AddressPosition Objective: Provide services as a Clinical Program Manager in support of the overall functions of the Division of AIDS (DAIDS), Translational Research Program (TRP) within the National Institute of Allergy and Infectious Diseases (NIAID).
Duties and 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.
Basic Qualifications:
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.
Minimum Qualifications:
Ability to communicate effectively, orally and in writing, with non-technical and technical staff.
Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects
*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.
GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.
This position is contingent upon contract award.
Requisition ID: 6710
