Clinical Trials Project Manager

Location
San Diego,CA
Posted
May 10, 2018
Required Education
Bachelors Degree
Position Type
Full time

Description

This position is responsible, within the rapidly expanding AnaptysBio clinical portfolio, for contributing to the management of clinical research programs. Duties may involve contributions to multiple  clinical studies of differing phases, to include project planning, budgeting, resource management, preparing and negotiating Clinical Trial Agreements, participating in the selection and management of study vendors, organizing and conducting Investigator Meetings and making clinical presentations, etc. The successful candidate will be part of the growing clinical operation team and  will work in close collaboration and liaise with all the developmental functions involved in the progression of the AnaptysBio clinical programs.

Requirements

  • BA/BS in a related scientific or healthcare field 
  • 6+ years of clinical operations experience gained working in a pharmaceutical/biotechnology industry environment, with a strong preference for immunology and antibody/biologics experience; CCRA preferred.
  • Proven ability to plan, conduct and manage clinical operations from pre-clinical through early phase trials, with additional experience in later phases preferable.
  • Demonstrated ability to manage CROs, central laboratories, and other clinical study vendors.
  • Previous experience negotiating vendor/site contracts and fiscal management thereof.
  • Ability to write and edit protocols and other project-related documents, clinical study reports and summary documents for regulatory submissions.