Clinical Project Manager

Proclinical is currently recruiting for a Clinical Project Manager with a pharmaceutical company located in Philadelphia, PA.

Job Responsibilities:

• 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.

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