Be accountable for the implementation, management and reporting of assigned clinical trials, drive the execution of the clinical studies in compliance with ICH-GCP, including but not limited to study planning, study start-up, execution, control study budget and quality, monitor progress, CRO/vendor selection and management, develops and manage all study plans in collaboration with the CRO if applicable.
Be a key member of product project team working closely with R&D key functions on product development plan and execution, provide input and contribute from clinical operation function.
Major Responsibilities and Duties主要职责和任务:
Ensure successful clinical trial startup and conduction, accountable for all study aspects and ensuring meeting timeline, budget and quality requirement.
1. Support IND filing on study related documents preparation, e.g. protocol, ICF, IB etc.
2. Manage study planning and startup all activities including not limited to country/site selection, FDA/NMPA submission, study TMF preparation, vendor/system set
-up, Clinical trial materials planning and readiness at depot, study plan development etc.
3. Manage trial enrollment and monitor overall progress, make mitigation/action plans and execute ensuring enrollment hit target.
4. If applicable, lead company functional team on CRO selection, manage and monitor performance of all CROs ensure delivering on time and high quality.
5. Manage several of clinical vendors’ contract and overseeing their performance
6. Have responsibility for the financial management of the clinical trial including budget planning, resource allocation and preparation of quarterly reports.
7. Train and coach CRAs in various aspects of management (e.g. HR, budgets, and resource allocation) that are relevant to project issues
8. Work as product level project team member and contribute from clinical operation perspective.
9. Identify/monitor risks, and develop mitigation, contingency plans as necessary
10. Serve as a liaison for company with our overseas or domestic clinical CROs
1. Medical degree and above
2. Major in clinical medicine, pharmacy or relevant;
3. Experienced in clinical trial area and preference on
? >6 years clinical trial related experience & >3 years trial management
? previously worked in global pharma or CRO and/or early development functions
4. Knowledgeable to China regulatory and clinical requirements, with experience of interacting with regulatory agencies, e.g. FDA, NMPA
5. Solid understanding of GCP and Drug development
6. Ability to work independently and collaborate
7. Strong communication skills and leadership
8. Strong oral and written communication skills in Chinese and English