about 1 year ago
- Responsible for ensuring the Clinical Team delivers timely and high-quality project deliverables.
- Site Management: Track and manage subject recruitment at all study sites. Oversee or supports the management of study Monitoring Visits, and review and approval of Monitoring Reports.
- Study Start-Up: Uses operational and therapeutic expertise to optimize trial execution.
- Document and Supplies Management: Oversee or support the collection, review and filing of site essential documents, and maintenance of the TMF.
- Compliances: Follow international GCP guidelines/regulations, SOPs, and study protocol for executing clinical studies.
- Staff Management: Provides coaching and guidance to junior Clinical staff, and cross-functional working with other departments
- Bachelor's degree in a life science discipline
- 4+ years of Trial Management experience
- Strong experience working on early phase oncology trials
- Knowledge of medical terminology and clinical trial monitoring and management process.
- Strong understanding of ICH GCP and worldwide applicable regulatory requirements
- Document study conduct and management.
- Effective business skills for interactive situations with peers, sites, and clients