Job summary
An exciting opportunity has arisen for an experienced, enthusiastic, and self-motivated pharmacy technician to join the pharmacy Clinical Trials Management Team at Leeds Teaching Hospitals NHS Trust.
In this capacity, you will assume responsibility for leading, developing, and supporting the technical systems and processes that underpin the assessment, pharmacy setup, and ongoing management of all clinical trials conducted within LTHT.
You will act as a key point of contact with a number of internal and external teams including clinical pharmacists, aseptic pharmacy services, the Clinical Research Facility teams, investigators and research nurses, the Trust Research & Innovation team, and pharmaceutical companies.
Candidates must possess demonstrable experience in clinical trials, alongside a comprehensive understanding of Clinical Trial Regulations and Good Clinical Practice to ensure compliance and excellence in trial management.
Main duties of the job
You will collaborate closely with the Clinical Trials Lead Technician based at St Jamess Hospital to drive service improvements to meet the needs of service users and share best practice across clinical trials pharmacy.
You will hold key responsibility for the costing of complex studies, ensuring accurate reimbursement for clinical trial activities, and providing essential pharmacy input for lead site study costings via the NCVR process.
Furthermore, you will play a pivotal role in the pharmacy approval process for new studies, with a focus on specialties across Leeds General Infirmary and Chapel Allerton Hospital. Your efforts will be crucial in ensuring timely approvals that align with DHSC set-up timelines, thereby facilitating the smooth and efficient initiation of research.
To excel in this role, you must demonstrate exceptional communication skills, flexibility, reliability, and the ability to work proactively and independently. Experience in accuracy checking is also essential to maintain the highest standards of quality and safety.
This position is primarily based at Leeds General Infirmary, with occasional duties at other sites to provide comprehensive support to the service.
About us
Leeds Teaching Hospitals is one of the largest and busiest acute trusts in England. We are involved in research at all levels, developing and trialling new treatments for patients. We believe that being involved in cutting-edge research helps us to provide better care.
The Pharmacy Clinical Trials Team at LTHT provides support to nearly 400 trials with an expanding portfolio in all areas, including specialist early phase trials and those investigating advanced therapeutic medicinal products (ATIMPs).
We are a friendly, supportive and forward-thinking department, committed to delivering a high-quality service and providing the very best standard of care for patients.
As a large teaching hospital, we operate a weekend, evening and Bank Holiday service in our inpatient dispensaries. You will be required to work these on a rotational basis.
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
Reporting to the Clinical Trial Services Manager the post holder will:
Develop specialist technical services for the conduct of clinical trials in line with national and regulatory requirements.
Help to set the strategic direction for the technical element of the Pharmacy Clinical Trial service
Develop and review pharmacy practices and standard operating procedures for the clinical trials service, ensuring compliance with UK regulations and Good Clinical Practice (GCP) guidelines.
Lead, manage and develop technical staff within the clinical trials team, providing leadership, motivation, direction, advice and support.
Be responsible on a day-to-day basis for efficient and effective management of the technical elements of the pharmacy clinical trial service.
Ensure all technical and support staff are appropriately trained to perform the range of duties required for service delivery.
Drive, plan and implement developments in the clinical trials service in order to meet the needs of service users
Line manage and mentor the Specialist Technician for clinical trials
Report departmental statistics, including dispensing errors and incidents, to the Clinical Trial Management Team on a monthly basis.
Lead on costing and income recovery to ensure appropriate remuneration and to maintain service financial sustainability.
Job description
Job responsibilities
Reporting to the Clinical Trial Services Manager the post holder will:
Develop specialist technical services for the conduct of clinical trials in line with national and regulatory requirements.
Help to set the strategic direction for the technical element of the Pharmacy Clinical Trial service
Develop and review pharmacy practices and standard operating procedures for the clinical trials service, ensuring compliance with UK regulations and Good Clinical Practice (GCP) guidelines.
Lead, manage and develop technical staff within the clinical trials team, providing leadership, motivation, direction, advice and support.
Be responsible on a day-to-day basis for efficient and effective management of the technical elements of the pharmacy clinical trial service.
Ensure all technical and support staff are appropriately trained to perform the range of duties required for service delivery.
Drive, plan and implement developments in the clinical trials service in order to meet the needs of service users
Line manage and mentor the Specialist Technician for clinical trials
Report departmental statistics, including dispensing errors and incidents, to the Clinical Trial Management Team on a monthly basis.
Lead on costing and income recovery to ensure appropriate remuneration and to maintain service financial sustainability.
Person Specification
Experience
Essential
- Substantial management or supervisory experience of technical and support staff
- Experience of developing and implementing Standard Operating Procedures (SOPs) within ICH/GCP and Clinical Trial regulations.
- Managing change
- Team working and leadership can build effective working relationships with team/customers and colleagues.
Desirable
- Risk assessments and risk management
- Managing budgets
Other
Essential
- Understanding of local and national developments and guidelines relating to clinical trials
Skills & behaviours
Essential
- Able to plan effectively both own work and that of the specialist team
- Able to identify opportunities for improvement and development of the service
- Problem solving ability
- Able to influence and persuade others and remain calm in difficult situations.
Qualifications
Essential
- NVQ level 3 in Pharmacy Services or equivalent
Desirable
- GCP certification
- Supervisory or Management qualification
Person Specification
Experience
Essential
- Substantial management or supervisory experience of technical and support staff
- Experience of developing and implementing Standard Operating Procedures (SOPs) within ICH/GCP and Clinical Trial regulations.
- Managing change
- Team working and leadership can build effective working relationships with team/customers and colleagues.
Desirable
- Risk assessments and risk management
- Managing budgets
Other
Essential
- Understanding of local and national developments and guidelines relating to clinical trials
Skills & behaviours
Essential
- Able to plan effectively both own work and that of the specialist team
- Able to identify opportunities for improvement and development of the service
- Problem solving ability
- Able to influence and persuade others and remain calm in difficult situations.
Qualifications
Essential
- NVQ level 3 in Pharmacy Services or equivalent
Desirable
- GCP certification
- Supervisory or Management qualification
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.
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).
Additional information
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.
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).
