Clinical Project Manager
Proclinical is currently recruiting for a Clinical Project Manager with a pharmaceutical company located in Philadelphia, PA.
- Establish study-specific oversight plans and ensure adherence and review
- Ensure protocol deviation meetings are conducted per plan
- Facilitate internal audit / corrective and preventive action (CAPA) management: contribute to the resolution of CAPA
- Manage TMF filing of Clinical Operations documentation
- Proactive management of study specific timelines to ensure activities occur as contracted
- Ensure Quarterly budget review meetings are performed, undertake review of budget and scope of work
- Work proactively to ensure the study remains within the agreed scope and budget
- Initiate Change Order (CO) activities as required
- Proactive management of clinical projects to ensure issues are identified and solutions established
- Serve as protocol subject matter expert for assigned study
- Contribute to the development of standard metrics used to routinely monitor study activities
- Perform day-to-day management of the study team as required, including leading team meetings and provision of study training
- Monitor study enrollment and retention. Act on deviations from plans
- Identify barriers to enrollment and support recruitment and retention strategic solutions
- Monitor and act upon study metrics (review, trend-identification and analysis, with targeted follow up where appropriate)
- Review Monitoring Visit Reports
- Ensure accuracy of information for study presented in status reports (CTMS)
Skills and Requirements:
- required- preferably in a life science field or equivalent, (includes RN degree)
- Master's or PhD. Preferred
- Healthcare professional with at least 5 years of clinical experience, or Science Graduate with at least 4 years' experience as a Clinical Research Associate / Senior Clinical Research Associate, with a track record in successfully managing clinical trial sites.
- Prior project management experience required
- Experience of oncology clinical trials and cancer therapies
- Prior experience in a CRO/pharmaceutical environment preferred
If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.
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.