CRA Manager responsible for oversight, coaching, and performance management of CRA teams to meet clinical trial KPIs. Focused on delivery, quality, and compliance for clinical research in China.
About the role
- Senior Scientist leading planning and execution of clinical trials at a healthcare company. Engaging cross-functional teams to ensure quality and integrity in clinical research.
Responsibilities
- Lead the scientific planning and execution of one or more clinical trials or significant aspects thereof
- Serve as the lead clinical scientist on the clinical trial team
- Lead medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the Clinical Director
- Collaborate cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments)
- Provide tactical/scientific mentorship to other clinical scientists
Requirements
- Bachelor's degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR master's degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD degree
- Degree in life sciences, preferred
- Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions
- Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
- Experience in conducting global clinical trials, including trial initiation through database lock
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays, vacation, and compassionate and sick days
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