Title: Project Manager, RTSM
Location: San Francisco, CA 94158
Duration: 4+ Months Duties:This position is responsible for Supporting the Project Management of RTSM including (but not limited to) the design, implementation and ongoing management of RTSM (IRT).
- Provide advice/recommendation to study teams regarding system design alternatives.
- Provide leadership and subject matter expertise for the completion of set-up activities and through lifecycle of the system.
- Lead the cross functional study team through changes of scope, providing technical expertise, assessment of risk, oversight of system requirements updates and user acceptance testing
- Lead the resolution of issues escalated by study teams as well as cross-team specific issues
- Define the data review requirements in collaboration with Data Management. Participate in data management oversight reviews.
- Define critical document list in collaboration with Clinical Documentation team. Participate in Trial Master File oversight reviews.
- Ongoing management of timely query resolution.
- Serve as the point of contact specific to inspection readiness activities between the study team and the RTSM supplier.
- Support the study team in close-out/deactivation of the RTSM system
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Skills:
- At least 6 years operational experience in clinical trials with a pharmaceutical
company and/or a Clinical Research Organization is required - Demonstrated knowledge of clinical development processes, global clinical operations, and strategic planning is required
- Familiarity with industry best practices for vendor management is required
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We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.
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