Clinical Project Manager
Consultant Irene Lu
Date posted 15 November 2022shanghai Healthcare/clinical-and-medical-affairs 2022-11-15 2023-01-14 medical-and-nursing Shanghai Shanghai CN Robert Walters https://www.robertwalters.cn https://www.robertwalters.cn/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png
The position is accountable for the effective and efficient execution of clinical studies in China and potentially other APAC regions in accordance with regulatory requirements and internal procedures, including clinical studies for registration purpose, R&D investigational studies, and other types as required. Clinical evaluation activities may also be covered under this position.
- Take the lead role in the collaboration with internal and external stakeholders to develop appropriate clinical strategy to support regulatory requirements and achieve strategic and tactical goals
- Be accountable for whole-process management of multiple multi-center clinical study startup and execution simultaneously:
- Define project plans, identify critical project success factors for tracking, analysis and reporting, establish project reporting schedule, perform project updates on timely manner and conduct project management including timeline, budget, compliance, quality, etc.
- Drive and provide strong inputs to the development of clinical study dossiers including but not limited to clinical protocol, Investigator Brochure (IB), Case Report Form (CRF), Informed Consent Form (ICF), etc. with certain support from global R&D
- Screen and oversee external vendors (CRO, SMO, etc.) and clinical sites/investigators. Build and maintain the KOL networks
- Manage clinical contract relevant works, study samples preparation and equipment purchasing. Perform financial tasks including billing, forecasting and pass-through cost management
- Host clinical study meetings with clinical sites/investigators. Develop and deliver training and presentations to external stakeholders
- Support clinical trial filing to authority and Human Genetic Resource Administration approval/filing as necessary
- Monitor and conduct audit to clinical study execution and support NMPA clinical study inspection as appropriate
- Coordinate clinical study report generation and review
- Deeply involve in addressing any issue or query throughout the project implementation
- Drive study management and clinical operational excellence by identifying opportunities, mitigating risks and supporting continuous improvements
- Establish and enforce departmental standard of procedures, tools for project management, etc.
- Collect and analysis regulatory intelligences including new and changing regulations and industry/competitor updates that affect the organization
- As needed, responsible for the search, sorting and clinical evaluation of medical literature related to the products, and provide evidence-based medical evidence for product registration and marketing