Role: Contract Clinical Trial Manager
Duration: 6-8 Month Contract
Therapeutic Area: Oncology
Location: Redwood City, CA
A rapidly progressing Biotech Company in Redwood City, CA is in immediate need of a Contract Clinical Trial Manager. This is a 6-8 Month contract focused on an Oncology project and requires 40 hours a week office-based.
Job Responsibilities of the Contract CTM:
- Responsible for the preparation and finalization of project and study-related documents including: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required
- Coordinates the design, format and content of CRFs, study guides, study reference binders, patient diaries
- Responsible for the preparation of study budgets and timelines
- Manages project timelines and vendor performance to meet departmental and corporate goals
- Manages study budget and payment process for all clinical trial vendors including investigative sites
- Hires, trains and oversees study Field Monitors (e.g., review of all trip reports) and provide guidance on site issues
Requirements of the Contract CTM:
- Knowledge of ICH/GCP Guidelines and FDA Regulations
- Oncology/Hematology Experience a BONUS
- Strong interpersonal and skills and written/verbal communication skills
- Problem Solving Skills
- Close attention to detail
- Phase III experience is a BONUS
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