Clinical Pharmacy Team Leader Clinical Trials

Clinical Pharmacy Team Leader Clinical Trials

Anexciting opportunity for an enthusiastic, experienced, self-motivatedpharmacist to join the pharmacy Clinical Trials Management Team at LeedsTeaching Hospitals NHS Trust has arisen. Applicants should have experience ofworking with clinical trials and a good understanding of trial regulationsand Good Clinical Practice.

Thispost will provide leadership for clinical trials across 3 sites. It is an exciting time to work in researchdue to recent expansion of the Clinical Research Facilities (CRF), vaccineinnovation pathway workstreams and ongoing development of a world class hubfor innovation. You will support and expand services for the growing numberof early phase, ATIMP and complex studies including development of strategiesfor clinical trial delivery across cross sector boundaries.

Akey component of the role will be to oversee and develop current systems andprocesses to facilitate a more streamline approach to the pharmacy managementof clinical trials. This will include strategic service planning and capacitymanagement in the short and longer term.

Youwill work closely with several internal and external teams including clinicalpharmacists, aseptic services, CRF team, investigators and research nurses,Trust R&I team, University of Leeds Sponsor QA team and pharmaceuticalcompanies.

Main duties of the job

Themain duties for staff working in this role are:

Operational delivery and governanceoversight of the clinical trials service and management of the seniorpharmacists.

To identify and lead improvementwork on MMPS clinical trial set-up processes to provide a service that meetsand responds to the Trusts performance targets for initiation and deliveryof NIHR portfolio clinical trials.

To support the Lead Pharmacist forClinical Trials in strategic service review, quality improvement and planningto meet innovative service opportunities.

Provide advice and information inrelation to all medicines related aspects of R&I activities within theTrust to ensure compliance with national legislation and guidelines.

Liaise with all key stakeholdersincluding pharmacy aseptics, research teams, trial sponsors and Trust R&Iregarding IMP handling issues.

To provide highly specialisedadvice and lead on the MMPS Clinical Trial governance oversight forUniversity of Leeds and LTHT joint sponsored studies.

To work with other MMPS CPTLs andOperational Leads to support development of services in line with Trust andMMPS strategies.

About us

LeedsTeaching Hospitals NHS Trust is one of the largest teaching hospitals in theUK with a large number of specialised and highly specialised services. It has an established reputation as aCentre of Excellence for delivering high quality research and innovation on alarge scale with pharmacy currently supporting over 350 clinical trialsacross all hospital sites.

Leedsis a wonderful city to work in and LTHT is an organisation that puts itspatients first and highly values and supports its staff. Pharmacy is aforward-thinking department that values the contribution of all our staff andis recognised in the organisation for our collaborative working as wecontinuously support our workforce to develop to their potential indelivering the best patient care.

LeedsTeaching Hospitals is committed to our process of redeploying 'at risk'members of our existing workforce to new roles. As such, all our job advertsare subject to this policy and we reserve the right to close, delay or removeadverts while this process is completed. If you do experience a delay in theshortlisting stage of the recruitment cycle, please bear with us while thisprocess is completed, and contact the named contact if you have anyquestions.

Job responsibilities

Tomanage a team of pharmacists delivering specialist clinical pharmacy servicesto Clinical Trials and R&I clinical support Units (CSUs) within theTrust. To be the first point of contact, and support for the CSUs, on allmatters relating to pharmacy.

Provide expert opinion, both withinand outside pharmacy, to ensure the safe and effective delivery of drugtherapy to defined clinical areas.

Provide pharmaceutical professionalleadership for defined clinical areas by liaison with pharmacy operationalservices and key members of the CSU. Be responsible for professionalleadership for specified area of Trust e.g. locality hospital.

The post holder will also performthe role of an advanced clinical pharmacist to a Research and Innovation(R&I) trial portfolio. In this role, the post holder will ensuremedicines are used appropriately, safely, and cost-effectively in accordancewith Trust policy, standard operating procedures and medicine legislation.The post holder is expected to determine how the outcomes are best achievedin specific circumstances.

Manage a team of specialistpharmacists providing clinical trial pharmacy services to the definedclinical areas and CSUs

Responsible for the provision ofinformation to the CSUs regarding clinical and financial governance, andissues around service delivery and future developments

Responsible for the co-ordinationof training for pharmacists and other healthcare professionals on aspects ofdrug use within defined clinical specialities.

Provide a minimum of at least onesession of professional supervisory cover in the clinical trialdispensaries other related activity.The post holder will be required to work evenings, weekends and Bank Holidayson a rotational basis.

To act as the responsiblepharmacist in line with local procedures.

To oversee the governance anddelivery of the Medicines Management and Pharmacy Services CSU (MMPS)clinical trial portfolio. To workalongside the Operational Deputy - Clinical Trials Service Manager to ensurestudies are set up and delivered in line with regulatory and sponsorrequirements.

Provide expert advice andinformation in relation to all medicines related aspects of R&Iactivities within the Trust and Regionally to ensure compliance with localand national legislation and guidelines.

To provide highly specialisedadvice and lead on the MMPS Clinical Trial governance oversight forUniversity of Leeds and LTHT joint sponsored studies.

Person Specification Experience

• Clinical Trials
• Understanding of application of GCP
• Leadership
• Advanced clinical pharmacy
• Line management
• Knowledge of clinical trials regulations

Qualifications

• UK Registered Pharmacist with the General Pharmaceutical Council
• Full GCP certification
• Line management or leadership qualification

Skills & behaviours

• Influencing and negotiating
• Team player
• Lateral thinking and problem solving

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.