Lead Clinical Trials Pharmacist

Clerkenwell Health; City of Westminster; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading Research Organisation in the UK is seeking a Lead Clinical Trial Pharmacist to oversee pharmacy-related aspects of clinical trial delivery. In this senior role, you'll ensure compliance with regulatory standards, manage pharmacy services, and provide crucial pharmaceutical guidance. Ideal candidates will have proven leadership in a clinical trials environment and strong knowledge of ICH-GCP and GMP standards. This role emphasizes high-quality participant care and offers an opportunity to contribute to advancing mental health research.

Qualifications

• Proven pharmacy leadership experience, ideally within clinical trials or a research environment.
• Strong understanding of ICH-GCP, GMP, MHRA standards and medicines legislation.
• Previous line management experience is essential.

Responsibilities

• Leading the pharmacy clinical trial service, ensuring compliance with legislation and internal SOPs.
• Acting as the key point of contact for pharmaceutical and clinical queries.
• Managing pharmacy set-up, prescription preparation and drug accountability.

Skills

Pharmacy leadership experience

Understanding of ICH-GCP

IMP management experience

Stakeholder management

Job description

We're looking for a Lead Clinical Trial Pharmacist to join our dynamic clinical site team. This is a senior role responsible for overseeing all pharmacy-related aspects of clinical trial delivery across Clerkenwell Health sites. As Lead Pharmacist, you'll ensure the safe, compliant and efficient management of medicines across all studies, provide expert pharmaceutical guidance to the wider team, and maintain high regulatory standards in line with ICH‑GCP, GMP, MHRA requirements and internal SOPs. What will the role entail?

Responsibilities

• Leading the pharmacy clinical trial service, ensuring compliance with UK/EU legislation, ICH‑GCP, GMP and internal SOPs
• Acting as the key point of contact for pharmaceutical and clinical queries on trial and non‑trial medicines
• Working closely with the multidisciplinary team to support safe delivery of Phase 1-3 clinical trials
• Reviewing protocols, pharmacy manuals and study documents, and providing feasibility and regulatory input
• Preparing pharmacy risk assessments and developing study‑specific pharmacy documents
• Managing pharmacy set‑up, prescription preparation and maintaining accurate drug accountability
• Leading all aspects of IMP management, including procurement, receipt, storage, dispensing, checking, returns and destruction
• Maintaining pharmacy site files and supporting monitoring visits
• Managing close‑out activities and ensuring appropriate archiving
• Overseeing non‑trial medication processes, including procurement, stock control and vendor assessments
• Ensuring pharmacy equipment is safe, calibrated and fit for purpose
• Writing, reviewing and updating pharmacy SOPs and quality documentation
• Contributing to the development of Clerkenwell Health's commercial pharmacy services
• Leading MHRA and Home Office compliance activities, including audits, inspections and controlled drug governance
• Conducting internal audits and ensuring adherence to medicines legislation and Home Office requirements
• Managing pharmacists in London & other Clerkenwell sites, supporting recruitment and onboarding, and supervising day‑to‑day performance
• Leading training for pharmacy and non‑pharmacy staff on clinical trial pharmacy processes
• Providing pharmaceutical care to participants, including counselling and medication oversight
• Collaborating with internal teams and external vendors to ensure high‑quality pharmacy operations

Qualifications

• Proven pharmacy leadership experience, ideally within clinical trials or a research environment
• Strong understanding of ICH‑GCP, GMP, MHRA standards and medicines legislation
• Experience with IMP management and clinical pharmacy processes
• Previous line management experience is essential
• Experience with stakeholder management would be advantageous
• Previous experience with the Home‑Office is essential
• Commitment to high‑quality participant care and continuous improvement

Clerkenwell Health is an innovative and leading Research Organisation specialising in the delivery of scientifically grounded clinical trials through its collaborative Contract Research Organisation, extensive Site Network and pioneering Therapy Development Programme. We focus on advancing Mental Health and CNS research, with particular expertise in supporting psychedelic drug development. At Clerkenwell Health, our core values are Compassion, Collaboration, Innovation and Integrity. If you're passionate about advancing mental health research and leading excellence in clinical trial pharmacy, we'd love to hear from you.