Clinical Study Lead

3 weeks ago


San Francisco, California, United States EPM Scientific - Phaidon International Full time
About the Role

We are seeking a highly motivated and experienced Clinical Study Lead to join our team at EPM Scientific - Phaidon International. As a Clinical Study Lead, you will be responsible for leading in-house study activities for a large global Phase 3 study, mentoring junior team members, and overseeing the set-up and maintenance of study systems.

Key Responsibilities
  • Lead in-house study activities for a large global Phase 3 study, ensuring timely and successful completion.
  • Mentor and develop junior team members, providing guidance and support to enhance their skills and knowledge.
  • Oversee the set-up and maintenance of study systems, including Clinical Trial Management System (CTMS), Trial Master File (TMF), and study SharePoint.
  • Report to the Clinical Program Lead, providing regular updates and insights on study progress.
  • Manage and develop direct reports, including CRA and CTA teams, to ensure seamless study execution.
Requirements
  • 5+ years of experience in the pharmaceutical industry, with a focus on clinical research and development.
  • 3+ years of on-site monitoring experience, with a strong understanding of ICH GCP guidelines.
  • 2+ years of experience leading studies or trials in-house, preferably in rare disease or dermatology.
  • At least 2 years of experience managing direct reports or mentoring junior clinical operations team members.
  • A Bachelor's degree in Biological Sciences, Nursing, Pharmacy, or a related discipline.
What We Offer
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development in a dynamic and innovative company.
  • A collaborative and supportive work environment, with a focus on teamwork and excellence.
  • Access to cutting-edge technology and resources, enabling you to stay ahead of the curve in clinical research.

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