Clinical Trial Manager

Newark, CA
Sep 25, 2018
Required Education
Bachelors Degree
Position Type
Full time


Oversee the conduct of all clinical studies performed and ensure studies are completed on time within budget and in compliance with SOPs, FDA regulations and ICH/GCP guideline.  

Essential Functions and Job Responsibilities:

  • Implement and execute clinical programs, including development and administration of site budgets
  • Assist in the writing of protocols, the design of case report forms and other study documents and forms
  • Work closely with external site monitors to oversee all aspects of clinical trial
  • Evaluate, tabulate and may prepare written summaries of clinical data
  • Ensure compliance with protocol, overall clinical objectives and FDA requirements
  • Conduct review and source verification of clinical data and ensure timely resolution of data queries
  • Maintain contact with clinical investigators and staff
  • Primary interface with CRO
  • Manages communications between monitors and clinical sites and CRO
  • Tracks all required site documentation
  • Complete other responsibilities as assigned

Minimum Qualifications:

  • Requires a BS, MS or equivalent in life sciences, or related technical degree with 8+ years of experience
  • Experience managing multi-site trials
  • Experience in Clinical Trial Management, specifically demonstrating application of research methodology in a phase 1 and phase 2 clinical setting
  • Thorough knowledge of GCP requirement
  • Excellent written and oral communication skills and ability to operate well in a team environment