Senior Clinical Trial Project Manager

2 days ago


Philadelphia, Pennsylvania, United States Perelman School of Medicine University of Pennsylvania Full time
Job Summary

We are seeking a highly skilled and experienced Senior Clinical Trial Project Manager to join our team at the Perelman School of Medicine University of Pennsylvania. The successful candidate will be responsible for managing clinical projects and programs, including deliverables from all functional areas and vendors, in accordance with contractual timelines and sponsor specifications.

Key Responsibilities
  • Develop and implement project management plans, defining timelines, milestones, and limitations to project staff and study sites.
  • Monitor project status and timelines, ensuring timely completion of deliverables.
  • Manage clinical projects/programs, including coordination with the clinical team, authoring manual of procedures, and attending trial-kick-off meetings.
  • Establish project metrics and schedules with client representatives, providing regular project updates.
  • Facilitate case report form development, review, approval, and finalization with the Data Management Team.
  • Develop and provide study and/or protocol amendment training to sites.
  • Manage/maintain the Sponsor Trial Master Files for each project/site.
  • Participate in SOP development.
Requirements
  • Bachelor's Degree with 5-7 years of related experience or equivalent combination of education and experience.
  • Knowledge of FDA regulations and GCP-ICH guidelines.
  • Comprehensive understanding of clinical trials processes and the conduct of clinical research studies.
  • Previous Project Management experience strongly recommended.
What We Offer

We offer a competitive salary range of $80,000-$85,000, based on education and experience, as well as a comprehensive benefits package, including health, life, and flexible spending accounts, tuition assistance, retirement plans, and more.

How to Apply

Interested candidates should submit their application, including a cover letter and resume, to [insert contact information].



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