Job summary
Expected Shortlisting Date
05/12/2024
Planned Interview Date
19/12/2024
An exciting opportunity for an enthusiastic, experienced, self-motivated pharmacy technician to join the pharmacy Clinical Trials Management Team at Leeds Teaching Hospitals NHS Trust has arisen. Applicants should have experience of working with clinical trials and a good understanding of trial regulations and Good Clinical Practice.
This post will provide operational leadership for clinical trials across 3 sites. It is an exciting time to work in research due to recent expansion of the Clinical Research Facilities (CRF) and planned development of 2 new state of the art hospitals including a world class hub for innovation. You will support and expand services for the growing number of early phase, ATIMP and complex studies including development of strategies for clinical trial delivery across cross sector boundaries.
A key component of the role will be to develop current systems and processes to facilitate a more streamline approach to the pharmacy management of clinical trials. This will include strategic service planning and capacity management in the short and longer term.
You will work closely with several internal and external teams including clinical pharmacists, aseptic services, CRF team, investigators and research nurses, Trust R&I team, University of Leeds Sponsor QA team and pharmaceutical companies.
Main duties of the job
Operational delivery oversight of the clinical trials service and management of the lead technicians.
Review and improve current MMPS clinical trial set-up and delivery processes to provide a service that meets the Trusts performance in initiation and delivery targets for NIHR portfolio clinical trials.
To support the Lead Pharmacist for Clinical Trials in strategic service review, quality improvement and planning to meet innovative service opportunities.
Provide advice and information in relation to all medicines related aspects of R&I activities within the Trust to ensure compliance with national legislation and guidelines.
Liaise with all key stakeholders including pharmacy aseptics, research teams, trial sponsors and Trust R&I regarding IMP handling issues.
To support sponsor related functions with LTHT and University of Leeds joint sponsor QA team, providing expert advice on IMP sourcing and management.
To work with other MMPS Operational Leads to support development of services in line with Trust and MMPS strategies.
Oversee the Clinical Trials team in preparing for clinical trial audits and inspections by trial sponsors, pharmaceutical companies and regulatory agencies.
Assist in the provision of training to pharmacy staff on GCP and regulatory frameworks, guidelines, policies and procedures relating to clinica
About us
Leeds Teaching Hospitals NHS Trust is one of the largest teaching hospitals in the UK with a large number of specialised and highly specialised services. It has an established reputation as a Centre of Excellence for delivering high quality research and innovation on a large scale with pharmacy currently supporting over 350 clinical trials across all hospital sites.
Leeds is a wonderful city to work in and LTHT is an organisation that puts its patients first and highly values and supports its staff. Pharmacy is a forward-thinking department that values the contribution of all our staff and is recognised in the organisation for our collaborative working as we continuously support our workforce to develop to their potential in delivering the best patient care.
Leeds Teaching Hospitals is committed to our process of redeploying 'at risk' members of our existing workforce to new roles. As such, all our job adverts are subject to this policy and we reserve the right to close, delay or remove adverts while this process is completed. If you do experience a delay in the shortlisting stage of the recruitment cycle, please bear with us while this process is completed, and contact the named contact if you have any questions.
Job description
Job responsibilities
Responsible for the provision and leadership of Pharmacy Clinical Trial Services across the trust, to ensure the supply of clinical trial medicines to patients at LTH follows all legal and statutory controls in a safe and effective manner ensuring best quality patient care.
Responsible for the development and coordination of a governance and legal framework for the pharmacy clinical trial supply services.
Responsible for the clinical trial medicines supply service to the Trust.
Responsible for making decisions where practice or service delivery issues are concerned.
Responsible for ensuring all Trust dispensaries comply with legal and professional requirements in line with the General Pharmaceutical Council and Good Clinical Practice.
Responsible for service development and short/long term strategic planning.
Responsible for ensuring premises are secure and maintained and that all H&S policies are adhered to.
To manage teams of Pharmacists and Specialist Pharmacy Technicians (Dispensary managers) Trust wide.
To deputise for the Lead Pharmacist Clinical Trials and R&I as required.
Responsible for budgetary controls and resources, including pay and non-pay budget.
Accountable to the Lead Pharmacist Clinical Trials and R&I, the post holder will ensure that all quality targets and other relevant local performance standards are delivered, and the highest standards of patient care and service delivery are maintained, reviewed and audited.
Works alongside clinical colleagues to ensure that the service capacity is utilised in the most optimal way, balancing demand with safe delivery and capacity management.
Manage career development, recruitment strategies and workforce planning.
To ensure the patient centred approach of all staff working within dispensary areas.
Responsible for the service provision delivered from three dispensaries across three sites
Responsible for the cost-effective management of drug stock within clinical trial dispensaries, ensuring stock holding is maintained at adequate levels and is monitored regularly.
Responsible for all clinical trial medicines in clinical areas to ensure the safe and secure storage of medicines and the compliance with all legal frameworks relating to medicines storage and supply from these areas.
Provide expert opinion, both within and outside pharmacy, to ensure the safe and effective provision of medicines.
To liaise and engage with stakeholders in other healthcare organisations, notably those within the RRDN to ensure appropriate service needs are met.
Provide professional leadership for the pharmacy clinical trial services by liaison with pharmacy clinical colleagues, LTHT R&I and key members of the CSUs Trust wide.
To provide professional support cover in absence of managerial colleagues.
To provide cover during dispensary and ward sessions to ensure service is not compromised
Participate in weekend and Bank Holiday and late night working on a rotational basis.
Person Specification
Qualifications
Essential
1. Registrant of General Pharmaceutical Council
2. BTEC in Pharmaceutical Sciences or equivalent
3. Full Good Clinical Practice Certification
Desirable
4. Service Improvement Certification or equivalent experience
5. Professional Management or leadership qualification
Experience
Essential
6. In depth knowledge of hospital pharmacy working practices
7. Proven ability to lead, motivate and develop staff
8. Proven ability to deal with highly complex managerial issues
9. Experience of managing a multidisciplinary team
10. Experience of writing and implementing procedures
11. Thorough knowledge and application of Good Clinical Practice
12. Thorough knowledge of legislative aspects of medicines use
Desirable
13. Experience of managing significant change within a team
14. Experience of conflict resolution
15. Financial management skills
Additional Requirements
Essential
16. Excellent time management
Skills & behaviours
Essential
17. Excellent attention to detail
18. Excellent negotiation and persuasion slkills
19. Ability to meet objectives and work independantly
20. Ability to work effectively with and influence very senior peers across the organisation
21. Ability to work using own initiative