Principal Pharmacist – Clinical Trials Operations

Job responsibilities

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 Trusts 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 concernsbalancing 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.

Qualifications

Essential

• Current GPhC registration
• Masters degree in Pharmacy
• Postgraduate diploma in clinical pharmacy or equivalent experience

Desirable

• Postgraduate qualification in clinical research, experimental medicine, or a closely related field

Experience

Essential

• Significant post-registration experience in hospital pharmacy
• Significant, demonstratable experience working in clinical trials pharmacy
• Experience in developing and delivering training and education to multidisciplinary teams
• Demonstrates ability to effectively mentor others within the team and/or service

Desirable

• Recognised management qualification
• Report and business case writing
• Oncology experience

Skills

Essential

• Excellent written and verbal communication skills
• Strong critical appraisal, problem-solving, and analytical skills
• Ability to analyse, interpret, apply and communicate complex regulatory and technical information to a wide range of individuals which may be in challenging circumstances
• Proven ability to work autonomously and collaboratively across disciplines
• Demonstratable project and change management skills at a senior pharmacy level
• Effective team building and delegation skills
• Excellent interpersonal, negotiating and influencing skills
• Proven ability to respond and shape resources (financial, people) to deliver strategic priorities
• Demonstrates ability to successfully manage a project at team, and/or service level, prioritise and meet deadlines
• Use skills to manage difficult and dynamic situations

Desirable

• Experience influencing external stakeholders or policy development
• Demonstrable high-level understanding of current issues on cancer services and clinical trials
• Advanced data analysis or audit/evaluation skills
• Demonstrates application of critical evaluation skills in the context of working practice

Knowledge

Essential

• In-depth knowledge of procedures within an aseptic unit/GMP
• Strong understanding of the clinical trial lifecycle, including trial set-up, feasibility, and sponsor oversight
• Knowledge of NHS cancer strategies
• Expert in providing high quality clinical pharmacy service

Desirable

• In-depth knowledge of GCP, GDP, and UK Clinical Trials Regulations

Values

Essential

• Demonstrates the NHS values and The Christie Trust values in practice
• Committed to patient-centred care and continuous improvement

Desirable

• Champion of innovation and service development in research pharmacy

Other

Essential

• Required to work unsocial hours (on a rota basis with other team members), including evenings, weekends, Bank Holidays and on-call
• Ability to travel to other sites as required
• Willingness to participate in regional or national working groups
• Commitment to ongoing professional development

Desirable

• Member of relevant national clinical trials or oncology pharmacy network (e.g. BOPA, NPCTAG)
• Driving license and access to a car

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).