Clinical Study Excellence Specialist

hace 4 semanas


Barcelona, Barcelona, España Mygwork A tiempo completo
Job Title: Clinical Study Excellence Scientist

Bayer UK & Ireland is an inclusive employer and a member of Mygwork, the largest global platform for the LGBTQ+ business community.

Job Summary:

The Clinical Study Excellence Scientist is the point of contact and responsibility for all aspects of a trial within the study team, ensuring the safety of study participants, the quality of data, and the success of the development project.

Key Responsibilities:
  • Primary contact person during the study for protocol and safety questions for one or more trials.
  • Design the medical review strategy and develop the Medical Review Plan.
  • Contribute to the content of sections of clinical study protocol and other study-related documents/publications that require scientific input.
  • Provide medical input at SIV and Investigator Meetings and present the medical background, rationale for the trial, and relevant sections of the protocol.
  • Support the Clinical Lead for the presentation of clinical/safety data to DMC, SCs, internal governance committees, and external consultants.
  • Train or contribute to the training of study team, CRAs/CLMs, site staff, and CRO staff on medical aspects of the study, indication, and compound.
  • Query identifiable safety-related medical discrepancies or requests for clarification in the appropriate EDC and related systems.
  • Coordinate with Clinical Lead to provide consistent replies to health authorities, including local Ethics committees (ECs).
  • Review incoming medical data on both accumulative and individual basis.

Bayer is a visionary company driven to solve the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility.



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