Principal Pharmacist – Clinical Trials Operations

We have an exciting opportunity for a motivated pharmacist to join our Clinical Trials Pharmacy team as the principal pharmacist – clinical trials operations. This role is essential as you will be responsible for the safe, efficient and compliant delivery of pharmacy services supporting clinician trials across The Christie. This includes oversight of day-to-day service delivery, staff management, capacity planning, and performance against national and Trust-defined metrics. The post-holder will work collaboratively with the wider research and pharmacy leadership team including aseptic services, ward areas, and the Clinical Research Facility to ensure seamless delivery of investigational products and continuous service improvement, supporting the Trust's ambition to expand its research portfolio.

The Christie has a dedicated Clinical Trials Pharmacy Department supporting more than 600 experimental medicine studies. As part of this team, you will help ensure patients have access to the latest developments in oncology and haematology investigational medicines. You will work in a multidisciplinary environment with pharmacy, clinical, and research colleagues to deliver safe and innovative treatments.

The department is involved in large-scale collaborative projects and has strong academic links with the University of Manchester. Many team members have undertaken postgraduate training or secondments, and we are committed to supporting your development.

Principal Pharmacist – Clinical Trials Operations - Please see Detailed job description and main responsibilities

The Christie is one of Europe's leading cancer centres, treating over 60,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 15% patients are referred to us from other parts of the country.

We provide radiotherapy through one of the largest radiotherapy departments in the world; chemotherapy on site and through 14 other hospitals; highly specialist surgery for complex and rare cancer; and a wide range of support and diagnostic services. We are also an international leader in research, with world first breakthroughs for over 100 years.

We run one of the largest early clinical trial units in Europe with over 300 trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.

DUTIES AND RESPONSIBILITIES

Service Delivery and Development

1. Lead the operational delivery of the Clinical Trials Pharmacy service, ensuring timely, efficient, and compliant implementation of trials across The Christie and its partner sites, in alignment with national set-up timelines, Trust-defined metrics, and departmental objectives.

2. Provide senior operational leadership to the clinical trials pharmacy team, including line management of senior staff, supporting workforce planning, recruitment, and the development of sustainable staffing models to meet increasing service demand.

3. Oversee pharmacy input into trial feasibility assessments, contributing to the development of robust capacity plans and coordinating with aseptic services, ward teams, the CRF, and external stakeholders to ensure end-to-end delivery of investigational products.

4. Monitor, analyse and report on operational performance data (e.g. set-up timelines, workload volume, dispensing activity), using outcomes to drive quality improvement and highlight service impact across the research portfolio.

5. Identify service delivery risks and lead on operational problem-solving to ensure the safe, efficient and regulatory-compliant delivery of investigational products.

6. Develop and embed local processes, SOPs, and workflows that support operational efficiency and promote best practice in the set-up and delivery of clinical trials pharmacy services.

7. Collaborate with the Principal Pharmacist – Clinical trials strategy to align operational priorities with strategic aims, supporting the development of business cases for service expansion, digital innovation, and enhanced trial delivery capacity.

8. Engage with Trust-wide and external research delivery partners (e.g. CRF, R&I, regional pharmacy networks) to contribute to wider operational planning and strategic development.

9. Represent the clinical trials pharmacy team at operational meetings within the pharmacy department and across the Trust, escalating service pressures, proposing solutions, and contributing to cross-functional improvement workstreams.

10. Champion a culture of continuous service improvement, working collaboratively with staff to identify innovations, improve delivery models, and enhance the experience of patients and stakeholders engaged in clinical research.

11. Support financial sustainability of the service by aligning operational planning with income generation, recovery mechanisms, and efficient use of resources.

12. Work with Aseptic Services and Contract Manufacturing Organisations to ensure appropriate record keeping and maintenance for clinical trial activity involving their services

13. To maintain their own portfolio of hosted clinical trials, acting as nominated pharmacy lead to designated disease group(s). Provide pharmaceutical advice on the conduct of CTIMP trials and assess study requirements and resolve pharmaceutical issues with the research teams.

Staff Management and Leadership

1. Line manage designated pharmacy staff involved in the delivery of clinical trials, including pharmacists and technical staff, supporting their professional development, appraisals, and objective setting.

2. Ensure staff are trained and competent to undertake clinical trial duties, in accordance with relevant SOPs, GCP, and regulatory requirements.

3. Foster a supportive, inclusive, and high-performing culture across the clinical trials pharmacy team, promoting continuous improvement and staff engagement.

4. Support workforce planning and recruitment in collaboration with pharmacy leadership to ensure sufficient staff capacity and capability for trial delivery.

5. To ensure completion of delegation and reading logs in relation to pharmacy staff

6. To take responsibility for promoting a safe working environment.

Governance and Compliance

1. Ensure pharmacy trial services are delivered in compliance with local, national, and international research governance frameworks, including MHRA expectations, GCP, and sponsor requirements.

2. Support the preparation, coordination and delivery of responses to regulatory inspections and sponsor-initiated audits, ensuring issues are addressed in a timely and professional manner.2

3. Monitor and manage operational risks within the clinical trials pharmacy service, identifying potential areas of non-compliance and escalating appropriately to senior leadership.

4. Implement and maintain SOPs, policies, and work instructions to support safe, consistent practice across the clinical trials pharmacy team, escalating quality or safety concerns as needed.

5. Ensure incidents, near misses, and quality concerns are investigated promptly and thoroughly, contributing to root cause analyses and promoting a culture of learning and accountability.

6. Work with the accountable pharmacist for Aseptic Services to ensure resultant action plans from regional audits are implemented in a timely and effective manner.

Communications and Working Relationships

1. Act as the principal point of contact for all operational matters relating to pharmacy delivery of clinical trials, maintaining effective working relationships with internal and external stakeholders.

2. Communicate complex and sensitive information clearly and effectively to a range of audiences, including clinical trial sponsors, investigators, CRF staff, aseptic services, and multidisciplinary teams.

3. Liaise with the Trust's Research & Innovation Division, Clinical Trials Unit (if applicable), and other corporate teams to ensure pharmacy input is effectively integrated into trial set-up and delivery processes.

4. Collaborate closely with other senior members of the Clinical Trials Pharmacy Service to ensure alignment between strategic planning and operational delivery.

5. Participate in and contribute to internal and external meetings, forums, and working groups related to clinical trials, research delivery, and service performance.

6. Build and maintain professional relationships with clinical trials pharmacists across other NHS and research institutions to share best practice and contribute to national dialogue on operational delivery.

7. Provide clear, supportive communication to direct reports, ensuring alignment with service priorities and fostering a positive, inclusive team culture.

8. Escalate risks, performance issues, or resource pressures to senior pharmacy leadership in a timely and solution-focused manner.

Analytical and Judgement Skills

1. Communicating complex and highly technical information to staff and multidisciplinary members both internal and external to the Trust. The post-holder will have expert knowledge of the law pertaining to the conduct of clinical trials, and will need to convey this information and their interpretation of it to colleagues and stakeholders.

2. Interpret and analyse a wide range of operational data (e.g. trial activity, capacity reports, set-up timelines, turnaround times), using this to guide service improvement, resource planning, and escalation of risks where required.

3. Exercise sound professional judgement when managing competing priorities, resolving service delivery challenges, or addressing safety concerns—balancing regulatory, clinical, and operational considerations.

4. Use professional knowledge to assess the feasibility of pharmacy trial delivery, highlighting risks and constraints related to capacity, infrastructure, and staffing.

5. Contribute to business cases and service proposals by analysing workload trends, workforce needs, and financial implications, supporting evidence-based decision-making.

6. Investigate operational incidents and service issues, undertaking root cause analysis and contributing to quality improvement initiatives and the development of preventative actions.

7. Apply up-to-date knowledge of clinical trial regulations and pharmacy processes to ensure operational decisions remain legally and professionally sound.

8. Identify opportunities for service efficiency, innovation, or digital transformation, working collaboratively with colleagues to assess risks and benefits.

Responsibility for Financial and Physical Resources

1. Support the senior pharmacy leadership in monitoring the financial performance of the clinical trials pharmacy service, including income generation, workload reimbursement, and resource utilisation.

2. Ensure that all pharmacy activity relating to clinical trials is accurately recorded and submitted to support appropriate cost recovery and service sustainability.

3. Contribute to income forecasting and service costing exercises, providing operational input to ensure alignment with actual trial activity, staffing models, and resource needs.

4. Work collaboratively with the R&I finance team, service managers, and sponsor organisations to ensure pharmacy input into trial funding models, including site-specific costings and local costing templates.

5. Oversee the day-to-day use and maintenance of physical assets and environments (e.g. dispensing areas, trial storage facilities), ensuring they are suitable, secure, and compliant with pharmacy and research regulations.

6. Promote good stewardship of resources within the team, supporting value-for-money decision making, waste reduction, and efficient workflow design.