Senior Manager, Clinical Operations

2 weeks ago

Dublin, Dublin City, Ireland beBeeClinical Full time $132,400 - $216,000
Clinical Trials Management ProfessionalAdvancing Capabilities in Document and Process Management

The primary responsibility of this role involves closely managing the Clinical Trial Management System (CTMS) to advance Regeneron's document and process management capabilities.

Key Responsibilities:
  • Define business requirements associated with clinical trial data within CTMS, ensuring quality, completeness, and timeliness.
  • Collaborate with cross-functional teams to gather feedback and identify valuable improvements that align with long-term goals.
  • Drive continuous improvement by proactively shaping CTMS strategies to align with evolving industry standards and regulations.
Requirements:
  • Relevant experience with Clinical Trials, documents, and responsibilities internal and external to the Sponsor is essential.
  • Subject Matter Expertise in CTMS, TMF, and Organization/Person Profile Management is required.
  • Ability to communicate complex issues to internal and external partners driving effective decision-making is necessary.

This role requires a minimum of a bachelor's degree with 8+ years relevant experience.

Tech & Process Enhancement:
  • Audit and analyze system performance, identifying areas for improvement.
  • Maintain awareness of industry trends and best practices, positioning Regeneron as a frontrunner in technological applications in clinical operations.
Leadership & Team Collaboration:
  • Lead and support CTMS related meetings including Superuser and Operational Working Group.
  • Present to the Regeneron Steering Committee and request endorsement of system enhancements, as needed.

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