Clinical Project Manager
Clinical Project Manager - Cambridge, MA (2 to 3 days of remote flexibility)
A growing pharmaceutical company located in Cambridge, MA is looking for an experienced Clinical Project Manager (CPM) to join their team. The CPM assures that the study is conducted per protocol, per business requirements, and in accordance with applicable regulations and guidance. This individual will develop and manage the study project plan to ensure timely completion of key deliverables, as well as coordinate internal and external clinical development activities involving sites and all team members involved in the design and conduct of assigned clinical trials.
- Responsible for developing and managing approved trial budgets.
- Coordinate the development of project timelines and manage any changes thereto, including future timeline changes that may result from changes in scope, delays in schedule or resource constraints.
- Coordinating internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical studies.
- Manage study execution, including management and oversight CROs, vendors and consultants that are involved with the clinical trial.
- Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.
- Ensures risks are proactively identified, managed, and mitigation strategies implemented
Qualifications and Experience:
- 3+ years of direct clinical trial management experience working for a biotech or pharmaceutical company.
- Multi-study experience managing early through late stage clinical trials.
- Working knowledge of, and experience with, clinical trial design, conduct, data acquisition and reporting.
- Oncology or Rare Disease experience preferred.
- Working knowledge and understanding of key regulatory authorities, ICH Guidelines and Good Clinical Practice (GCP).
If you or a Clinical Project Manager you know feel this could be an opportunity you would like to explore please send me your most up to date resume c.garland (AT SIGN) realstaffing.com to discuss the role in further detail.
Sthree US is acting as an Employment Business in relation to this vacancy.