Principal Pharmacist Clinical Trials Operations

NHS
Manchester
3 months ago
Applications closed

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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. Your responsibilities will include oversight of day‑to‑day service delivery, staff management, capacity planning and performance against national and Trust‑defined metrics. You will work closely with the wider research and pharmacy leadership team, ensuring seamless delivery of investigational products and continuous service improvement, supporting the Trust's ambition to expand its research portfolio.


Job Summary

The Christie is one of Europe's leading cancer centres, treating over 60,000 patients a year. The Clinical Trials Pharmacy Department supports more than 600 experimental medicine studies and works closely with university partners and multinational sponsors. As principal pharmacist – clinical trials operations you will ensure patients have access to the latest developments in oncology and haematology investigational medicines while maintaining the highest standards of safety, quality and regulatory compliance.


Responsibilities

  • Lead the operational delivery of the Clinical Trials Pharmacy service, ensuring timely, efficient and compliant implementation of trials across The Christie and partner sites.
  • Provide senior operational leadership to the clinical trials pharmacy team, line‑managing senior staff and supporting workforce planning, recruitment and the development of sustainable staffing models.
  • Oversee pharmacy input into trial feasibility assessments, coordinating with aseptic services, ward teams, the CRF and external stakeholders.
  • Monitor, analyse and report on operational performance data, using outcomes to drive quality improvement and highlight service impact across the research portfolio.
  • Identify service delivery risks and lead on operational problem‑solving to ensure safe, efficient and regulatory‑compliant delivery of investigational products.
  • Develop and embed local processes, SOPs and workflows that support operational efficiency and promote best practice.
  • Collaborate with the Principal Pharmacist Clinical trials strategy to align operational priorities with strategic aims.
  • Engage with Trust‑wide and external research delivery partners to contribute to wider operational planning and strategic development.
  • Represent the clinical trials pharmacy team at operational meetings, escalating service pressures and proposing solutions.
  • Champion continuous service improvement, identifying innovations, improving delivery models and enhancing patient and stakeholder experience.
  • Support financial sustainability by aligning operational planning with income generation and efficient use of resources.
  • Work with Aseptic Services and Contract Manufacturing Organisations to ensure appropriate record keeping for clinical trial activity.
  • Maintain your own portfolio of hosted clinical trials as nominated pharmacy lead to designated disease groups, providing pharmaceutical advice and resolving issues with research teams.
  • Line‑manage designated pharmacy staff, supporting professional development, appraisals and objective setting.
  • Ensure staff are trained and competent to undertake clinical trial duties in accordance with SOPs, GCP and regulatory requirements.
  • Foster a supportive, inclusive and high‑performing culture across the clinical trials pharmacy team.
  • Support workforce planning and recruitment in collaboration with pharmacy leadership.
  • Promote a safe working environment and maintain completion of delegation and reading logs for pharmacy staff.
  • Ensure delivery of pharmacy trial services in compliance with local, national and international governance frameworks, including MHRA expectations, GCP and requirements.
  • Support preparation, coordination and delivery of responses to regulatory inspections and sponsor‑initiated audits.
  • Monitor and manage operational risks, identifying potential non‑compliance and escalating appropriately.
  • Implement and maintain SOPs, policies and work instructions, escalating quality or safety concerns as needed.
  • Investigate incidents, near misses and quality concerns promptly and thoroughly, contributing to root‑cause analyses.
  • Work with the accountable pharmacist for Aseptic Services to ensure audit action plans are implemented effectively.
  • Act as the principal point of contact for operational matters related to pharmacy delivery of clinical trials, maintaining effective relationships with stakeholders.
  • Communicate complex and sensitive information clearly to a range of audiences.
  • Liaise with the Trust's Research & Innovation Division, Clinical Trials Unit and other corporate teams.
  • Collaborate closely with other senior members of the Clinical Trials Pharmacy Service to ensure alignment between strategic planning and operational delivery.
  • Participate in internal and external meetings, forums and working groups related to clinical trials and service performance.
  • Build and maintain professional relationships with clinical trials pharmacists across NHS and research institutions.
  • Provide clear, supportive communication to direct reports and foster a positive, inclusive team culture.
  • Escalate risks, performance issues or resource pressures to senior pharmacy leadership in a timely and solution‑focused manner.
  • Communicate complex and highly technical information to staff and multidisciplinary members, demonstrating expert knowledge of clinical trial law.
  • Interpret and analyse a wide range of operational data, guiding service improvement and resource planning.
  • Exercise sound professional judgement when managing competing priorities, resolving delivery challenges and addressing safety concerns.
  • Use professional knowledge to assess feasibility of pharmacy trial delivery, highlighting risks and constraints.
  • Contribute to business cases and service proposals by analysing workload trends, workforce needs and financial implications.
  • Investigate operational incidents and service issues, undertaking root‑cause analysis and contributing to quality improvement initiatives.
  • Apply up‑to‑date knowledge of clinical trial regulations and pharmacy processes to remain legally and professionally sound.
  • Identify opportunities for service efficiency, innovation and digital transformation, working collaboratively with colleagues to assess risks and benefits.
  • Support senior pharmacy leadership in monitoring financial performance, including income generation, workload reimbursement and resource utilisation.
  • Ensure all pharmacy activity relating to clinical trials is accurately recorded and submitted for cost recovery and service sustainability.
  • Contribute to income forecasting and service costing exercises, aligning with actual trial activity, staffing models and resource needs.
  • Work collaboratively with the R&I finance team, service managers and sponsor organisations to provide input into trial funding models.
  • Oversee the day‑to‑day use and maintenance of physical assets and environments, ensuring suitability, security and compliance.
  • Promote good stewardship of resources within the team, supporting value‑for‑money decision‑making, waste reduction and efficient workflow design.

Qualifications

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

Desirable Qualifications

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

Experience

  • Significant post‑registration experience in hospital pharmacy
  • Significant, demonstrable 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 Experience

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

Skills

  • 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
  • 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 Skills

  • 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

  • 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 Knowledge

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

Values

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

Desirable Values

  • Champion of innovation and service development in research pharmacy

Other

  • 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 Other

  • 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 will require a Disclosure and Barring Service check.


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.


UK Registration

Applicants must have current UK professional registration.


Employer details

The Christie NHS FT
Pharmacy Trials – E00922
Manchester, M20 BX


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