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Manager, External Clinical Data Services - Remote

Posted 4 days ago
All others
Full Time
USA
$113,100.00 - $184,700.00/year

Overview

The Manager Clinical Data Services will oversee the development of external DTS templates in compliance with CDISC requirements, ensuring alignment with external data vendors and research partners.

In Short

  • Lead the development of DTS documents.
  • Ensure compliance with Data Transfer Specification templates.
  • Respond to queries from data providers and stakeholders.
  • Track DTS status across data types and programs.
  • Provide oversight to external data vendors.
  • Mentor junior staff members.
  • Develop and deliver training on DTS.
  • Contribute to the development of SOPs and guidance manuals.
  • Process change requests for DTS updates.
  • Recommend improvements in External Data Services processes.

Requirements

  • Minimum of 7+ years in External Clinical Data Management.
  • Strong knowledge of database structures in the biotech or pharmaceutical industry.
  • Bachelor’s degree in Science, Health, Computing, or related field.
  • Experience with STDM and External Vendors.
  • Clinical Data Services experience.

Benefits

  • Comprehensive health and wellness programs.
  • Fitness centers.
  • Equity awards.
  • Annual bonuses.
  • Paid time off for eligible employees.

R.F.S

Regeneron France SAS

Regeneron Italy S.r.l is a leading biotechnology company dedicated to inventing life-transforming medicines for individuals with serious diseases. With over 30 years of experience, the company is driven by physician-scientists who excel in translating scientific discoveries into effective medical treatments. Regeneron has developed nine FDA-approved therapies and continues to advance a robust pipeline targeting various health issues, including eye diseases, cancer, and rare diseases. The company fosters a culture of innovation and collaboration, recognized as a Great Place to Work and awarded for its commitment to workplace excellence. Regeneron is committed to improving patient outcomes and providing comprehensive benefits to its employees, promoting an inclusive and diverse work environment.

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