Head of Clinical Trials Management

3 weeks ago


Philadelphia, Pennsylvania, United States University of Pennsylvania Full time

Job Summary

The University of Pennsylvania seeks a highly skilled and experienced Clinical Trials Project Manager to join our team. As a key member of our Clinical Trials Unit, you will be responsible for managing and overseeing the execution of clinical trials, ensuring compliance with regulatory guidelines and Good Clinical Practice (GCP) principles.

Key Responsibilities

  • Manage and supervise study teams, including developing and driving study timelines and strategies
  • Conduct study-related visits and procedures, including recruitment, as needed to meet the needs of DOM CTU research projects
  • Develop, create, and review regulatory submissions, including protocols, consents, annual reports, unanticipated problems, etc., and address regulatory reviewer inquiries
  • Provide assistance with IND/IDE/CTA exemption determinations
  • Manage study budgets and ensure payments are received and paid out in a timely manner
  • Oversee data and sample management, including compliance checks and helping teams prepare for audits
  • Develop source documents, training slides, manual of procedures, CRFs, and SOPs related to each study

Requirements

  • Bachelor of Science and 3 to 5 years of experience or equivalent combination of education and experience is required
  • Strong planning and organizational capabilities along with attention to detail, excellent follow-through, and problem-solving skills necessary
  • Must be effective in setting and meeting personal short- and long-term goals to complete assignments, with multiple project tasks ongoing simultaneously

What We Offer

The University of Pennsylvania offers a competitive benefits package, including excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.



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