본문
[직무]
- Manage multi-disciplinary clinical trial teams to ensure all trial deliverables are met according to timelines, budgets, quality, and operational procedures. Manage clinical trial meetings, report study progress and issues, and provide resolution and action plans if necessary.
- Accountable for clinical trial protocols and related documents. Contribute to the development/review of study related documents, plans, and processes. Prepare/review training materials and presentations related to the planning and conduct of the trial(s).
- Accountable for the development, management, and forecast of study budgets/invoices
- Responsible for managing CRO(s) and vendors to ensure adherence to scope of work within timelines and budget.
- Ensure ongoing medical/scientific review, final analysis, and interpretation including the development of clinical trial reports, publications, and internal/external presentations.
- Responsible for the development of clinical sections of regulatory documents like IB, briefing books, safety updates, IND/NDA submission documents, and responses to Health Authority questions.
- Demonstrate understanding of the drug development process and provide scientific feedback on due diligence activities
- Manage resolution of trial operational issues, provide updates on trial progress, and mentor/provide guidance to team members
- Review Site visit reports, take actions within the timeline specified and escalate issues and ensure appropriate documentation of issues |
[자격]
- 학력 : 학사 이상
- 전공 : Pharmacology, pharmaceutical science, and life sciences. Preferring Masters or Doctorate degrees
- Thorough knowledge of GCPs, clinical trial design, regulatory processes, and global clinical development process
- English proficiency (written and verbal) |
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