Clinical Study Lead

3 weeks ago


Reston, Virginia, United States EPM Scientific Full time

About EPM Scientific

EPM Scientific is a global pharmaceutical company with a strong track record of innovation and growth. We are seeking a highly motivated and experienced Clinical Study Lead to join our team in a hybrid role.

Job Summary

The Clinical Study Lead will be responsible for leading in-house study activities for a large global Phase 3 study. This includes mentoring junior team members, overseeing the set-up and maintenance of study systems, and reporting to the Clinical Program Lead.

Key Responsibilities

  • Lead in-house study activities for a large global Phase 3 study
  • Mentor junior team members to ensure their growth and development
  • 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 on study progress and performance
  • May be responsible for managing CRA and CTA teams as direct reports

Requirements

  • 5+ years of experience in the pharmaceutical industry, with a focus on clinical research and development
  • 3+ years of experience in on-site monitoring, with a strong understanding of ICH GCP guidelines
  • 2+ years of experience leading studies or trials in-house, with a focus on rare diseases 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 career growth and development
  • A dynamic and supportive work environment
  • Access to cutting-edge technology and resources

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