Clinical Trial Manager

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

Summary:

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