Description:
The Project Manager is responsible for the management of, as well as the delegation of responsibility for ongoing management and oversight of clinical trial study projects as assigned. The Project Manager will direct activities to meet our client’s specifications, ensuring quality deliverables are on time and within budget.
Responsibilities
- Provides ongoing oversight for clinical trial projects assigned, including client meetings and communications, report development and review, issue resolutions, and budget oversight.
- Independently leads medium to high complexity, multi-regional (>2) global projects which may include oversight and leadership of supporting co-PMs and regional LabConnect PMs.
- Participates in the handover process between Business Development (BD) and the Project Set-Up Team and in the training process of internal staff and handover from Set-Up to the PM.
- Primary project contact with Sponsors and Contract Research Organizations to ensure appropriate communication channels are maintained and reporting schedules adhered to.
- Serves as first point of contact for management issues related to clinical trials.
- Works closely and in coordination with clinical laboratory management and directors in support of clinical trials.
- Maintenance of project Dashboard including risk register (portions may be delegated)
- Review of reports and documents, including enrollment logs, pending test reports, reporting from other laboratories, issue logs, shipping manifests, and other documents that assist with study oversight.
- Review and analyze operational, quality, and performance related metrics to assess the success of study oversight activities.
- Liaise with managers/supervisors in other departments to stay informed of operational changes.
- Collaborate with project managers in partner laboratories to provide a global overview of study management.
- Interfaces with Laboratory Services, Site Support Services, Project Coordinators, Digital Tracking, Business Development, Finance, Project Management, external Project Management, Specimen Management, Information Technology and Data Management personnel to ensure support and deliverables are met as outlined in specification documents and contracts.
- Coordinate requests for shipment of stored samples as directed in the SOW.
- Ensures that all laboratory requirements outlined in the protocol are managed per expectations and in compliance with laboratory practices.
- Creates training materials for investigator meetings as applicable.
- Represents LabConnect at client and/or investigator meetings.
- Performs other related duties and tasks as necessary or as assigned.