Clinical Trials Project Manager

1 week 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 play a critical role in accelerating and synergizing efforts that can quickly transition fundamental immunobiology research into the clinic.

About the Role:

The Sr. Clinical Trials Project Manager will work within the Center for Cellular Immunotherapies Clinical Operations Team, managing and optimizing the clinical research infrastructure necessary for bringing novel/personalized cell and gene therapies to patients.

Key Responsibilities:
  • Support the translation of first-in-human investigational cell and gene therapy products from the bench to bedside.
  • Manage/accelerate the clinical trial development and new study activation pathways.
  • Establish internal and external collaborative partnerships.
  • Establish/maintain the infrastructure required to standardize and optimize clinical trial development and execution; and ensure ongoing oversight/compliance.
  • Develop/refine standardized processes, procedures, and templates/tools to align with the changing regulatory landscape and new scientific innovation.
  • Ensure the generation of high-quality, reliable, and statistically sound clinical data that can be used for reporting, publication, endpoint analysis, and further product development.
  • Identify/implement new technology/systems required to enhance clinical research operations.
Requirements:
  • Ability to manage projects independently.
  • Strong analytical and problem-solving skills.
  • Excellent organizational and time management skills.
  • High attention to detail; demonstrated ability to multi-task.
  • Excellent oral and written communication skills.
Preferred Qualifications:
  • Knowledge of FDA regulations and GCP-ICH guidelines.
  • Comprehensive understanding of clinical trials processes and the conduct of clinical research studies.
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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