Senior Clinical Data Specialist
1 month ago
About the Role
The Senior Medical Reviewer will be responsible for conducting comprehensive medical reviews of clinical trial data across various therapy areas within the drug development portfolio. This role ensures the highest quality and consistency of medical data, with a strong emphasis on patient safety, protocol adherence, and compliance with Good Clinical Practice (GCP), ICH guidelines, local regulations, and Standard Operating Procedures (SOPs).
Key Responsibilities
- Collaborate closely with study team members—such as Data Managers, Trial Managers, and Medical Specialists—throughout the trial process.
- Provide timely updates on the status of medical reviews.
- Escalate any issues to maintain trial integrity and compliance.
About the Team
The Centralised Monitoring Unit (CMU) is a department within the Clinical Drug Development area. It is a perfect blend of skilled medical professionals and technical programmers. Medical reviewers are actively involved in Risk-based medical monitoring in collaboration with the medical specialists from Denmark, with a focus on ensuring overall patient safety and wellbeing of all clinical trial participants.
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