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/Clinical Data Manager to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of Allergy, Immunology, and Transplantation (DAIT), Clinical Research Operations Program (CROP), Rockville, MD.
- Act as subject matter expert (SME) for all data management activities including proper data entry and tracking, human subject’s protection, data confidentiality and related IT security.
- Develop and maintain a proficiency in accessing and reviewing clinical study related information from databases used by DAIT and/or NIAID and additional relevant clinical data databases including those of DAIT’s clinical research organization (CRO) awardees, ImmPORT and ClinicalTrials.gov.
- Provide expertise to sponsor clinical data management projects on multiple complex studies and programs, both internal and performed by supporting clinical research organizations (CROs).
- Provide technical oversight of CROs performing core data management functions including case report form (CRF)/edit check development, user acceptance testing, data cleaning, listings review, and database lock procedures.
- Responsible for the oversight of clinical data management study deliverables, evaluating and mitigating data management risks.
- Provide expertise to assist in CRF and database design.
- Assist in the development and implementation of data transfer and migration plans relating to transitions between CROs.
- Perform or oversee development of clinical data management validation plans, data transfer requirements and agreements, and data management plans.
- Provide expertise in support of developing sponsor data management SOPs, procedures, PWIs, Plans, Guidance and other quality-related documentation.
- Devise and oversee implementation of quality assessment procedures according to data management plans and other means.
- Assess the quality of the statistical programming processes through techniques including, but not limited to, good documentation code review and testing.
- Assist with the creation and review of CAPAs related to clinical data management.
- Review and process clinical trial data to ensure data quality for data analysis.
- Participate in clinical study data reviews and other activities related to database lock.
- Participate in multi-party clinical data process development initiatives.
- Assist in the development of data pathways and system interconnection arrangements.
- Provide input on clinical data management system enhancements including design, review, performing user acceptance testing and validation supporting activities.
Experience Required / Requirements
- Master’s degree in a related discipline required. A PhD in a related discipline is a plus.
- At least five (5) years of clinical data management experience is required.
- Excellent verbal and strong written communication skills are required as this person is expected to interact with team members from various disciplines every day.
- Excellent analytical, organizational and time management skills required.
- Thorough understanding and experience with GCP/GxP, Privacy Act and quality requirements are required.
- Working knowledge of clinical data management tools is required.
- Experience programming and using Medidata Rave, Oracle Argus and RedCap preferred.
- Familiarity with clinical trial data standards such as CDISC preferred.
- Experience in developing eCRFs and clinical databases required.
- Experience creating and evaluating clinical data management plans and agreements preferred.
- Experience working within a quality-driven environment is preferred.
- Experience creating and evaluating SOPs and CAPAs required.
- Systems validation experience preferred.
- Knowledge of data systems architecture and structure of data systems is required.
- Pharmaceutical industry experience is a plus.
- Excellent computer skills, proficient in Microsoft Office, SQL and XML required.
- Experience with statistical software such as R, SAS, Stata, & SPS preferred.
- 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:
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.