Clinical Trials Project Manager

2 days ago


Philadelphia, Pennsylvania, United States University of Pennsylvania Full time
Job Title: Sr. Clinical Trial Project Manager

Join the University of Pennsylvania's Perelman School of Medicine as a Sr. Clinical Trial Project Manager and contribute to the advancement of medical research and education.

Job Summary:

The Sr. Clinical Trial Project Manager will oversee the management of Phase I Penn-sponsored clinical research studies, ensuring the successful execution and implementation of projects from start-up to close-out. This role requires strong analytical and problem-solving skills, excellent organizational and time management skills, and the ability to manage multiple tasks simultaneously.

Key Responsibilities:
  • Manage and execute all study start-up activities, including coordinating and hosting site initiation visits (SIVs)
  • Establish and maintain the Sponsor Trial Master File (TMF)
  • Coordinate and manage Data and Safety Monitoring Board (DSMB) activities, including development and maintenance of required documentation and adherence to the DSMB Charter
  • Qualify and oversee third-party sponsor vendors as applicable
  • Work collaboratively with the Data Management team to develop a compliant study database and supportive data management documentation
  • Provide seamless oversight of ongoing study activities and support site management activities
  • Facilitate required updates and reporting to sponsor teams and third-party collaborators, ensuring adherence to data sharing and reporting requirements in contractual agreements
  • Support sponsor regulatory reporting requirements and work collaboratively with the monitoring team to manage compliance concerns and execute training
Requirements:
  • Bachelor's degree with 5-7 years of related experience or an equivalent combination of education and experience
  • Knowledge of FDA regulations and GCP-ICH guidelines, as well as a comprehensive understanding of clinical trials processes and the conduct of clinical research studies
  • Previous project management experience is strongly recommended
  • Ability to manage projects independently, with strong analytical and problem-solving skills, excellent organizational and time management skills, and the ability to manage multiple tasks 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.

This position is eligible for a hybrid work schedule with a work week divided between working onsite and working remotely.



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