Clinical Compliance Manager Home-based; FSP

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®.

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.

• 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 elevate 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.

You…