Project Manager – Clinical Affairs Management
- Prepare, manage, execute and follow up on clinical-trial projects according to the related standards and timelines;
- Assist withcontract preparation, negotiation, signing and revision;
- Lead the project team members (internal and external) to complete the start-up, implementation and completion of clinical trials on schedule, and conduct overall quality control and management of the clinical trials project in strict compliance with clinical trial protocols and related regulations;
- Standardize the implementation and management of clinical trials to meet the requirement for new drug registration and approval;
- Manage the clinical trial routines, including but not limited to, the selection of both internal and external partners, the management and coordination of suppliers/CROs(outsourcers), and the training and management of CROs and external partners;
- Coordinate the clinical trial drug supply and clinical trial material supply effectively to meet the research requirement;
- Maintain timely communication with other departments to ensure the information related to the clinical trial project is effectively delivered and clinical trials are completed as planned;
- Other tasks as assigned by the manager.
- More than 5 years experience in the pharmaceutical industry, at least 3 years experience in managing clinical trial projects;
- Bachelor’s degree or above, major in medical or biology;
- Familiar with medical terms, physiological terms, pharmacological terms and related rules and regulations;
- Excellent in both English and Chinese;
- Proficient at internal and external communications, detail oriented, positive attitude and able to undertake a variety of tasks in a fast-paced startup environment.
- Discuss the study protocol with the investigators;
- Review and approve patient enrollment;
- Review protocol compliance and manage protocol deviation;
- Study medical data review;
- Review and follow up serious adverse event;
- Manage queries from the clinical site staff;
- Provide medical opinion/review in the clinical study reports;
- Draft clinical studies summary and overview.
- Bachelor degree in clinical medicine and MD/PhD preferred;
- At least 5+ year working experience in clinical medicine;
- At least 5+ years working experience in clinical development function of global biopharmaceutical industry preferred;
- Strong leadership, excellent communication and project management skills;
- Excellent in both English and Chinese.