Clinical Trial Quality Manager

20 hours ago

Dublin, Dublin City, Ireland beBeeRiskManagement Full time €60,000 - €86,000
Job Description

The primary objective of the Risk Surveillance Lead is to drive the adoption of risk-based quality management practices at the trial level.

This role requires strong leadership skills, with a focus on influencing and enhancing clinical trial quality through expert understanding of protocols, processes, regulatory requirements, and quality management principles.

The Risk Surveillance Lead will oversee the implementation and continuous improvement of RBQM practices across assigned trials and programs, ensuring comprehensive clinical quality (GCP) risk governance.

Key responsibilities include facilitating trial protocol risk assessments, drafting and maintaining study-specific documentation, partnering with the RBQM system configuration team, conducting periodic central surveillance, and facilitating risk review meetings.

The ideal candidate will have a bachelor's degree in a health-related or life sciences field, with a minimum of 4 years of experience in the pharmaceutical or CRO industry.

Preferred qualifications include experience in risk-based quality management, robust understanding of drug development and clinical trial execution, knowledge of regulatory standards including 21 CFR Part 11, ICH E6, and ICH E8 (GCP).

Required Skills and Qualifications
  • Bachelor's Degree in a health-related or life sciences field
  • Minimum of 4 years of experience in the pharmaceutical or CRO industry
  • Preferred minimum of 1 year of experience in Risk-Based Quality Management
Benefits

As a Risk Surveillance Lead, you will have the opportunity to work in a dynamic environment with a talented team of professionals. You will be responsible for driving the adoption of RBQM practices, which will enable comprehensive clinical quality (GCP) risk governance.

Others

For consideration, please submit your application, including your resume and cover letter. We look forward to hearing from you

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