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Clinical Trial Operations Manager
2 months ago
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.
- 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.
- INTEGRITY: Doing What's Right
- INCLUSION: Encouraging Diversity
- TEAMWORK: Working Together
- EXCELLENCE: Being Your Best
- ACCOUNTABILITY: Taking Personal Responsibility