• Program Manager/Clinical Portfolio Manager - Clinical Trials

    Job Locations US-MD-Silver Spring
    # of Openings
    1
    Type
    Regular Full-Time
  • Overview

    CAMRIS International is seeking a Program Manager/Clinical Portfolio Manager for a potential position supporting clinical trials at the Walter Reed Army Institute of Research (WRAIR). 

    Responsibilities

    Manage all clinical trial development initiatives. Serve as the primary point of contact for CTC staff. Prepare and manage budgets for all clinical trials and related projects. Assist with preparing the Knowledge Management Plan (KMP) for the CTC. Work closely with the Contracting Officer’s Representative (COR) to monitor, verify, and reconcile expenditure of budgeted funds supporting all clinical trials and other projects. Work closely with the Business Management Office (BMO) to initiate and track assistance agreements for the CTC (e.g., Cooperative Research and Development Agreements (CRADAs), Material Transfer Agreements (MTAs), Institutional Biosafety Committees (IBCs), applications, and Clinical Trial Agreements (CTAs)), ensuring full compliance of contract requirements, schedules, and provisions. Develop and/or provide support for Project Plans, including but not limited to plans for space, supplies and budget management for the execution of protocols. Review and monitor project scope, timelines and deliverables from project initiation to close out. Schedule monthly project team meetings. Compose submission memos and work with Principal Investigators (PIs) and CRCs to compile documents for protocol submission to the Institutional Review Board (IRB) and other review boards.

    Qualifications

    • Bachelor of Science Required, Advanced Degree preferred not required.
    • Minimum 10 years’ experience with clinical trial management of medical devices or clinical diagnostics required
    • Clinical research certification (such as CCRA, CCRC) is highly desired.
    • Strong experience in evidence planning, clinical strategy, study design/execution and study monitoring
    • Ability to work across a dynamic organization and influence internal and external stakeholders
    • Ability to resolve compliance or technical issues that may arise during clinical trials.

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