Clinical PM / SPM

Department
部门

R&D, Clinical Operation
Title
职位
(Sr.) Project manager
Starting Date
任职时间

–

Direct Report
直线经理
PM Director
Direct Subordinates
直接下属
–
Primary Function
主要职能
  • 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.
  • 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.
Qualifications
资格要求
  • 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.