Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Clinical Compliance Manager - Make an Impact at the Forefront of Innovation
The Clinical Compliance Manager is responsible for the assessment, management, and reporting of serious breaches of GCP and protocol in clinical trials. This role ensures timely escalation, root cause analysis, regulatory communication, and CAPA tracking in alignment with global regulatory requirements (e.g., EMA, MHRA, FDA). The ideal candidate will serve as a subject matter authority on potential serious breach handling and support other activities related to QA across the clinical development portfolio.

What You'll Do:
•\tLead the assessment and classification of serious breaches in collaboration with QA, Clinical Operations, and Regulatory Affairs.
•\tServe as the primary point of contact for serious breach investigations.
•\tPrepare and submit serious breach notifications to applicable regulatory authorities within required timelines.
•\tDevelop and maintain standard operating procedures (SOPs) related to breach management.
•\tEnsure timely and thorough root cause analysis and CAPA development, working closely with functional area leads.
•\tMaintain breach documentation and logs in compliance with GCP and inspection expectations.
•\tSupport audits and regulatory inspections as a subject matter expert (SME) for serious breach.
•\tDeliver training and guidance to study teams and sites on breach awareness and reporting procedures.
•\tTrend and report breach data to identify process improvements or systemic quality issues.


Education & Experience Requirements:
•\tBachelor’s degree in life sciences, nursing, pharmacy, or related field.
•\t5+ years of clinical research experience, with at least 2 years in Clinical Quality, GCP Compliance, or related role.
•\tStrong working knowledge of ICH E6(R2/R3), EMA/MHRA/FDA serious breach expectations.
•\tProven experience in CAPA, root cause analysis, and deviation management.
•\tDemonstrated ability to communicate complex compliance issues clearly and effectively.
•\tComfortable working in a matrix organization and managing cross-functional customers.
•\tPrior experience with clinical quality systems (e.g., Veeva Vault, TrackWise, etc.) is a plus.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities:
•\tThorough knowledge of applicable GxP and appropriate regional regulations
•\tExtensive knowledge of the clinical trial process and serious breach reporting
•\tExcellent oral and written communication skills (including appropriate use of medical and scientific terminology)
•\tTraining/mentoring experience
•\tStrong attention to detail
•\tEffectively works independently or in a team environment
•\tHighly developed problem solving skills, risk assessment and impact analysis abilities
•\tStrong leadership skills
•\tStrong organizational and time management skills including ability to multitask and prioritize competing demands/work load
•\tStrong digital literacy; ability to learn and become proficient with appropriate software
•\tProven flexibility and adaptability
•\tAbility to qualify for and maintain a corporate credit card with sufficient credit line for business travel
•\tVeeva QMS experience a plus

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.