Location
Bethesda, MD | United States
Job description
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
Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Clinical Operations Manager to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS ( DAIDS(.Therapeutics Research Program(TRP).
Responsibilities - Support the TRP OD to coordinate administrative and operational matters.
- Support TRP OD to plan and implement programmatic initiatives.
- Participate in collecting and reviewing TRP quarterly scientific advancements.
- Coordinate with Branch Chiefs and TRP OD to update network and non-network trial tracker quarterly and provide analysis when needed.
- Coordinate clinical review activities and meetings for the TRP portfolio, including supporting the Clinical Science Review Committee (CSRC) and completing pre-review tasks for NIAID
- Data Safety and Monitoring Boards (DSMB).
- Participate in preparations for internal TRP audits and responses, ensuring effective communication of responses within the TRP and with other DAIDS scientific programs and offices.
- Conduct internal evaluations of program training for the TRP Quality Management System.
- Stay informed about TRP program-level or protocol-related issues, collect TRP staff input, and participate in the development or update of TRP policies and procedures.
- Provide centralized storage support and act as the TRP point of contact for issues and activities related to uploading network and non-network trial files to DAIDS systems, including DAIDS eDR, TMF, BOX, and SharePoint.
- Participate in the formulation of risk management plans and strategies to mitigate identified risks.
- Coordinate and manage ad hoc special projects for TRP OD.
Experience Required / Requirements - Minimum qualifications include a B.S./B.A. degree; preferred M.S./M.A./M.P.H. or equivalent degree with experience in clinical trial management.
- Minimum of two years of experience in a related field
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 protected]
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.
Job tags
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