- Primary interface for parent company in China and CROs to ensure the timely initiation and completion of clinical trials.
- Provides oversight and management of CROs, consultants and vendors.
- Monitors progress of clinical activity and reports on the progress of assigned clinical trials including budget and timelines.
- Monitors the status of clinical data collection of assigned clinical trials.
- Performs on site co-monitoring visit to ensure the study conduct and quality according to the protocol requirement. Generates the co-monitoring report to provide issue identification and resolution advice to CRO.
- Engages the KOLs to discuss the compound development plan and protocol development detail. Prepares the potential investigator site lists and assists with their evaluation for inclusion in the study.
- Prepares and reviews study-related documents when required.
- Reviews and approves study-related plans generated by CROs and vendors, and ensures the documentations are in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies.
- Evaluates issues found in clinical studies, communication and oversight of CROs and vendors, and suggests and implements solutions and mitigations as required.
- Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
- S./M.S./Ph.D. in a scientific/healthcare field with clinical research or clinical operations experience (5+ years) within a pharmaceutical company, CRO or similar organization.
- Successful track record of CRO oversight or clinical project management.
- Ability to work collaboratively with team members in parent company in China, as well as with external collaborators including investigators, CROs and vendors.
- Strong interpersonal skills and capability to influence team members to accomplish work without formal authority.
- Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders
- Strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
- Experienced in evaluating outcomes of clinical trials and basic knowledge of clinical trial outcome standards.
- Strong analytical skills with a data driven approach to planning, execution and problem solving
- Thorough understanding of the oncology field and working knowledge of current global regulatory requirements and guidelines for clinical trials.
Job Type: Full-time
Salary: $80,000.00 to $120,000.00 /year
- Lexington, MA (Preferred)