Job Description

Typical Accountabilities:

  • Ensure successful conduct and integrity of all in-scope clinical studies (, providing medical monitoring)
  • Co-owners of clinical study delivery (with Stats and Clinical Operations)
  • Development documents (CIB, protocol and CSR, ETC) content owner
  • Analysis and interpretation of clinical study results in partnership with BIS, Clinical Operations and Safety (as well as Clinical Pharmacologist If necessary)
  • Forming and running advisory board for portfolio projects; Be responsible for interacting and communicating with China KOLs for China development strategy and protocol design
  • Liaise with safety physician for program-level assessment of safety information, evaluation of safety signals, regulatory compliance of safety reporting Liaise with clinical pharmacologist on PK/PD programs to ensure the deliverables
  • Protocol development preparation for review by the Clinical Challenge and Protocol Review Commi...

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