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Lead Clinical Trials Coordinator

2 months ago

San Diego, California, United States BioPhase Full time

Senior Clinical Trials Manager

The Senior Clinical Trials Manager at BioPhase plays a crucial role in supervising and implementing the operational elements of clinical research from the development of protocols to the finalization of data. This position ensures 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 for vendors on specific protocols and operational practices.
  • Establish and nurture relationships with Contract Research Organizations (CROs), investigators, and study personnel.
  • Guarantee that clinical studies are executed in compliance with protocols, 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.
  • Assist in the development and preparation of essential study documents 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.