Clinical Quality Compliance Specialist
On-siteReading, England, United Kingdom
Job Summary
Design and analyze clinical trials by interpreting complex medical data to ensure compliance with regulatory requirements, industry standards, and company policies. Conduct quality reviews of clinical trial documentation, protocols, and study reports to identify areas for improvement, while participating in internal and external audits to support preparation, documentation, and response activities. Collaborate with cross-functional teams to address quality issues, implement corrective and preventive actions, and provide guidance to colleagues on quality compliance matters. This role requires a Bachelor's degree in a relevant scientific discipline, experience in clinical quality assurance, and knowledge of FDA/EMA regulations and ICH-GCP guidelines. Approximately 65% travel is required.
Required Qualifications
- Bachelor's degree or higher in a relevant scientific discipline or healthcare-related field
- Previous experience in clinical quality assurance or compliance within the pharmaceutical, biotechnology, or CRO industry
- Knowledge of regulatory requirements, including FDA/EMA regulations, ICH-GCP guidelines, and ISO standards
- Strong attention to detail and analytical skills, with the ability to review and interpret complex documentation and data
- Excellent communication, organizational, and problem-solving skills, with the ability to work effectively in a team environment
- Willingness to travel as required (approximately 65%)
- Employment with ICON is contingent upon having the legal right to work in the country where the role is based
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