Clinical Monitoring Lead

IPSEN

Cambridge, US
Base: $112,500-$165,000; bonus/equity: eligible fo...
Clinical monitoring activities coordination
Oversee cro clinical management
Ensure gcp compliance
As Clinical Monitoring Lead, you will be responsible for coordinating clinical monitoring activities across assigned international Phase studies, overseeing CRO clinical and site management activities, and ensuring compliance with regulatory requirements

Job Summary

  • As Clinical Monitoring Lead, you will be responsible for coordinating clinical monitoring activities across assigned international Phase studies, overseeing CRO clinical and site management activities, and ensuring compliance with regulatory requirements.
  • Your focus will be on ensuring timely delivery and budget adherence to support the successful execution of Clinical Development objectives and uphold the highest standards of clinical excellence.
  • Ipsen offers a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, and parental leave.

Matching Summary

As Clinical Monitoring Lead, you will be responsible for coordinating clinical monitoring activities across assigned international Phase studies, overseeing CRO clinical and site management activities, and ensuring compliance with regulatory requirements.

Salary

Base: $112,500-$165,000; Bonus/Equity: eligible for short-term incentives; Benefits: comprehensive benefits package

Skills & Requirements

Must-have

  • Clinical monitoring activities coordination
  • Oversee CRO clinical management
  • Ensure GCP compliance
  • Study start-up oversight
  • CRO relationship management
  • Clinical study data reviews

Nice-to-have

  • Human-centric leadership
  • Collaboration and excellence
  • Empowered and thriving workplace
  • Continuous learning and improvement

Key Requirements

  • 8+ years relevant experience in pharmaceutical drug development
  • Minimum 1 year as Lead CRA
  • At least 3 years experience as Field CRA monitor
  • Experience managing CRO relationships
  • Excellent knowledge of GCP and ICH regulations
  • Degree in life sciences or relevant field
  • Clinical Research Associate (CRA) qualification

Work Rights

Not specified

Tailored Resume

Cover Letter