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Medical Consistency Expert

2 tygodni temu


Warszawa, Mazovia, Polska GlaxoSmithKline Pełny etat

Our Vision

We envision a future where everyone has access to quality healthcare, and we're committed to making it a reality. As a Director, Medical Review Scientist, you'll play a crucial role in helping us achieve this vision.

Key Responsibilities

  1. Medical Review Activities
  • Perform medical review activities across multiple oncology studies with a wide range of therapeutic modalities and tumor types.
  • Mentor Associate Director MR Scientists and collaborate with fellow Oncology Clinical Development staff from a centralized work location.
Study-Related Documents
  • Review and contribute to study-related documents such as protocols, medical monitoring plans, statistical analysis plans, data management plan, eCRFs, eCRF completion guidelines, database edit checks, risk-based monitoring plans, etc.
  • Contribute to site training activities and supporting the study team and CRO personnel regarding all MR-related aspects of the trial.
Risk-Based Monitoring Plans
  • Collaborate with the Data Management and Clinical Development team to identify program, trial or data risks, creates, and implements mitigation strategies.
eCRFs and Completion Guidelines
  • Supports the Data Management team in ensuring the eCRFs and eCRF completion guidelines accurately reflect the patient population under study and the scope of the protocol.
Clinical Development Team
  • Requires a close collaboration with the study's Clinical Development team (i.e., Study Physician, Clinical Scientist) as well as Patient Safety to discuss/review complex medical questions and concepts.