Clinical Compliance Specialist III

at  Thermo Fisher Scientific

JOB DESCRIPTION

Thermo Fisher Scientific Inc. is seeking a highly motivated and experienced Clinical Compliance Specialist III to join our team. As a global leader in the industry, Thermo Fisher Scientific is dedicated to enabling our customers to make the world healthier, cleaner, and safer. We are a company that values inclusion and collaboration, where diverse experiences, backgrounds, and perspectives are highly valued.
In this role, you will have the unique opportunity to drive quality and compliance strategies across our organization. You will lead initiatives aimed at optimizing processes, behaviors, and performance, ensuring audit readiness. As a Clinical Compliance Specialist III, you will have the chance to interpret and analyze data, make sound business decisions, and successfully implement strategies with the support of a dedicated team.

REQUIREMENTS:

• Bachelor’s degree or equivalent with a minimum of 5 years of relevant experience.
• Extensive knowledge of the clinical trial process and understanding of ICH GCP, as well as other relevant regulations and guidelines.
• Strong problem-solving skills, including root cause analysis and corrective/preventive actions.
• Excellent organizational and time-management skills.
• Attention to detail and strong digital literacy.
• Ability to prioritize competing demands and handle workload effectively.
• Flexibility, adaptability, and the ability to promote teamwork in a multi-disciplinary setting.
• Strong critical thinking skills and the ability to prioritize workload to deliver exceptional results.

• Use structured problem-solving methodology to address issues and document in accordance with ALCOA principles within specified timelines.
• Lead small to medium-scale process improvement initiatives.
• Connect with representatives from other departments regarding compliance activities such as client audits, CAPA, and procedural documents.
• Develop materials, presentations, and tools to support the department’s remit and strategies.
• Provide training and mentorship to junior team members.