**Hybrid Role in Boston, MA**
Job opportunity with a top biopharmaceutical company that is looking for a Clinical Project Lead III to join their team on a 6-month contract with a possibility for conversion or extension!
- An advanced degree (Master, PhD, MD) is desirable.
- PMP certification is desirable.
- 10 years of clinical research experience, 5 of which in a leading role accountable for the planning and execution of global clinical trials, non-interventional, relevant post-marketing studies, and/or early access programs.
- Accountable for the planning, implementation, and execution of pivotal clinical trials, non-interventional and post-approval commitment studies (eg, Post-Approval Safety surveillance (PASS) studies), and/or early access programs, including study deliverables, milestones, and data quality. Lead the Clinical Trial or other study Team. Provide management oversight of CROs and relevant study vendors.
- Oversee third-party vendors to operationalize the study specifications.
- Directs operational execution of study activities in accordance with SOPs, ICH Guidelines, and Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP) to ensure overall data quality, integrity; and patient protection as applicable.
- Accountable for planning, tracking, and forecasting the Global Clinical Operations budget and timelines for the studies against the agreed goals. Develops and maintains budgets for study(s) that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development or Global Medical Affairs financial goals.
- Manages CRO relationship to ensure the appropriate scope of work, oversight, and training of clinical investigators, and achievement of study milestones within agreed-upon timelines and budget.
- Health Insurance
Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?