1.Primary interface for parent company in China and CROs to ensure the timely initiation and completion of clinical trials.
2.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.
3.Monitors the status of clinical data collection of assigned clinical trials.
4.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.
5. 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.
6.Prepares and reviews study-related documents when required.
7. 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.
8. Evaluates issues found in clinical studies, communication and oversight of CROs and vendors, and suggests and implements solutions and mitigations as required.
9.Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight. Requirements
1. 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.
2. Successful track record of CRO oversight or clinical project management.
3. •Ability to work collaboratively with team members in parent company in China, as well as with external collaborators including investigators, CROs and vendors.
4. Strong interpersonal skills and capability to influence team members to accomplish work without formal authority.
5. Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders
6. Strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
7. Experienced in evaluating outcomes of clinical trials and basic knowledge of clinical trial outcome standards.
8. Strong analytical skills with a data driven approach to planning, execution and problem solving
9. Thorough understanding of the oncology field and working knowledge of current global regulatory requirements and guidelines for clinical trials.