Manager Unmasked Drug Oversight

Johnson & Johnson Innovative Medicine

Beerse, Belgium
Hybrid
Unmasked drug oversight
Investigational product management
Clinical trial project management
Johnson & Johnson Innovative Medicine is seeking a Manager Unmasked Drug Oversight to oversee clinical operation activities related to Investigational Product (IP) management across various locations in Europe. The role requires significant experience in clinical trial operations, particularly in pharmacy-related activities, and offers an opportunity to lead cross-functional teams while ensuring compliance and quality in clinical trials

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 inhouse and outsourced, blinded studies that have an unblinded IP component.
  • Responsibilities include creating of and/or, contributing to development of study procedural documents and system development, overseeing and supporting the Independent Drug Monitor (IDM) with site level activities.
  • The role requires a BS degree or equivalent with preferably 8 years of experience in clinical trial operations or pharmacy industry, with a deep understanding of ICH and GCP guidelines.

Matching Summary

Match Score: 85

Johnson & Johnson Innovative Medicine is seeking a Manager Unmasked Drug Oversight to oversee clinical operation activities related to Investigational Product (IP) management across various locations in Europe. The role requires significant experience in clinical trial operations, particularly in pharmacy-related activities, and offers an opportunity to lead cross-functional teams while ensuring compliance and quality in clinical trials.

Skills & Requirements

Must-have

  • Unmasked Drug Oversight
  • Investigational Product management
  • Clinical Trial Project Management
  • RTSM System and EDC
  • ICH and GCP guidelines

Nice-to-have

  • Innovative spirit
  • Organizational awareness
  • Flexible mindset
  • Cross-functional team leadership

Key Requirements

  • BS degree or equivalent, related experience required
  • Minimum of 8 years of experience in clinical trial operations
  • Experience with clinical trial related activities at the site pharmacy
  • Deep understanding of ICH and GCP guidelines
  • Ability to lead cross-functional team in matrix environment
  • Global experience is required

Work Rights

Not specified

Tailored Resume

Cover Letter