Clinical Compliance Manager – FSP

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Offer effective leadership and direction to R&D stakeholders regarding GCP-related initiatives.

• Act as a subject matter expert on clinical compliance issues.

• Serve as a Clinical Compliance representative on clinical study teams within designated therapeutic areas.

• Forge collaborative relationships with cross-functional stakeholders while providing continuous coaching and compliance advice.

• Execute risk assessments of clinical trial operations, pinpointing priority studies, essential compliance activities, compliance metrics, and high-risk vendors.

• Recognize, evaluate, and escalate significant quality and compliance concerns, including support for serious breach evaluations.

• Engage in CRO and vendor governance activities for assigned studies and therapeutic areas.

• Sustain working relationships with CRO quality teams to review and resolve quality and compliance issues.

• Assist in vendor evaluations as a subject matter expert.

• Formulate responses and CAPAs related to internal and external audit findings.

• Provide insights on deviation reporting, root cause analysis, and the development and evaluation of CAPAs.

• Detect trends in quality and compliance risks and apply effective, risk-based solutions.

• Assist with internal audits, regulatory inspections, inspection readiness efforts, and project team training.

⛳️ Requirements

• A bachelor's degree is required, preferably in life sciences or a related field.

• At least 5 years of experience in the academic, pharmaceutical, or biotechnology sectors.

• Over 3 years of experience in a clinical compliance, quality assurance, or regulatory compliance capacity.

• Comprehensive understanding of drug development and the clinical trial process.

• Extensive knowledge of current regulatory requirements and ICH GCP guidelines.

• Familiarity with international regulations, guidelines, and standards.

• Excellent written and verbal communication, organizational, and problem-solving capabilities.

• Capability to work autonomously, manage multiple tasks, and effectively collaborate within a team setting.

• Strong proficiency in GCP compliance, quality risk management, and stakeholder collaboration.

• Experience in pharmaceutical, biotechnology, academic, or other regulated clinical research environments.

• Ability to influence, mentor, and work collaboratively across cross-functional teams.

• Exceptional attention to detail and a strong commitment to regulatory compliance.

• Experience in supporting audits, inspections, CAPA processes, and clinical quality management activities.

• Proficient knowledge of CAPA management, risk management, regulatory inspections, and GLP requirements.

• Experience in vendor oversight and governance activities.

• Background in leading or assisting inspection readiness initiatives and preparing for regulatory inspections.

🏝️ Benefits

• Permanent employment opportunity.

• Flexible working arrangements.

• Opportunities for professional growth.

• Chance to develop extensive organizational partnerships.

• Opportunity to enhance leadership skills.

• Possibility to broaden expertise in quality, compliance, and clinical development.