Senior Clinical Project Manager

System One Holdings, LLC

• $110K — $130K *
Exton, PA 19341In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree required; scientific background preferred
  • 10+ years of experience in clinical research
  • Experience with medical device research, especially regulated projects
  • Strong understanding of clinical research processes and vendor management
  • Experience managing budgets and performing quality audits
  • Experience setting up clinical sites is important
  • Ability to manage complex projects and lead cross-functional teams

Responsibilities

  • Lead and manage complex studies from start-up to close-out
  • Drive budget management while leading complex projects
  • Perform vendor management and serve as the dotted line manager for CRAs and a junior PM
  • Ensure compliance with regulated project requirements, including pre-market IDE experience
  • Set up and add several new sites over the next few years
  • Complete medical writing study reports and perform quality audits

Benefits

  • Health and welfare benefits coverage options including medical, dental, and vision
  • Spending accounts
  • Life insurance and voluntary plans
  • Participation in a 401(k) plan
Full Job Description
Job Title: Senior Clinical Project Manager
Location: Remote
Type: Direct Hire
Hours: 40.0 hours per week

Overview
Seeking a highly organized and communicative Senior Clinical Project Manager to lead complex clinical studies, manage vendor relationships, and ensure regulatory compliance. The role involves setting up new clinical sites, overseeing project budgets, and delivering high-quality study reports. Ideal candidates will have extensive experience in regulated clinical research and proven leadership capabilities.

Responsibilities

  • Lead and manage complex studies from start-up to close-out
  • Drive budget management while leading complex projects
  • Perform vendor management and serve as the dotted line manager for CRAs and a junior PM
  • Ensure compliance with regulated project requirements, including pre-market IDE experience
  • Set up and add several new sites over the next few years
  • Complete medical writing study reports and perform quality audits


Requirements

  • Bachelor's degree required; scientific background preferred
  • 10+ years of experience in clinical research
  • Experience with medical device research, especially regulated projects
  • Strong understanding of clinical research processes and vendor management
  • Experience managing budgets and performing quality audits
  • Experience setting up clinical sites is important
  • Ability to manage complex projects and lead cross-functional teams


System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

#M-
#LI-

Ref: #
568-Clinical

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