Posted to MedZilla on 1/17/2020

EPM Scientific

US-CA, Contract Clinical Trial Manager 452431256069-MZ


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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