Manager Unmasked Drug Oversight

Johnson & Johnson

Beerse, Belgium
**
Unmasked drug oversight management
Investigational product (ip) management
Independent drug monitor (idm) support
** Johnson & Johnson is seeking a Manager Unmasked Drug Oversight to oversee clinical operations related to Investigational Product management across various locations in Europe. The role requires extensive experience in clinical trial operations and a strong understanding of ICH and GCP guidelines, with a focus on leading study teams and ensuring compliance throughout the trial process. **

Job Summary

  • The Manager Unmasked Drug Oversight is responsible for the study and country level management of clinical operation activities related to Investigational Product (IP) management for blinded studies with an unblinded IP component.
  • Responsibilities include overseeing and supporting the Independent Drug Monitor (IDM) with site level activities, monitoring pharmacy compliance, and investigating urgent/critical unblinded and pharmacy-related issues.
  • The role requires a deep understanding of ICH and GCP guidelines, knowledge of systems like RTSM and EDC, and the ability to lead cross-functional teams in a matrix environment.

Matching Summary

Match Score: 75

** Johnson & Johnson is seeking a Manager Unmasked Drug Oversight to oversee clinical operations related to Investigational Product management across various locations in Europe. The role requires extensive experience in clinical trial operations and a strong understanding of ICH and GCP guidelines, with a focus on leading study teams and ensuring compliance throughout the trial process. **

Skills & Requirements

Must-have

  • Unmasked Drug Oversight management
  • Investigational Product (IP) management
  • Independent Drug Monitor (IDM) support
  • ICH and GCP guidelines
  • RTSM System and EDC knowledge

Nice-to-have

  • Innovative spirit and leadership
  • Operational excellence
  • Process improvement activities
  • Global Development Initiatives participation

Key Requirements

  • BS degree or equivalent, related experience
  • Minimum of 8 years of experience
  • Experience with clinical trial related activities at site pharmacy
  • Ability to lead cross-functional team
  • Global experience required

Work Rights

Not specified

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