SENIOR CLINICAL PROJECT MANAGER
Boston, Massachusetts - United States
Seeking dynamic and highly experienced and motivated Sr. Clinical Project Manager to join a small biotech company focused on the most comprehensive portfolio with very impressive industry leaders. Seeking a skilled and confident Senior Clinical Project Manager (Cell Therapy) to manage and lead the trial report study activities. Will work closely with upper management on strategies to drive successful executions for their first-in-class programs and robust portfolio.
- Lead and manage the CRO with all clinical trial studies and drive plans and strategies.
- Oversee all clinical study activities and ensure strategy, support, implementation, and execution of trial studies per company plans and timelines, and budget for clinical studies within multiple clinical programs.
- Work with and support management with strategies on studies or programs.
- Lead and manage the operational aspects for implementation and global trial studies activities from study viability to CSR, regulatory requirements, GCPs, and SOPs.
- Skilled in handling complex or difficult situations (or trial projects) to meet the goals of the study.
- Will be responsible for managing the activities and deliverables of all study content by providing effective study reporting, submission activities, audits, and inspections.
- Advanced degree in a Scientific discipline required; medical graduate or other life science (MD)
- In-depth knowledge of regulatory requirement (ICH E6, GCP, EU Directive)
- Prior experience leading, managing, and developing CROs and any other external partnerships
- Strong working experience/knowledge in Clinical Research (10 years) with Clinical Project Management of relevant clinical dev studies (8-10 years) within a pharma/biotech setting.
- Cell Therapy or CAR-T therapeutic focus is strongly desired
- Prior experience working in a matrix environment.
- Leadership and prior management experience
- Strong presentation, communication, and interpersonal skills.
- Broad knowledge of the drug development process and has strong relationships with the investigators.
If interested in learning more, please contact Bria Gaber at email@example.com for more information.