Clinical Study Manager

Arthrex Inc

Naples, FL, United States
Not specified; annual bonus available; benefits in...
On-site
Manage clinical research studies from start-up to close-out
Oversee cro activities and vendor onboarding
Ensure compliance with ctms, etmf, and edc systems
The role involves managing clinical research studies from intake through closeout while ensuring strict adherence to GCPs and FDA regulations

Job Summary

  • The role involves managing clinical research studies from intake through closeout while ensuring strict adherence to GCPs and FDA regulations.
  • Candidates will lead contract and budget negotiations, oversee CRO activities, and coordinate site training to ensure successful study execution.
  • Arthrex offers a comprehensive benefits package including medical, dental, vision, matching 401(k), and paid parental leave.

Matching Summary

Match Score: 85

The role involves managing clinical research studies from intake through closeout while ensuring strict adherence to GCPs and FDA regulations.

Salary

Not specified; Annual Bonus available; Benefits include Medical, Dental, Vision, 401(k) match

Skills & Requirements

Must-have

  • Manage clinical research studies from start-up to close-out
  • Oversee CRO activities and vendor onboarding
  • Ensure compliance with CTMS, eTMF, and EDC systems
  • Lead contract and budget negotiations
  • Track study timelines, milestones, and quality metrics

Nice-to-have

  • Experience with pre-market IDE or IND studies
  • Ability to assist in user acceptance testing
  • Strong communication skills for stakeholder updates
  • Proactive risk identification and mitigation

Key Requirements

  • Bachelor's degree in health/life sciences + 4 years experience OR Master's + 5 years
  • Clinical Research Certification required or obtained within one year
  • One year of industry-sponsored or CRO employment required
  • Knowledge of ICH guidelines and FDA Regulations

Work Rights

Not specified

Tailored Resume

Cover Letter