Nextonic Solutions is seeking a highly ambitious, adaptable, structured, and detail-oriented Clinical Program 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

-B.S./B.A. degree; preferred M.S./M.A./M.P.H. or equivalent degree with experience in clinical trial management.

Job Type: Full-time