Job summary
The Cambridge Clinical Trials Unit (CCTU) is part of the NIHR UKCRC Registered CTU Network with the remit to provide support for all aspects of clinical trials from set-up to close down within the Cambridge Biomedical Research Centre.
Applications are invited for the post of Quality Assurance Manager in the CCTU. The QA Manager will develop, implement and maintain systems to assure the quality of Cambridge sponsored clinical trials undertaken within Cambridge University Hospitals NHS Foundation Trust (CUHNHSFT), and its partners in Cambridge University Health Partners (CUHP).
The post holder will be the accountable lead for quality management across the CCTU and ensure accordance with the Good Clinical Practice Guidelines (GCP), Good Clinical Laboratory Practice (GCLP) principles, Good Manufacturing Practice (GMP), the Research Governance Framework for Health & Social Care (2005) and the Medicines for Human Use (Clinical Trials) Regulations 2004.
Previous experience of working in a quality/clinical research environment within the NHS, University or pharmaceutical industry is essential for this post, together with knowledge and experience of UK regulations, guidelines and requirements for clinical research.
Main duties of the job
The post holder main duties:
- Coordinate the activities required to maintain and develop systems for assuring the quality of facilities, procedures, processes and data to the highest standards and maintain legal and regulatory compliance of Cambridge sponsored Clinical Trials of Investigational Medicinal Products (CTIMPS).
- Oversee the validation of procedures and under the direction of the Operations Director, ensure that all the necessary preparation has been undertaken for internal and external audit and/or regulatory inspection by the Medicines and Healthcare Products Regulatory Agency (MHRA) and other external bodies.
- Provide management direction, guidance and advice on all aspects of compliance.
- Develop the CCTU internal Audit plan, working with the Operations Director, and undertake these audits for ensuring ongoing compliance
- Act as CCTU Archivist with responsibility for oversight of archiving within CCTU
- Maintain and oversee the selection of vendors/laboratories
About us
Our Trust
Cambridge University Hospitals (CUH) NHS Foundation Trust comprises Addenbrooke's Hospital and the Rosie Hospital in Cambridge. With over 13,000 staff and over 1100 beds the priorities of the Trust focus on a quality service which is all about people - patients, staff and partners. Recognised as providing 'outstanding' care to our patients and rated 'Good' overall by the Care Quality Commissioner, is testament to the skill and dedication of the people who work here. CUH's values - Together - Safe, Kind, Excellent - are at the heart of patient care, defining the way all staff work and behave. The Trust provides accessible high-quality healthcare for the local people of Cambridge, together with specialist services, dealing with rare or complex conditions for a regional, national and international population.
CUH is committed to promoting a diverse and inclusive community - a place where we can all be ourselves. We value our differences and fully advocate and support an inclusive working environment where every individual can fulfil their potential. We want to ensure our people are truly representative of all the communities that we serve. We welcome applications for all positions in the organisation irrespective of people's age, disability, ethnicity, race, nationality, gender identity, sex, sexual orientation, religion or belief, marriage and civil partnership status, or pregnancy and maternity status or social economic background.
Job description
Job responsibilities
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
Please note:- Internal applicants on permanent contracts can only apply for this post as a secondment and must have the approval of your current line manager before applying.
This vacancy will close at midnight on 18th August 2024
Interviews are due to be held on 6th September 2024
Benefits to you
We offer development opportunities and a wide range of benefits including on-site leisure facilities, shopping concourse, day nurseries and access to a great transport system with easy access to airports and rail travel.
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases, alternative working hours will be considered.
We welcome applications from the Armed Forces.
Job description
Job responsibilities
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
Please note:- Internal applicants on permanent contracts can only apply for this post as a secondment and must have the approval of your current line manager before applying.
This vacancy will close at midnight on 18th August 2024
Interviews are due to be held on 6th September 2024
Benefits to you
We offer development opportunities and a wide range of benefits including on-site leisure facilities, shopping concourse, day nurseries and access to a great transport system with easy access to airports and rail travel.
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases, alternative working hours will be considered.
We welcome applications from the Armed Forces.
Person Specification
Qualifications
Essential
- Science degree or equivalent professional qualification in a relevant discipline, or equivalent experience.
- Quality Assurance training qualification.
Desirable
- Post-graduate qualification.
- Professional membership e.g. BARQA
Experience
Essential
- Extensive experience working in a regulated QA environment leading continuous process improvement in the health/pharmaceuticals sector.
- Experience of inspection and audit in a GCP/GCLP and/or GMP environment.
- Management and control of documentation.
- Experience of developing and implementing new SOPs and processes.
Desirable
- Experience of GCP and GCLP/GMP.
- Risk and incident trend analysis.
- ISO 9001 accreditation system.
- Developing and/or delivering training.
- Experience of writing and delivering reports to influence strategic direction.
Knowledge
Essential
- Knowledge of ICH-GCP, GMPO and/or GCLP.
- Knowledge of EU Directives and UK statutory instrument.
- Knowledge of audits and associated processes.
- Knowledge of trial archiving requirements.
Desirable
Skills
Essential
- Experience of writing and working to Standing Operating Procedures.
- Excellent IT Skills, including databases and MS Office suite.
- Excellent communication skills with proven ability to work effectively as part of a team.
- Proven ability to resolve QA issues with colleagues, investigators and other collaborators.
- Excellent organizational skills.
- Ability to work to highest level of detail.
- Ability to deliver specialized training in quality management in clinical research.
Desirable
- Skilled user of database software, IDEAGEN Quality Management (Q-Pulse) or similar
Additional Requirements
Essential
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of safe, kind, excellent.
- Flexible approach to working and a desire to develop knowledge and career.
- Self-motivated and able to work independently showing initiative and good judgement.
Person Specification
Qualifications
Essential
- Science degree or equivalent professional qualification in a relevant discipline, or equivalent experience.
- Quality Assurance training qualification.
Desirable
- Post-graduate qualification.
- Professional membership e.g. BARQA
Experience
Essential
- Extensive experience working in a regulated QA environment leading continuous process improvement in the health/pharmaceuticals sector.
- Experience of inspection and audit in a GCP/GCLP and/or GMP environment.
- Management and control of documentation.
- Experience of developing and implementing new SOPs and processes.
Desirable
- Experience of GCP and GCLP/GMP.
- Risk and incident trend analysis.
- ISO 9001 accreditation system.
- Developing and/or delivering training.
- Experience of writing and delivering reports to influence strategic direction.
Knowledge
Essential
- Knowledge of ICH-GCP, GMPO and/or GCLP.
- Knowledge of EU Directives and UK statutory instrument.
- Knowledge of audits and associated processes.
- Knowledge of trial archiving requirements.
Desirable
Skills
Essential
- Experience of writing and working to Standing Operating Procedures.
- Excellent IT Skills, including databases and MS Office suite.
- Excellent communication skills with proven ability to work effectively as part of a team.
- Proven ability to resolve QA issues with colleagues, investigators and other collaborators.
- Excellent organizational skills.
- Ability to work to highest level of detail.
- Ability to deliver specialized training in quality management in clinical research.
Desirable
- Skilled user of database software, IDEAGEN Quality Management (Q-Pulse) or similar
Additional Requirements
Essential
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of safe, kind, excellent.
- Flexible approach to working and a desire to develop knowledge and career.
- Self-motivated and able to work independently showing initiative and good judgement.
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).
Employer details
Employer name
Cambridge University Hospital NHS Foundation Trust
Address
Addenbrookes Hospital-Division R&D
Addenbrookes' Hospital
Cambridge Biomedical Campus
CB2 0QQ
Employer's website
https://www.cuh.nhs.uk (Opens in a new tab)