Clinical Trial Manager

2 weeks ago


Eastern Ontario, Canada EPM Scientific - Phaidon International Full time

Clinical Trial Manager/Senior Clinical Trial Manager

Bay Area (Hybrid in South San Francisco)

We're working with a fast growing biotech working in multiple therapeutic areas in phases I-III across six clinical trials.

Position Overview:

This biotech is looking for a Senior / Clinical Trial Manager who will play a pivotal role in driving and managing their ongoing clinical trials and ensuring the success of them. They have an unmatched management team and foster a collaborative work environment.

We've worked with their team for 5+ years and the management team values EPM's candidate submissions as we've placed multiple people with them previously.

Responsibilities:

  • Collaborate with our clinical operations team to oversee clinical trials
  • Shared responsibility for monitoring overall study integrity, interpreting accumulating data on the safety and efficacy, and ensuring compliance with regulatory requirements in global drug development.
  • Interact with our CRO, Clinical Trial Manager, and Project Manager, serving as the lead contact
  • Play a key role in maintaining adherence to Good Clinical Practices, pharmacovigilance standards, and all other quality standards throughout the research process
  • Actively participate in weekly CRO/Internal team communications, contributing to progress reports and discussions on project risks and strategies.
  • Maintain a relationship with CRO Executive Team and other vendors as needed

Experience:

  • Bachelor's Degree; an advanced degree in a scientific field is considered advantageous.
  • Must have at least 3-4 years' experience in managing clinical operations trials
  • Ophthalmology, rare disease, or immunology experience
  • Early phase clinical trial management background
  • Knowledge of GCPs, ICH guidelines and FDA regulations
  • Solid understanding of clinical indications and the drug development process.

Benefits:

  • Competitive salary
  • Notable leadership and growth opportunities
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