Project Manager, RTSM

Planet Pharma; San Francisco (CA); On-site; USD 82,656 - 96,432; Full time

Job summary

Planet Pharma is seeking a RTSM Project Manager in San Francisco. This role supports the Project Management of RTSM, including design, implementation and ongoing management of RTSM (IRT).

You will lead cross-functional study teams through scope changes, assess risks, and oversee system requirements, UAT, and issue resolution. Requirements include a Bachelor’s degree or equivalent and at least 6 years of operational experience in clinical trials with pharma/CROs, plus knowledge of clinical

Qualifications

• Bachelor’s degree or equivalent experience required
• 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

Responsibilities

• 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

Project management

Clinical operations

Vendor management

Data management oversight

Education

Bachelor’s degree or equivalent

Job description

Pay 60-70/h depending on experience

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

Requirements:

• Bachelor’s degree or equivalent experience required


• 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