IRT Project manager

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 Product, 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