Clinical Project Manager
Proclinical is currently recruiting for a Clinical Project Manager with a leading research development company located in San Francisco, CA. As the Clinical Project Manager, you will be responsible for clinical operational oversight as well as the execution of all assigned studies, monitoring of study deliverables, performing protocol-related site management activities, participating in study planning and set-up activities including vendor management, project management, coordination of study and implementation plans and supporting third party vendor relationships.
- Responsible for the oversight and day-to-day management of clinical operations activities e.g. milestones, deliverables and timelines, for one or more clinical studies.
- Ensure that the planning, implementation, coordination and reporting of the clinical studies in line with the corporate objectives.
- Act as a key study contact for studies and effectively plan and communicate study milestones, deliverables, timelines and quality standards to other functions and other stakeholder groups.
- Support and mentor team of Associate Clinical Project Managers/Clinical Project Managers assigned to studies.
- Line management of other clinical operations personnel when required/opportunities arise.
- Support and monitor CRO and third-party vendor activities, including IMP management, Investigator contract/budgets, TMF management, study set-up, project management, biostatistics and medical writing.
- Monitor progress of studies, identify study-related trends/issues and work with the Senior Clinical Operations team to implement corrective actions when necessary.
- Attend site visits (including, but not limited to, Site Initiation Visits and study surgeries) where local and national travel policies allow.
- In conjunction with Surgical Technical Expert Liaison, oversee execution of the Surgical Training Plan.
- Adopt a Risk Management approach to oversight and execution of assigned clinical studies.
- Coordinate with CMC for the shipment of IP and ancillary supplies to investigator sites.
- Coordinate and/or lead contract and budget negotiations with sites and third-party vendors.
- Lead study operational and/or scientific feasibility, and site set-up activities as per clinical operations strategy.
- Prepare study training materials and present at Internal Workshops and Investigator Meetings.
- Set up and chair study meetings when required, including DSMB.
- Ensure study certifications, insurance, licenses and registrations are maintained.
Skills and Requirements:
- 5+ years' experience working as a (Snr) Clinical Project Manager in Phase I-IV studies within the pharmaceutical industry or a CRO.
- Extensive experience in direct management of study start up activities.
- Independent thinker with ability to anticipate issues and risks and to mitigate accordingly.
- Team player who is able to prioritize workload in a fast-paced environment.
If you are having difficulty in applying or if you have any questions, please contact Funmi Gbadamosi at (+1) 424-361-3900 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.