SENIOR CLINICAL PROJECT MANAGER
Remote - United States
Seeking experienced Sr. Clinical Project Manager to join a small group within a full-service CRO setting. Searching for an experienced & confident SR CPM to join a small team where you will have the opportunity to impact the business and shape the culture of the company. Someone who is highly motivated & enjoys working in a start-up mode to help create processes, revise SOP's, & more, would do well in this role.
- Lead and manage the business with all clinical trial project studies, and drive plans and strategies.
- Oversees all clinical study activities and ensures 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 SOP's.
- 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, Ph.D.)
- Strong working experience/knowledge in Clinical Research (7-8 years) with relevant Project Management experience with clinical development studies (5 years) in a pharma setting.
- In-depth knowledge of regulatory requirement (ICH E6, GCP, EU Directive)
- Prior experience leading, managing, and developing CROs and any other external partnerships.
- Oncology 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 you meet the above qualifications & interested in learning more, please contact Bria Gaber at firstname.lastname@example.org for more information.