Senior Clinical Trial Manager

Location
Menlo Park, CA, United States
Posted
Feb 03, 2021
Ref
581998969
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Job Description:
    The Senior Clinical Trial Manager (CTM) will manage all clinical aspects of phase 1b-III clinical studies.

Responsibilities:
  • Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements
  • Develop clinical trial protocol synopsis, protocols, amendments and informed consent documents
  • Develop study budget and timelines with clear assumptions
  • Track overall spend for the study over the course of the study
  • Collaborate with Regulatory to prepare regulatory documents for submission to the FDA
  • Maintain Trial Master File with assistance from Clinical Trial Associate
  • Manage Investigational Product (IP)
  • Manage safety reporting to sites and regulatory bodies
  • Procure and manage contracts with CROs, study vendors and investigative sites
  • Provide oversight of CROs, independent field monitors and other clinical vendors
  • Review monitoring trip reports and track resolution of all action items and protocol deviations
  • Co-monitor at investigative sites to evaluate study site and field monitor performance
  • Collaborate with medical experts, clinical study sites, and clinical study vendors
  • Some travel may be required
  • Manage activities assigned to direct reports
  • Provide frequent study updates to senior management upon request

Requirements:
  • Minimum BS / BA (science or healthcare field) or nursing degree
  • Minimum of 6 years of experience in a biotech or pharmaceutical company, leading cross-functional clinical activities

Preferred Skills, Qualifications, or Technical Proficiencies:
  • Attention to detail and ability to prioritize tasks to meet critical deadlines
  • Excellent verbal and written communication skills
  • Able to collaborate effectively with the study team, cross-functional team members, and external partners
  • Knowledge of ICH/GCP and FDA regulations
  • Strong proficiency in Microsoft Office