Clinical Compliance Manager - UK (Home-based) - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart®.

About the Role

We are seeking a Clinical Compliance Manager to join our team in the UK in a permanent capacity.

As a Clinical Compliance Manager, you will play a critical role in supporting the quality and compliance of clinical research activities across therapeutic areas and study teams. Acting as a trusted GCP subject matter expert, you will provide guidance on regulatory requirements, ICH GCP guidelines, and company procedures that support the successful conduct of clinical studies.

This position is central to fostering a culture of quality, compliance, and continuous improvement. Using a risk-based approach, you will help identify and assess compliance risks, support informed decision-making, and partner with stakeholders to develop effective corrective and preventive actions. You will collaborate with cross-functional teams, contribute to inspection readiness activities, support audit and inspection responses, and help ensure clinical research activities are conducted to the highest quality standards.

You will join a fast-paced, growth-oriented environment where your expertise will directly support the advancement of clinical development programs and contribute to bringing new therapies to patients. This role offers the opportunity to build broad organizational partnerships, strengthen leadership capabilities, and expand expertise across quality, compliance, and clinical development.

Key Responsibilities

• Provide quality leadership and guidance to R&D stakeholders on GCP-related activities and serve as a subject matter expert for clinical compliance matters.
• Act as a Clinical Compliance representative on clinical study teams across assigned therapeutic areas.
• Build collaborative partnerships with cross-functional stakeholders and provide ongoing coaching and compliance guidance.
• Partner with stakeholders to conduct risk assessments of clinical trial activities and identify priority studies, key compliance activities, compliance metrics, and high-risk vendors.
• Identify, assess, and escalate significant quality and compliance issues, including support for serious breach evaluations.
• Participate in CRO and vendor governance activities for assigned studies and therapeutic areas.
• Establish and maintain strong working relationships with CRO quality teams to review and address quality and compliance matters.
• Support vendor evaluations as a subject matter expert when required.
• Partner with clinical teams and functional groups to develop responses and CAPAs associated with internal and external audit findings.
• Provide guidance on quality management system activities, including deviation reporting, root cause analysis, and CAPA development and evaluation.
• Identify trends in quality and compliance risks and collaborate with stakeholders to implement effective, risk-based solutions.
• Support internal audits, regulatory inspections, inspection readiness activities, and project team training to ensure ongoing regulatory preparedness.

Candidate Profile

You will thrive in this role if you bring:

• Strong expertise in GCP compliance, quality risk management, and stakeholder partnership
• Experience working within pharmaceutical, biotechnology, academic, or other regulated clinical research environments
• The ability to influence, coach, and collaborate effectively across cross-functional teams
• A quality-focused mindset with exceptional attention to detail and commitment to regulatory compliance
• Experience supporting audits, inspections, CAPA processes, and clinical quality management activities

Required Qualifications

• Bachelor's degree required (life science or a related discipline preferred)
• Minimum 5 years of experience within the academic, pharmaceutical, or biotechnology industry, including 3+ years in a clinical compliance, quality assurance, or regulatory compliance role
• Thorough knowledge of drug development and the clinical trial process
• In-depth knowledge of current regulatory requirements and ICH GCP guidelines, including experience with international regulations, guidelines, and standards
• Strong written and verbal communication, organizational, and problem-solving skills
• Demonstrated ability to work independently, manage multiple priorities, and collaborate effectively within a team environment

Preferred Qualifications

• Degree in life science or a related scientific discipline
• Working knowledge of CAPA management, risk management, regulatory inspections, and GLP requirements
• Experience supporting vendor oversight and governance activities
• Experience leading or supporting inspection readiness initiatives and regulatory inspection preparation

If this job does not sound like the next step in your career, but perhaps you know of someone who would be a perfect fit, send them the link to apply!

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.