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Clinical Trial Operations Manager

2 months ago


Uxbridge, United Kingdom Gilead Sciences Full time
Job Summary

Gilead Sciences is seeking a highly skilled Clinical Trial Manager to join our Late Phase Clinical Operations team. As a key member of our team, you will be responsible for managing Non-Interventional Studies and/or Managed Access Programs across different therapeutic areas and global regions.

Key Responsibilities
  • Study Management: Manage aspects of assigned Global and/or Regional Non-Interventional Studies including regulatory commitments and/or Managed Access Programs within designated study budgets and timelines.
  • Communication: Communicate project status and issues and ensure project team goals are met.
  • Document Development: Contribute to the writing and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring, and other study plans and clinical study reports.
  • Collaboration: Develop good working relationships with global Late Phase operational team and global cross-functional staff including Medical Affairs, Pharmacovigilance, Real World Evidence, Project Management, Regulatory, Clinical Data Science, and Clinical Development as required.
  • Reporting: May participate in the preparation of interim/final clinical study reports.
  • Feasibility Assessment: Conduct study feasibility in conjunction with internal Medical Affairs and/or Real World Evidence and Clinical Operations staff and/or external collaborators or CROs.
  • Expertise: May serve as a resource for others within the company for clinical trials management expertise.
  • Organizational Analysis: Under general supervision, is able to examine functional issues from an organisational perspective.
Requirements
  • Education: Typically requires a BSc in a relevant scientific discipline and relevant clinical experience in the pharmaceutical or healthcare industry or equivalent.
  • Experience: Previous experience in the management of Non-Interventional Studies highly preferential.
  • Regulatory Knowledge: Good knowledge and understanding of ICH GCP, FDA and EMEA regulations and guidelines governing Non-Interventional Studies and/or Managed Access.
  • Initiative: Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
  • Travel: Occasional travel may be required.
Gilead Core Values
  • INTEGRITY: Doing What's Right
  • INCLUSION: Encouraging Diversity
  • TEAMWORK: Working Together
  • EXCELLENCE: Being Your Best
  • ACCOUNTABILITY: Taking Personal Responsibility