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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 different kinds of audits. The idóneo candidate will serve as a subject matter authority on audits handling and support other activities related to QA across the clinical development portfolio.
What You'll Do:
- Conduct complex internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines, and/or client contractual obligations.
- Identification of issues impacting the quality and/or integrity of clinical research programs, determination of root cause of non- conformance and development of strategies to address issues.




- Upon request performance of technical document review and other GxP practice activities in support of clinical development programs.
- Provision of audit reports to management.
- Planning and delivery of quality services for contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects. Leads process/quality improvement initiatives.
- Develops tools and other materials for tracking compliance management activities and analyzes trends.
- Mentors less experienced staff and serves as project lead for group projects. Creates formal networks with key contacts across the department

Education & Experience Requirements:
- Bachelor's degree in life sciences, nursing, pharmacy, or related field.
- 5+ years of clinical research experience, with at least 2 years in Clinical Quality, GCP Compliance, or related role.
- Strong working knowledge of ICH E6(R2/R3), EMA/MHRA/FDA expectati

📌 Compliance Manager (España)
🏢 Thermo Fisher Scientific
📍 España