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Clinical trials pharmacy operational manager

Preston (Lancashire)
Lancashire Teaching Hospitals
Manager
Posted: 22h ago
Offer description

Job overview

If you’re energised by the idea of shaping a high‑performing clinical trials pharmacy service, this role gives you the platform to lead, innovate, and make a measurable impact on patient care and research delivery.

The Clinical Trials Pharmacy Operations Manager will take operational leadership of our expanding clinical trials pharmacy service, ensuring safe, efficient, and compliant delivery of investigational medicinal products (IMPs) across all research areas. You’ll work closely with multidisciplinary teams, sponsors, CROs, and internal stakeholders to streamline processes, support study setup, and maintain the highest standards of governance.

This is a pivotal role for someone who thrives in a dynamic environment, enjoys problem‑solving, and wants to influence how research is delivered within a forward‑thinking pharmacy department across our two hospitals sites.

You will join a high profile dedicated pharmacy clinical trials team working with our Centre for UK Clinical Research Facility hosted at Royal Preston Hospital. The Lancashire Clinical Research Facility, part of the NIHR UKCRF Network, is a dedicated to supporting early phase 1 and 2 studies. The facility works in partnership with community mental health trust, Lancashire and South Cumbria, the University of Lancaster and the University of Lancashire.

You’ll bring a blend of operational leadership, clinical trials knowledge, and a passion for improving systems and processes.

Main duties of the job

1. Oversee day‑to‑day operational management of the clinical trials pharmacy service.
2. Lead and support the clinical trials pharmacy team, ensuring high-quality, timely service delivery.
3. Manage workflow, capacity planning, and resource allocation across active and upcoming studies.
4. Ensure full compliance with GCP, MHRA requirements, Trust policies, and all regulatory frameworks.
5. Coordinate IMP receipt, storage, dispensing, accountability, and returns/destruction processes.
6. Support feasibility assessments, study setup, and pharmacy costing for new trials.
7. Develop and maintain SOPs, training materials, and operational documentation.
8. Work collaboratively with R&D, investigators, study teams, and external partners.
9. Acts as the main pharmacy contact for the BioNTech industry partnership agreement (a first NHS & industry partnership in England, 2025)
10. Contribute to service development, digital optimisation, and quality improvement initiatives.
11. Provide operational insight for audits, inspections, and risk assessments.

Working for our organisation

We have 10,000 fantastic people working hard to deliver quality services to our patients. Whatever your role, you help look after 370,000 people in our local area & give specialist care to 1.5 million people across Lancashire & Cumbria.

Working with us gives you the knowledge and sense of pride that every activity you do genuinely does make a difference to support our patients & staff, ensuring we keep thriving & delivering outstanding healthcare right across our local towns.

You’ll have access to varied development opportunities, learn new skills, meet fab people & do things you’d never have done. You’ll learn about working in a hospital, interacting with people from all different roles to build skills & enhance your career path.

You’ll make an impact, be challenged to think differently, be bold & help innovate to keep improving things. Everything we do centres around patient care which means your role is pivotal and something really to be proud of.

Detailed job description and main responsibilities

Duties include (not be limited to):

12. The role oversees the full lifecycle of clinical trials across the trust, ensuring efficient setup, conduct and close‑out in line with UK research governance, ICH‑GCP and regulatory requirements. It involves coordinating resources, managing approvals, maintaining high‑quality administrative and financial processes, and acting as a key liaison between investigators, research teams, sponsors, industry partners and regulatory bodies.
13. The post holder leads day‑to‑day operations of the pharmacy clinical trials service, including IMP management, environmental monitoring, dispensing, documentation, SOP development, and supporting monitoring visits. They will help shape strategic planning for the active trial portfolio, streamline commercial and early‑phase trial delivery, and work closely with internal pharmacy teams such as oncology, QA and technical services.
14. The role includes tracking KPIs, driving service improvement and cost efficiencies, managing and training junior staff, conducting risk assessments, troubleshooting operational issues, and ensuring compliance with medicines legislation. Strong organisational, analytical and digital skills are essential.
15. The post holder also communicates service information to stakeholders and deputises for the clinical trials service manager, providing leadership and performance management for the clinical trials pharmacy team.

For more information please see the job description or get in touch (see additional contact information section).

Person specification

Knowledge & Expeirence

Essential criteria

16. Highly developed Professional knowledge, underpinned by theory and experience.
17. Up to date knowledge and understanding GCP, GMP and its application and the regulations surrounding Clinical Trials and Pharmaceutical Manufacture
18. Knowledge and understanding of the Law and Ethics relating to dispensing medicines and clinical trials.
19. Previous experience of project work, audit and change management
20. Knowledge of clinical trial management, aseptic services clean room design and functioning
21. Experience of product development
22. Evidence of working within GCP/GMP/GDP guidelines
23. Extensive post qualifying, with some experience working in a hospital.

Desirable criteria

24. Management skills
25. Experience of clinical research
26. Phase 1 / 2 Clinical Trials experience
27. Experience of Pharmaceutical Manufacture in either a hospital or industrial environment or previous experience of managing clinical trials and aseptic dispensing services.
28. Specialist knowledge of Pharmaceutical Manufacturing Processes including equipment and facility design, construction, validation and testing.
29. Knowledge of product licensing and medical devices registration.

Qualifications & Education

Essential criteria

30. Masters degree in Pharmacy or, Honours degree in pharmaceutical sciences, chemistry or similar scientific subject if combined with further education and training such as the Scientist Training Programme (STP), S/NVQ Level 3 in Pharmacy Services and approved knowledge e.g. BTEC in pharmaceutical science or equivalent recognised pharmacy technician qualification.

Desirable criteria

31. Technical qualification such as Pharmacy, Pharmaceutical Technology, Quality Control, Engineering, Manufacturing.
32. Post graduate certificate in clinical research or similar post-qualified qualification or diploma in a relevant pharmaceutical field.
33. GPhC registration
34. Good Clinical Practice (GCP) Training
35. Project management qualification

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