Senior Clinical Data Manager/Principal Clinical Data Manager

hace 1 día


Alcobendas, Madrid, España Precision Medicine Group A tiempo completo
Job Summary

The Senior Clinical Data Manager/Principal Clinical Data Manager will oversee all aspects of the clinical trial data management process from study start-up to post database lock for assigned projects. This role is responsible for ensuring compliance with Standard Operating Procedures, regulatory directives, and study-specific plans.

Key Responsibilities
  1. Lead the data management team for assigned clinical projects, ensuring timely and high-quality delivery of data management tasks.
  2. Develop and maintain data entry guidelines, train data entry personnel, and oversee data entry quality.
  3. Conduct quality control of data entry and ensure that clinical data management deadlines are met.
  4. Assess resource needs for assigned projects and provide input on project timelines.
  5. Develop CRF specifications from the clinical study protocol and coordinate review/feedback from stakeholders.
  6. Build and maintain clinical databases, conduct database build UAT, and ensure quality-controlled database build documentation.
  7. Specify requirements for edit check types and oversee development of edit check specifications.
  8. Create, revise, and maintain data management documentation and ensure completeness of data management documentation for the Trial Master File.
  9. Train clinical research personnel on study-specific CRF, EDC, and other project-related items.
About Precision Medicine Group

Precision Medicine Group is a leading provider of clinical data management services. We are committed to delivering high-quality data management solutions that meet the needs of our clients.



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