Quality Assurance Manager - CCTU
UCL
9 hours ago
Posted date9 hours ago
N/A
Minimum levelN/A
EngineeringJob category
EngineeringAbout us
The UCL Institute of Clinical Trials and Methodology
The Institute was established on 1 August 2013 and is formally comprised of two Research Departments: The MRC Clinical Trials Unit at UCL (MRC CTU) and the Comprehensive Clinical Trials Unit at UCL (CCTU) within the Faculty of Population Health Science. The Institute also has two further units that are virtual members: The Cancer Research UK & UCL Cancer Trials Centre and the PRIMENT Clinical Trials Unit.
The Faculty brings together expertise in Child Health, Women's and Reproductive Health, Population Health, Global Health, Cardiovascular Science, Clinical Trials and Health Informatics, in a unique grouping that spans the life-course.
Comprehensive Clinical Trials Unit (CCTU)
The Comprehensive Clinical Trials Unit is a specialist unit set up within the Institute of Clinical Trials and Methodology with a specific remit to design, conduct, analyse and publish clinical trials and other well-designed studies.
The CCTU provides clinical, statistical and trial operations leadership and facilitates the delivery of high quality, regulatory compliant clinical trials of both investigational medicinal products (IMPs) (in compliance with the UK regulations governing the conduct of clinical trials of IMP) and other non-IMP trials and studies.
The CCTU is a registered CTU with the capability to centrally coordinate multi-centre clinical trials (i.e. having overall responsibility for the design, development, recruitment, data management and analysis of trials) with robust systems to ensure conduct and delivery of clinical trials to the highest quality standards.
About the role
An enthusiastic, committed and professional individual is sought for the role of Quality Assurance Manager, which is based in Holborn, London. The main purpose of this post is to ensure that staff at the CCTU conduct clinical trials in accordance with applicable guidelines and regulations. In particular the role holder is responsible for maintaining and overseeing Quality Management Systems at the CCTU, including the portfolio of central standard operating procedures (SOPs), providing/arranging staff training relating to the procedures and conducting a programme of internal audits. The position involves liaison with all staff at the CCTU and with a wide range of academic, managerial and administrative staff, including the Joint Research Office, the Institute of Clinical Trials and Methodology and other departments within UCL. Contact with regulatory bodies and research ethics committees regarding QA and auditing issues is also essential to the role.
Interviews will take place in person on 24th and 25th March.
If you have any queries regarding the vacancy or the application process, to arrange an informal discussion regarding the post please contact Felicia Ikeji at f.ikeji@ucl.ac.uk
This is a permanent role, which is available immediately.
About you
The successful applicant must possess a postgraduate degree and/or equivalent experience in Clinical Trials, as well as a comprehensive understanding of UK Clinical Trials Regulations, ICH Good Clinical Practice, the European Directives on Clinical Trials and Good Clinical Practice and the Department of Health's Research Governance Framework. Experience of working in a clinical trial regulatory environment is also required. Experience of staff supervision or line management would be required for this post as well as experience of establishing and maintaining quality management systems.
What we offer
As well as the exciting opportunities this role presents, we also offer some great benefits some of which are below:
• 41 Days holiday (27 days annual leave 8 bank holiday and 6 closure days)
• Additional 5 days' annual leave purchase scheme
• Defined benefit career average revalued earnings pension scheme (CARE)
• Cycle to work scheme and season ticket loan
• Immigration loan
• Relocation scheme for certain posts
• On-Site nursery
• On-site gym
• Enhanced maternity, paternity and adoption pay
• Employee assistance programme: Staff Support Service
• Discounted medical insurance
Visit https://www.ucl.ac.uk/work-at-ucl/rewards-and-benefits to find out more.
Our commitment to Equality, Diversity and Inclusion
We particularly welcome applications from black and minority ethnic candidates as they are underrepresented within UCL at this level". UCL Taking Action for Equality We will consider applications to work on a part-time, flexible and job share basis wherever possible. We offer the opportunity to work flexibly between our office and home, along with core hours and flexible start/finish times. Our department holds an Athena SWAN Bronze award, in recognition of our commitment to advancing gender equality.
The UCL Institute of Clinical Trials and Methodology
The Institute was established on 1 August 2013 and is formally comprised of two Research Departments: The MRC Clinical Trials Unit at UCL (MRC CTU) and the Comprehensive Clinical Trials Unit at UCL (CCTU) within the Faculty of Population Health Science. The Institute also has two further units that are virtual members: The Cancer Research UK & UCL Cancer Trials Centre and the PRIMENT Clinical Trials Unit.
The Faculty brings together expertise in Child Health, Women's and Reproductive Health, Population Health, Global Health, Cardiovascular Science, Clinical Trials and Health Informatics, in a unique grouping that spans the life-course.
Comprehensive Clinical Trials Unit (CCTU)
The Comprehensive Clinical Trials Unit is a specialist unit set up within the Institute of Clinical Trials and Methodology with a specific remit to design, conduct, analyse and publish clinical trials and other well-designed studies.
The CCTU provides clinical, statistical and trial operations leadership and facilitates the delivery of high quality, regulatory compliant clinical trials of both investigational medicinal products (IMPs) (in compliance with the UK regulations governing the conduct of clinical trials of IMP) and other non-IMP trials and studies.
The CCTU is a registered CTU with the capability to centrally coordinate multi-centre clinical trials (i.e. having overall responsibility for the design, development, recruitment, data management and analysis of trials) with robust systems to ensure conduct and delivery of clinical trials to the highest quality standards.
About the role
An enthusiastic, committed and professional individual is sought for the role of Quality Assurance Manager, which is based in Holborn, London. The main purpose of this post is to ensure that staff at the CCTU conduct clinical trials in accordance with applicable guidelines and regulations. In particular the role holder is responsible for maintaining and overseeing Quality Management Systems at the CCTU, including the portfolio of central standard operating procedures (SOPs), providing/arranging staff training relating to the procedures and conducting a programme of internal audits. The position involves liaison with all staff at the CCTU and with a wide range of academic, managerial and administrative staff, including the Joint Research Office, the Institute of Clinical Trials and Methodology and other departments within UCL. Contact with regulatory bodies and research ethics committees regarding QA and auditing issues is also essential to the role.
Interviews will take place in person on 24th and 25th March.
If you have any queries regarding the vacancy or the application process, to arrange an informal discussion regarding the post please contact Felicia Ikeji at f.ikeji@ucl.ac.uk
This is a permanent role, which is available immediately.
About you
The successful applicant must possess a postgraduate degree and/or equivalent experience in Clinical Trials, as well as a comprehensive understanding of UK Clinical Trials Regulations, ICH Good Clinical Practice, the European Directives on Clinical Trials and Good Clinical Practice and the Department of Health's Research Governance Framework. Experience of working in a clinical trial regulatory environment is also required. Experience of staff supervision or line management would be required for this post as well as experience of establishing and maintaining quality management systems.
What we offer
As well as the exciting opportunities this role presents, we also offer some great benefits some of which are below:
• 41 Days holiday (27 days annual leave 8 bank holiday and 6 closure days)
• Additional 5 days' annual leave purchase scheme
• Defined benefit career average revalued earnings pension scheme (CARE)
• Cycle to work scheme and season ticket loan
• Immigration loan
• Relocation scheme for certain posts
• On-Site nursery
• On-site gym
• Enhanced maternity, paternity and adoption pay
• Employee assistance programme: Staff Support Service
• Discounted medical insurance
Visit https://www.ucl.ac.uk/work-at-ucl/rewards-and-benefits to find out more.
Our commitment to Equality, Diversity and Inclusion
We particularly welcome applications from black and minority ethnic candidates as they are underrepresented within UCL at this level". UCL Taking Action for Equality We will consider applications to work on a part-time, flexible and job share basis wherever possible. We offer the opportunity to work flexibly between our office and home, along with core hours and flexible start/finish times. Our department holds an Athena SWAN Bronze award, in recognition of our commitment to advancing gender equality.
JOB SUMMARY
Quality Assurance Manager - CCTU
UCL
London
9 hours ago
N/A
Full-time
Quality Assurance Manager - CCTU