• Sr. Study Specialist, Global Study Operations

    System One (San Rafael, CA)


    Job Title: Sr. Study Specialist, Global Study Operations

    Type: Contract

    Compensation: $55.00 - $61.24 hourly

     

    Contractor Work Model: Hybrid (at least 2 days/week)

     

    Joule is currently recruiting or a Sr. Study Specialist. Ideally, this candidate will have a minimum of a Bachelor's degree and a background in global study operations.

     

    The ideal candidate will be tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets. The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.

    Responsibilities include but are not limited to:

    + Develop study specific documentation, as delegated by the Study Manager Contribute to the oversight of country and site feasibility assessment and site selection.

    + Oversee and manage essential documents in the Trial Master File (TMF) Contribute to Global Study Operations risks identification and mitigations.

    Skills:

    + Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets, POs, and invoice management (e.g., CROs, central labs, imaging etc.)

    Education:

    + BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.

    #LI-EL1

    Ref: #568-Clinical

     

    System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

     

    System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.