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Associate Director, Clinical Data Management

Workforce Genetics

Associate Director, Clinical Data Management

Gaithersburg, MD
Full Time
Paid
  • Responsibilities

    Workforce Genetics is looking for a motivated Associate Director, Clinical Data Management for an emerging biotech company in Maryland. Our client is one of the most exciting cell therapy companies in the region and will be expanding their Clinical team as they transition several programs to clinical trials.

    About the Role: 

    The Associate Director, Clinical Data Management will have a strong understanding and demonstrated expertise with leadership of clinical data management and successful CRO oversight. His/her functions will include oversight of outsourced clinical data management activities, development of clinical trial data management documents, and shaping further development of the data management function . The successful candidate will be responsible for serving as the subject matter expert for clinical data management for the assigned program(s).

    Responsibilities: 

    • Oversees performance of vendors for outsourced functions
    • Responsible for delivering actionable clinical data from assigned clinical program(s)
    • Establishes metrics for data management, oversees vendor performance relative to expectations, and devises operational efficiencies where needed
    • Provides strategic, tactical and operational input to cross functional team
    • Translates development goals into relevant, tangible and measurable objectives for the clinical development team and drives optimal delivery
    • Engages key stakeholders to ensure expectations of clinical development operations are being met or exceeded

    Qualifications:

    • Bachelor’s degree required, Master’s Degree or greater preferred
    • 12+ years of experience in oncology clinical data management in either a Sponsor or CRO organization
    • 7 years of experience in a leadership role within clinical data management
    • Experience overseeing CROs and/or other vendors on a clinical trial
    • Experience with cell therapy clinical trials
    • Experienced in hematologic malignancies and corresponding clinical data