Sr. Clinical Project Manager- Cambridge, MA (2 to 3 days of remote flexibility)
A highly successful pharmaceutical corporation is seeking to hire a Global Clinical Project Manager (CPM) for their biopharmaceutical hub located in Cambridge, MA.
The Senior Clinical Project Manager (CPM) will:
- Oversee and drive all aspects of the assigned global international clinical study(ies) outsourced to a CRO in respect of planning/timelines, quality, budget and defined goals
- Drive execution and report activities in conjunction with Clinical Development Program Directors (CDPDs), Medical Dev. Directors (MDDs), and other team members
- Endorse project plan developed by the CROs in accordance with study objectives and the pharmaceutical company's requirements in terms of team responsibility, risk mitigation plan, escalation process, communication plan...
- Ensure the Global clinical studies are managed according to Good Clinical Practice (GCP), local regulations, guidelines and SOPs in the required standard of quality
- Communicate and share the progress of the project, and work effectively as a Team
- Lead, Manage and Drive the cross-functional Clinical Study Team and Contract Research Organization (CRO) in collaboration with the CDPDs and team members responsible of the study
- Oversee and drive cross-functional leadership and expertise to ensure effective contribution, execution and delivery of study activities as per quality, plan/timelines and budget
- Foster a team approach to all activities associated with the implementation, conduct and closing of clinical studies including clinical study team members (TA, Biometry, Pharmacovigilance, Finance controlling, Global Regulatory Affairs, CMC Supply chain…) and CROs
- Establish and maintain excellent professional relationships with Services Providers / CROs, clinical study team through regular communication, between company, investigators and experts in conjunction with Medical Dev. Director (MDD) and other relevant team members
- Lead cross-functional clinical study teams focused on conduct of assigned projects
- Interact with CDPD to define strategic direction
- Review status reports provided by Service Provider/CRO and highlight issues to facilitate decision making
- Manage and lead all operational aspects for implementation and conduct of global clinical trial activities from study start-up to CSR, in respect of GCPs and relevant SOPs
- 5+ years of clinical Project management experience
- The ideal candidate must have strong project management skills, be able to be a leader, work independently, highly organized and be able to prioritize different tasks.
- Oncology experience is required.
- He/she must have experience preparing clinical study documents from study set up, maintenance and closing.
- Must have experience in managing and developing relationships with Contract Research Organizations (CROs).
- The Global Clinical Project Manager (CPM) should have good knowledge of Good Clinical Practice (GCP), ICH regulations.
If you or a Global Clinical Project Manager you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at Sara.Shields (at sign) Realstaffing.com to discuss this role. Thanks!
Sthree US is acting as an Employment Agency in relation to this vacancy.