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 Data Management/Clinical Advisor to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS), Office for Policy in Clinical Research Operations (OPCRO), Rockville, MD.
- Provide expert leadership to oversee sponsor Clinical Data Management project timelines on multiple complex clinical trials or programs.
- Provide technical leadership and oversight of service providers 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, evaluate and mitigate risks across programs on behalf of the Division of AIDS.
- Conduct data reviews.
- Review the development of database specifications, validation plans, and data management plans, ensuring alignment with CRFs, protocol, and safety data standards.
- Lead and participate in cross-functional data management-related process initiatives on behalf of the Division of AIDS.
- Responsible for overseeing the end-to-end data management clinical trial related activities on a day-to-day basis and is the ultimate accountable person for the data management study deliverables in terms of quality and delivery according to plan.
- Provide leadership and oversight of data management activities, including: Implementation of data management aspects of clinical protocols and data collection systems; Strategic input into proposal or protocol design focused on data management considerations; Mitigation of potential data management issues by reviewing protocols for cross-project consistency and identifying standard case report form modules to meet objectives; Reviewing data management activities and recommending process improvements; Maintaining high-level oversight on data quality metrics and data management deliverables.
Experience Required / Requirements
- Industry (contract research organization or sponsor) work experience is required.
- Pharmaceutical company work experience is required.
- Experience working with all phases of clinical trials.
- At least seven (7) years of clinical data management experience is required.
- 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.