - Technical writing ability - Familiarity working in an Agile environment - Attention to detail when building applications from mockups Benefits  - 100% Medical, Dental & Vision premium coverage for Employees   - Paid Time Off (Including Holidays)   - Employee Referral Bonus   - 401K Match   - Tuition reimbursement and professional development opportunities  - Flexible Spending Accounts:  - Healthcare (FSA)  - Parking Reimbursement Account (PRK)  - Dependent Care Assistant Program (DCAP)  - Transportation Reimbursement Account (TRN) The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.   Accessibility: If you need an accommodation as part of the employment process please contact:  Email: careers@axleinfo.com    Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.      
ID
2022-2494