Clinical Project Lead
Job Description
The Clinical Project Manager will be responsible for leading cross-functional study teams in the development and execution of clinical trials.
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 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 for trial communication.
6. Apply problem-solving skills to daily issues with cross-functional study teams.
7. Identify and develop continuous improvement activities based on industry trends.
8. Manage Third Party Organization qualification process, selection, and oversight.
9. Ensure a state of inspection readiness of 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 technical consultation for clinical and regulatory documents.
11. Combine scientific, regional, and operational knowledge to impact clinical trial design, feasibility, and implementation.
12. Utilize clinical development knowledge, problem solving, and critical thinking skills to support scientific needs.