8+ years pharmaceutical drug development experience
1-2 years lead cra coordinating international studies
3+ years field cra monitor experience
This role involves coordinating clinical monitoring activities across assigned international Phase studies while overseeing CRO site management
Job Summary
This role involves coordinating clinical monitoring activities across assigned international Phase studies while overseeing CRO site management.
The position requires ensuring all activities are executed in compliance with regulatory requirements, Good Clinical Practice guidelines, and internal SOPs.
Ipsen offers a comprehensive benefits package including 401(k) contributions, medical coverage, and paid time off alongside the base salary range.
Matching Summary
This role involves coordinating clinical monitoring activities across assigned international Phase studies while overseeing CRO site management.
Salary
Base: $112,500-$165,000; Bonus/Equity: Eligible for short-term incentives; Benefits: 401(k), medical, dental, vision, life insurance, parental leave
Skills & Requirements
Must-have
8+ years pharmaceutical drug development experience
1-2 years Lead CRA coordinating international studies
3+ years Field CRA monitor experience
Experience managing Contract Research Organizations
Knowledge of GCP ICH regulations and QMS
Proficiency in CTMS and clinical data systems
Nice-to-have
Experience in Oncology Rare Disease or Neuroscience
Background with radiopharmaceutical compounds
Strong coaching and interpersonal skills
Proactive hands-on approach to problem solving
Experience with audit preparation and inspection support
Key Requirements
Minimum 8 years relevant experience in pharmaceutical drug development
Minimum 1 year as Lead CRA for international registrational studies
At least 3 years experience as a Field CRA monitor
Degree in life sciences medicine or relevant field
Clinical Research Associate qualification required