Clinical Project Manager
Proclinical is currently recruiting for a Clinical Project Manager for a global pharmaceutical company located in Bridgewater, NJ. As the Clinical Project Manager, you will plan and manage overall clinical operations for assigned global clinical trials/programs. This includes timelines, budgets, resources, investigational sites, vendors and key project deliverables.
- Lead and manage multidisciplinary Clinical Trial Teams to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices.
- Serve as the primary contact with CRO and act as team leader of the study work group.
- Work with outsourcing manager to prepare clinical outsourcing specifications.
- Participate in the selection of CRO.
- Contribute to and initiate process improvement initiatives.
- Establish project milestones, budget and timelines for the study in partnership with the study team and outsourcing manager.
- Participate in the overall project planning and optimization with the Project Team.
- Work closely with the Medical Experts and Clinical Scientist for the design of the clinical trials within the program.
- Other duties as assigned.
Skills and Requirements:
- Bachelor's degree, preferably in a biologic/scientific discipline is required.
- Minimum of 5 years progressive experience in clinical operations including 3 years of clinical project management or equivalent with pharma, biotech and/or CRO is required.
- Systemic route of administration clinical trials experience required; pediatric, drug/device combination and biologics experience preferred.
- Thorough understanding of country-level regulations, ICH and GCP guidelines, cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs.
- Vendor management experience preferred.
If you are having difficulty in applying or if you have any questions, please contact Jacqueline Zafrani at (+1) 213-893-4997 or email@example.com.
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.