Project Manager RTSM

Job Summary

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).

Duties

• 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.

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.

Education

• Bachelor's degree or equivalent experience required.