R&D, Clinical Operation
(Sr.) Project manager
- 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
- Ensure successful clinical trial startup and conduction, accountable for all study aspects and ensuring meeting timeline, budget and quality requirement.
- Support IND filing on study related documents preparation, e.g. protocol, ICF, IB etc.
- Manage study planning and startup all activities including not limited to country/site selection, EC/HGRAC submission, study TMF preparation, vendor/system set-up, Clinical trial materials planning and readiness at depot, study plan development etc.
- Manage trial enrollment and monitor overall progress, make mitigation/action plans and execute ensuring enrollment hit target.
- If applicable, lead I-Mab functional team on CRO selection, manage and monitor performance of all CROs ensure delivering on time and high quality.
- Manage various of clinical vendors contract and overseeing their performance
- Have responsibility for the financial management of the clinical trial including budget planning, resource allocation and preparation of quarterly reports.
- Train and coach CRAs in various aspects of management (e.g. HR, budgets, resource allocation) that are relevant to project issues.
- Work as product level project team member and contribute from clin. Ops perspective.
- Identify/monitor risks, and develop mitigation, contingency plans as necessary.
- Bachelor’s degree and above.
- Major in clinical medicine, pharmacy and biology or relevant.
- Experienced in clinical trial area and preference on
- >6 years clinical trial related experience.
- Previously worked in global pharma or CRO and/or early development functions.
- Knowledgeable to China regulatory and clinical requirements, with experience of interacting with regulatory agencies, e.g. CDE, HGRAC, CFDI.
- Solid understanding of GCP and Drug development.
- Ability to work independently and collaborate.
- Strong communication skills and leadership.
- Strong oral and written communication skills in Chinese and English.