Overview
In this role you ensure quality and compliance across clinical research activities, acting as a GCP subject matter expert and guiding regulatory alignment. You will partner with cross-functional teams to manage risks, coordinate CAPAs, and support audits and inspections. The position sits at the heart of a fast-paced, growth-driven environment focused on delivering patient-focused clinical development. You will help foster a culture of continuous improvement and readiness for regulatory review, contributing to the delivery of high-quality trials. This is a chance to impact how Parexel advances therapies to patients worldwide.
Responsibilities
- Provide quality leadership on GCP-related activities and serve as a subject matter expert on clinical compliance
- Act as Clinical Compliance representative on study teams across therapeutic areas
- Foster cross-functional partnerships and provide ongoing coaching on compliance
- Conduct risk assessments of clinical trial activities and identify priority studies, key compliance activities, metrics, and high-risk vendors
- Identify, assess, and escalate significant quality and compliance issues, including serious breach support
- Participate in CRO and vendor governance for assigned studies and therapeutic areas
- Maintain relationships with CRO quality teams to review and address quality and compliance matters
- Support vendor evaluations as needed
- Develop responses and CAPAs for internal and external audit findings
- Provide guidance on quality management system activities, including deviation reporting, root cause analysis, and CAPA development
- Identify trends in quality and compliance risks and implement risk-based solutions
- Support internal audits, regulatory inspections, inspection readiness, and project team training
Key requirements
- Strong expertise in GCP compliance, quality risk management, and stakeholder partnership
- Experience in pharmaceutical, biotechnology, academic, or other regulated clinical research environments
- Ability to influence, coach, and collaborate across cross-functional teams
- Quality-focused mindset with attention to regulatory compliance
- Experience supporting audits, inspections, CAPA processes, and clinical quality management activities
- Bachelor's degree; 5+ years in academic, pharmaceutical, or biotechnology industry; 3+ years in clinical compliance, QA, or regulatory compliance
- Thorough knowledge of drug development and the clinical trial process; knowledge of current regulatory requirements and ICH GCP guidelines
- Strong written and verbal communication, organizational, and problem-solving skills
- Ability to work independently, manage multiple priorities, and collaborate within a team
- influence and coaching capabilities
- cross-functional collaboration
- attention to detail
- GCP compliance
- quality risk management
- audits and inspections
Clinical Compliance Manager - UK (Home-based) - FSP in London employer: PAREXEL
At Parexel, we pride ourselves on being an exceptional employer, offering a collaborative work culture that fosters innovation and professional growth. Our team members enjoy competitive benefits, including flexible working arrangements and opportunities for career advancement, all while contributing to impactful global clinical trials in a supportive environment across the UK, Poland, Serbia, and Hungary.
