Job summary
We are pleased to offer the opportunity for an enthusiastic, motivated and dynamic person to join the friendly specialist clinical trials pharmacy team, as the Clinical Trials Operational Manager. This post is suitable for a pharmacist or a technician.
There is already a clinical trials team in place, consisting of core staff and also staff who work jointly with other departments within pharmacy. The pharmacy clinical trials team are currently working on over 60 trials involving investigational medicinal products.
We are looking for a pharmacist or technician with experience in clinical trials, with knowledge of GCP and good organisational, decision making and time management skills. As operational manager you will co-ordinate the work of the pharmacy clinical trials team and be able to work flexibly and accurately under pressure. The job will require you to communicate and interact with a wide range of staff within the Trust and representatives of external trial organisations.
Part time applications could be considered.
Main duties of the job
The successful applicant would join an experienced team of specialist clinical trial pharmacy staff who provide a comprehensive service to oncology/ haemato-oncology and other specialities including ophthalmology, hepatology, ENT, cardiology and intensive care. The pharmacy clinical trial service is provided from both the main dispensary and the dedicated trial dispensary in the St Lukes Cancer centre, along with significant input from the pharmacy aseptic services department. The base for much of the work will be the clinical trial office in the main hospital.
About us
Royal Surrey is a compassionate and collaborative acute and community Trust. Recognising that our 5000 colleagues are our greatest strength, we offer a comprehensive health and wellbeing program along with a commitment to developing and advancing your career. Our diverse and welcoming Royal Surrey family will ensure you that you feel valued from your initial interview through your entire tenure.
We are clinically led and provide joined up care by bridging the gap between hospital and community services alongside regional specialist cancer care. Our main acute hospital site is in Guildford with community hospital sites at Milford, Haslemere and Cranleigh. We provide adult community health services in homes across Guildford and Waverley.
The Care Quality Commission (CQC) have given us an overall rating of Outstanding.
Royal Surrey has a strong reputation and history to build on. We are proud of our achievements and we are investing in our colleagues through our commitment to supporting professional development as well as investing more than £45 million in our physical environment and new equipment in the next few years. There has never been a better time to join us.
Although it isn't the Trusts normal practice, adverts may close early, so you are encouraged to submit an application as soon as possible.
A video about the Royal Surrey - https://www.youtube.com/watch?v=R96pMboIYdo
Job description
Job responsibilities
Responsible for operational management of the pharmacy clinical trials service in line with the pharmacy Clinical Trials Policy, the international ethical and scientific quality standard laid down in The International Conference on Harmonisation guidelines for Good Clinical Practice relating to trials (ICH GCP) and The EU Clinical trials directive (2001/20/EC) as transposed into UK law by the Medicines for Human Use (Clinical Trials ) Regulations 2004 (the legislation), and any other legislation or standards for the conduct of clinical trials Responsible for writing and implementing Standard Operating Procedures for clinical trials in accordance with the Pharmacy Clinical Trials Policy Responsible for organising and delivering induction training and competency validation programmes for clinical trials and GCP for all levels of staff within the pharmacy Responsible for instigating internal audit programmes to ensure compliance with GCP and current clinical trials legislative requirements Responsible for recruitment and line management of pharmacy clinical trial technicians and assistants
The Pharmacy Department at the Royal Surrey County Hospital and St Lukes Cancer Centre, in collaboration with the Post Graduate Medical Centre at the University of Surrey, supports trials being hosted by the Trust both within the aseptic services department and the main and satellite dispensaries. There are currently 119 trials on our books. This figure includes trials in feasibility, set-up, maintenance and waiting close down. This figure is set to rise in the future.
The post holder will manage the clinical trial team and co-ordinate the management of the Investigational Medicinal Products in all pharmacy trials.
Job description
Job responsibilities
Responsible for operational management of the pharmacy clinical trials service in line with the pharmacy Clinical Trials Policy, the international ethical and scientific quality standard laid down in The International Conference on Harmonisation guidelines for Good Clinical Practice relating to trials (ICH GCP) and The EU Clinical trials directive (2001/20/EC) as transposed into UK law by the Medicines for Human Use (Clinical Trials ) Regulations 2004 (the legislation), and any other legislation or standards for the conduct of clinical trials Responsible for writing and implementing Standard Operating Procedures for clinical trials in accordance with the Pharmacy Clinical Trials Policy Responsible for organising and delivering induction training and competency validation programmes for clinical trials and GCP for all levels of staff within the pharmacy Responsible for instigating internal audit programmes to ensure compliance with GCP and current clinical trials legislative requirements Responsible for recruitment and line management of pharmacy clinical trial technicians and assistants
The Pharmacy Department at the Royal Surrey County Hospital and St Lukes Cancer Centre, in collaboration with the Post Graduate Medical Centre at the University of Surrey, supports trials being hosted by the Trust both within the aseptic services department and the main and satellite dispensaries. There are currently 119 trials on our books. This figure includes trials in feasibility, set-up, maintenance and waiting close down. This figure is set to rise in the future.
The post holder will manage the clinical trial team and co-ordinate the management of the Investigational Medicinal Products in all pharmacy trials.
Person Specification
Qualifications
Essential
- NVQ Level 3 in Pharmacy Services plus underpinning knowledge from BTEC in Pharmaceutical Science or an equivalent accredited qualification OR Master's degree in Pharmacy and registration with GPhC
Desirable
- Successful completion of South East Regional Accredited Checking Technician Scheme (ACT) or an equivalent accredited qualification OR Certificate in clinical pharmacy or equivalent experience
- Completion of NVQ assessor qualification
Knowledge
Essential
- 5 Years Post Qualification as a Pharmacy Technician in a hospital or CT environment. OR 2 years as a pharmacist in a hospital or CT environment
- Previous experience of clinical trials (at least 2 years involvement at Band 6)
- Proven knowledge of clinical trials regulations including ICH-GCP Guidelines and the EU Directive (documented GCP training).
- Previous training experience
- Evidence of ongoing training and CPD
- Experience dealing with the multidisciplinary team
- Evidence of staff management and supervision including delegation
- Evidence of implementing changes
Desirable
Person Specification
Qualifications
Essential
- NVQ Level 3 in Pharmacy Services plus underpinning knowledge from BTEC in Pharmaceutical Science or an equivalent accredited qualification OR Master's degree in Pharmacy and registration with GPhC
Desirable
- Successful completion of South East Regional Accredited Checking Technician Scheme (ACT) or an equivalent accredited qualification OR Certificate in clinical pharmacy or equivalent experience
- Completion of NVQ assessor qualification
Knowledge
Essential
- 5 Years Post Qualification as a Pharmacy Technician in a hospital or CT environment. OR 2 years as a pharmacist in a hospital or CT environment
- Previous experience of clinical trials (at least 2 years involvement at Band 6)
- Proven knowledge of clinical trials regulations including ICH-GCP Guidelines and the EU Directive (documented GCP training).
- Previous training experience
- Evidence of ongoing training and CPD
- Experience dealing with the multidisciplinary team
- Evidence of staff management and supervision including delegation
- Evidence of implementing changes
Desirable
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.
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
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.
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
