Clinical Trials Quality & Risk Leader

Parexel; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Parexel is seeking a senior clinical research professional to strengthen quality and risk management across multiple projects. You will lead CAPA development, root-cause analyses, and ensure ICH-GCP compliance while mentoring teams and contributing to SOP updates.

Ideal candidates have 8–12 years in clinical research, fluency in English, and a life sciences background, with advanced degrees preferred. This role emphasizes leadership and cross-project accountability.

Qualifications

• 8-12 years’ experience in clinical research.
• Demonstrated experience in Quality or Risk Management activities.
• Expertise in CAPA development.
• Proven leadership in mentoring teams and managing complex, multi-project accounts.
• Comprehensive mastery of ICH-GCP principles and their strategic application.
• Fluency in written and oral English; additional languages an asset.
• Support of functional SOP updates and participation in general Quality-related initiatives
• Bachelor’s Degree required preferably in life sciences or health-related discipline or equivalent experience.
• Advanced degree (master’s degree) strongly preferred.

Responsibilities

• Oversee quality and risk management activities across clinical projects.
• Lead CAPA development and root-cause analyses.
• Mentor teams and manage multi-project accounts.
• Ensure compliance with ICH-GCP principles and SOPs.
• Contribute to quality initiatives and SOP updates.

Skills

Quality Management

Risk Management

CAPA Development

Root Cause Analysis

Leadership mentoring

ICH-GCP knowledge

English Fluency

Education

Bachelor's Degree in Life Sciences

Master’s Degree preferred

Job description

Parexel is seeking a senior clinical research professional to strengthen quality and risk management across multiple projects. You will lead CAPA development, root-cause analyses, and ensure ICH-GCP compliance while mentoring teams and contributing to SOP updates.

Ideal candidates have 8–12 years in clinical research, fluency in English, and a life sciences background, with advanced degrees preferred. This role emphasizes leadership and cross-project accountability.