Advanced Clinical
Clinical Compliance Manager
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Clinical Compliance Manager (GCP) | Permanent | UK | FSP
Advanced Clinical is looking for a Clinical Compliance Manager to join our FSP team, embedded with a leading biopharmaceutical sponsor. This is a permanent role based in the UK.
About the role
You'll provide GCP compliance support to therapeutic area and clinical study teams, acting as the go-to expert on regulatory requirements, ICH GCP and SOPs. You'll take a risk-based approach to prioritising compliance activity, spotting issues early, escalating where needed, and helping teams build practical action plans to address quality risks. You'll also be an important link to the wider organisation, helping to build a culture of quality and compliance.
What you'll do
- Act as GCP expert and consultant to R&D colleagues, providing quality leadership and guidance
- Join clinical study teams as the Clinical Compliance representative for your therapeutic areas
- Build strong relationships across R&D, offering coaching and compliance advice
- Run ongoing risk assessments of clinical trial activity to identify priority studies, compliance metrics, high-risk vendors and key activities such as protocol review, vendor evaluations and inspection readiness
- Identify and escalate significant quality and compliance issues, including assessing serious breaches
- Take part in CRO and vendor governance, build relationships with CRO quality teams and support vendor evaluations as an SME
- Support teams with responses and CAPAs for internal and external audit findings
- Guide teams on quality management activities, including deviations, root cause analysis and CAPA development
- Spot trends in quality issues and work with functional managers on timely, risk-managed solutions
- Lead and support inspection readiness, preparing teams for regulatory inspections and supporting them during and after audits
- Advise on business initiatives involving systems, processes and tools used in clinical trial conduct
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What we're looking for
- At least 5 years in academia, pharma or biotech, including 3+ years in clinical compliance, quality assurance or regulatory compliance
- Hands-on clinical operations experience, for example as a Clinical Trial Manager or in a similar study delivery role. You'll know what can go wrong, what's feasible and how to work through CAPAs. This matters more than audit experience alone
- Oncology or neuroscience experience in clinical operations is a real advantage
- In-depth knowledge of ICH GCP and international regulations and guidelines
- Strong understanding of drug development and the clinical trial process
- Working knowledge of CAPA and risk management and regulatory inspections is a plus, and GLP is also helpful
- A bachelor's degree, ideally in a life science or related subject
- Excellent written and verbal communication, with the ability to influence and gain buy-in
- Disciplined, detail-oriented and able to work independently and juggle priorities in a fast-paced environment
- Strong problem-solving skills and the ability to resolve difficult conflicts
- A collaborative approach to working with internal partners and in teams
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Advanced Clinical is committed to diversity and inclusion and welcomes applications from everyone, regardless of background or personal characteristics.
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