A startup sized Oncology Biotech located in the Bay Area is looking to bring an experienced Senior Clinical Trial Manager consultant onto its team. The Senior CTM will be focusing on the company's early phase Oncology program, which boasts multiple studies.
Responsibilities will include but are not limited to:
- Planning, executing, management, and oversight of Clinical Trials
- Leading vendor selection/site selection processes
- Oversees creation of study budget, monitoring, recruitment, and timeline plans
- Supervise, oversee, and maintain communication with CRO and other third-party vendors
- Lead the development of study protocols, study SOPs, ICF forms, CRFs, etc.
- Lead a cross-functional team including clinical operations, data management, regulatory affairs, pharmacovigilance, biostatistics, etc.
- Execute clinical studies according to ICH/GCP guidelines, FDA regulations, from startup through closeout
- Keep stakeholders informed of and up to date with study progress/advancement
- Bachelor's degree (life sciences preferred)
- 5+ years Oncology Trial Management experience in an industry setting is REQUIRED
- 5+ years clinical research experience, in an industry setting
- 5+ years Clinical Trial Management experience, in an industry setting
- An understanding of cross-functional clinical processes
- Ability to juggle multiple complex tasks at any given time