The Clinical Project Manager (CPM) is responsible for owning and achieving interim and final contractual deliverables for assigned projects/programs, according to time, quality/scope and cost constraints. The PM manages the execution of day-to-day work results for projects. The PM leads and directs cross-functional teams, understands, and manages client expectations/needs to achieve client satisfaction and ensures adequate internal and external communication of information. The PM proactively identifies, resolves/mitigates and escalates risks and/or issues. The PM adheres to ICH/GCP guidelines, local laws and regulations, and compant’s standard procedures and processes. Project manager may be responsible for coordinating country specific study activities within a multi country study and may report into a regional or global clinical PM who acts as primary client contact responsible for achieving contractual deliverables
Acts as primary liaison with client:
- Acts as lead contact for project matters.
- Understands/manages/satisfies client contractual, organizational and relationship needs/expectations.
- Oversees all start-up activities to ensure timely regulatory approval and study start.
- For NL & PPS Only – Oversees Regulatory timelines, preparation, submission and approval.
- Provides regular reporting on project metrics, status of deliverables and risks/issues with the associated management plan to client.
- Chairs and leads customer meetings and documents meeting outcomes.
Leads and directs cross-functional team leaders and third parties/vendors with close supervision and support:
- Oversees, coordinates and reviews work produced by project team members per the agreed upon scope of work.
- Guides and supports team leads in project-specific prioritizing, trouble-shooting and contingency planning.
- Delegates whilst retaining ownership.
- Communicates project specific priorities to project team and provides guidance/mentoring as needed.
- Ensures up-to-date planning information is available to project team and rest of operational organization.
- Chairs internal project team meetings and documents meeting outcomes.
- Liaises with functional leads/managers to optimize performance and utilization of project team members.
- Provides feedback on project team member’s performance to respective line-managers
Manages project contractual deliverables (with close supervision):
- Monitors and ensures adherence to the contractual agreement (time, quality/scope, and cost deliverables).
- Proactively identifies and evaluates alternative solutions to resolve/mitigate and escalate risks and/or issues as appropriate
Manages project costs (with close supervision):
- Proactively and timely identifies, for assigned projects, ensuring out of scope activities are approved up front via a contract modification.
- Identifies potential or actual unrecoverable effort and provides analysis and mitigation/resolution plan for senior management’s approval.
- Ensures control of financial risk to PRA.
- In cooperation with the project analyst, applies efficient management of project pass-through costs and investigator payments for external non-PRA sites to ensure all such costs are recovered in a timely manner, and in advance where ever possible.
- Leads presentation of financial reviews and is accountable for action item follow up.
Ensures that the progress of a clinical trial is conducted and complies in accordance with the protocol, PRA’s Standard Operating Procedures (SOPs), ICH/GCP and applicable regulatory requirements at the project level.
Assumes project leadership role in compliance at project level to PRA processes and systems, including escalation to relevant functional and operational management.
May participate in and attend the bid defense process.
Support Business Development department by functioning as point of contact / consultant for clients and Business Development during sales cycle in general and more specifically during the RFP process. May serve as the Operational RFP Lead and take the independent lead in supporting the feasibility, proposal and budget process.
