Lead Clinical Study Manager

2 weeks ago


San Diego, California, United States BioPhase Full time

Senior Clinical Trials Manager

The Senior Clinical Trials Manager at BioPhase plays a pivotal role in directing and managing the operational elements of clinical investigations from the initial protocol formulation to the final database closure. This position is crucial in ensuring that studies are conducted promptly and in accordance with established protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements.

Key Responsibilities:

  • Facilitate training sessions for vendors on study protocols and operational practices.
  • Foster and maintain strong partnerships with Contract Research Organizations (CROs), investigators, and study personnel.
  • Guarantee that clinical studies are executed in compliance with the study protocol, SOPs, and applicable regulations.
  • Oversee the management of investigational products and ensure accountability for study medications.
  • Analyze study quality metrics and implement necessary corrective actions.
  • Contribute to the development and preparation of essential study documentation and protocols.

Qualifications:

  • Bachelor's degree in life sciences or equivalent professional experience.
  • Preferred therapeutic experience in the field of autoimmunity.
  • A minimum of five years of experience in managing clinical trials.
  • Comprehensive understanding of clinical research principles and FDA regulations.
  • Excellent communication skills and the ability to thrive in a dynamic work environment.


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