Clinical Project Manager
Our team is seeking a Clinical Project Manager to join our experienced and talented clinical development team. As a Clinical Project Manager, you will lead cross-functional study teams in the development and execution of clinical trials. You will be responsible for delivering trials with quality, on time, and within scope.
Key Responsibilities:
1. Develop and execute local, regional and/or global clinical trials using project management skills, processes and tools.
2. Partner with other organizations to coordinate affiliate, site, and investigator training.
3. Drive and coordinate local, regional and global, cross-functional study teams throughout study implementation, execution, and closure.
4. Be accountable for trial/regional enrolment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET).
5. Manage relationships and serve as a single point of contact and central owner for trial communication to and from the Clinical Development team.
6. Apply problem-solving skills to daily issues with cross-functional study teams (including with vendors, affiliates/regions, global team members and other business partners).
7. Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc.
8. Manage TPO qualification process, selection, and oversight.
9. Accountable for ensuring a state of inspection readiness of the TMF records created, maintained, finalized, and owned by Clinical Development.
10. Apply expertise and knowledge of global/regional regulations & Good Clinical Practice (GCP) and leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents.
11. Combine scientific, regional, and operational knowledge as well as process expertise to impact clinical trial design, feasibility and implementation.
12. Utilize clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business.