15 days ago
My Client is a leading precision oncology company developing highly targeted cancer therapies. This company is growing at a rapid pace with challenging and exciting opportunities for experienced professionals.
About the Role
We are looking for a Senior Clinical Trial Manager to become part of a fast-based, innovative team committed to developing breakthrough cancer therapies. The successful candidate will be an independent self-starter able to work independently as well as collaboratively.
- Lead cross-functional trial team, manage clinical trials and protocol execution.
- Oversee CROs and vendors to ensure timelines in accordance with SOPs and GCP, all within budget.
- Maintain and TMF throughout the lifecycle of the trial.
- Serve as functional area reviewer of global clinical and regulatory submissions.
- Recommend contingency plans to Head of Clinical Operations as necessary.
- Mentor and train in-house CRAs
- Five years or more of clinical management experience in biotech/pharmaceutical industry or a CRO
- Global Trial and oncology experience highly preferred
- Strong understanding of FDA/ICH guidelines and industry standard practices regarding clinical trial management
- Solid understanding of the clinical trial database life cycle including, CRF design, data collection, review and analysis, CRF design, database development and testing, CRF design, data quality review and database close and lock procedures.