Job summary
To provide comprehensive management and oversight of the laboratories within the CRF and CCTC across RHH, NGH and WPH. This will involve the development and streamlining of processes and procedures underpinning the activity within the laboratories and establishing collaborative and supportive working practices across the units.
Working within the requirements of Good Clinical Practice and Good Laboratory Practice at all times as well as ensuring that the departments are operating in line with STH policies and procedures. The Laboratory Manger will take responsibility for ensuring that all laboratory related Sponsor requirements are satisfied.
The laboratory manager will undertake service improvement initiatives and take responsibility for audit and quality assurance within the laboratory remit. This will include evaluation of new equipment, methodology and advice on best options to the CCTC/CRF management structures.
Main duties of the job
The post holder will ensure that they are working within the requirements of Good Clinical Practice and Good Laboratory Practice at all times as well as ensuring that the departments are operating in line with STH policies and procedures. All units must be MHRA inspection ready at all times and the Laboratory Manger will take responsibility for ensuring that all laboratory related Sponsor requirements are satisfied including oversight of equipment and temperature control, sampling and processing, storage, shipping and reporting.
The role will include taking responsibility for the laboratories and ensuring that all staff using the facilities are appropriately trained and supported to do so.
About us
You will be working for an organisation which values and respects all of its staff and the community it serves. The Trust is a leader in the NHS and research sectors and provides excellent benefits for its staff. This includes commitments to professional development but also many policies to support employees in balancing their personal and professional lives.
This vacancy is advertised on a fixed term contract basis for a period of 12 months due to the post being externally funded. The fixed term contract status of the post holder will be reviewed in accordance with the Trust's legal obligations regarding fixed term contracts taking into consideration the ongoing source of the external funding and the requirement for the post to be maintained.
Please also note any secondment must first be agreed with your current line manager.
Job description
Job responsibilities
Please view the attached Job Description and Person Specification documents for full details regarding this post.
MAIN DUTIES AND RESPONSIBILITIES
General Laboratory tasks
- Ensure that laboratory related trial procedures are conducted in accordance with approved protocols
- Update and develop laboratory manuals for each unit including ensuring there is a robust out of hours decant process
- Provide routine technical support in the correct handling, processing, storage and documentation of clinical samples in accordance with HTA and other legislative guidelines
Management
- Have day to day responsibility for the quality of the laboratories and actively contributes and drives processes to meet MHRA requirements.
- Review performance of staff using the facilities and make recommendations for development and further training
- Take a lead role in the monitoring of quality standards and performance
Quality Management
- Ensure that both units are inspection ready at all times
- Update and implement Standard Operating Procedures, policies and systems in accordance with GCP and GLP standards always acting in accordance with MHRA and Sponsor standards and requirements
- Lead on laboratory related quality audits including reporting findings and anomalies to senior management and developing corrective and preventative actions as appropriate
Personal Development
- Be accountable for own professional actions and work for long periods of time without direct supervision.
- Complete and maintain GCP training and regular updates as required
- Maintain and update IT Skills as necessary
Job description
Job responsibilities
Please view the attached Job Description and Person Specification documents for full details regarding this post.
MAIN DUTIES AND RESPONSIBILITIES
General Laboratory tasks
- Ensure that laboratory related trial procedures are conducted in accordance with approved protocols
- Update and develop laboratory manuals for each unit including ensuring there is a robust out of hours decant process
- Provide routine technical support in the correct handling, processing, storage and documentation of clinical samples in accordance with HTA and other legislative guidelines
Management
- Have day to day responsibility for the quality of the laboratories and actively contributes and drives processes to meet MHRA requirements.
- Review performance of staff using the facilities and make recommendations for development and further training
- Take a lead role in the monitoring of quality standards and performance
Quality Management
- Ensure that both units are inspection ready at all times
- Update and implement Standard Operating Procedures, policies and systems in accordance with GCP and GLP standards always acting in accordance with MHRA and Sponsor standards and requirements
- Lead on laboratory related quality audits including reporting findings and anomalies to senior management and developing corrective and preventative actions as appropriate
Personal Development
- Be accountable for own professional actions and work for long periods of time without direct supervision.
- Complete and maintain GCP training and regular updates as required
- Maintain and update IT Skills as necessary
Person Specification
Qualifications
Essential
- Educated to degree level in a biological science or equivalent experience
Desirable
- Quality Management qualification or equivalent experience
Qualifications
Essential
- Educated to Masters level or evidence of relevant leadership and management experience in a clinical research environment
- Knowledge of GCP/regulatory and governance requirements for clinical trials
- Knowledge of safety regulations such as HTA, HSE and COSHH
- Knowledge and understanding of the Laboratory QMS system
Desirable
- Risk Management qualification or equivalent experience
Experience
Essential
- Substantial experience in clinical chemistry/biomedical laboratory work for academic/commercial research studies
- Experience of GCP/GLP or other regulatory environments in the workplace
- Experience of line managing and training staff
- Experience of developing and implementing Quality Assurance Systems to meet legislative requirements
- Demonstrable experience of implementing new systems for improvement
- Experience of writing, maintaining and reviewing controlled documents and producing information for external reports (e.g for regulatory agencies)
- Evidence of excellent communication, negotiating and leadership skills
- Experience of liaising with a wide variety of stakeholders on all levels
- Experience of liaising with external regulatory agencies
- Knowledge and understanding of risk management process
- Experience of use and requirements of electronic errors and incidence records eg Datix
- Experience of process innovation and other service improvement initiatives
- Demonstrable self-awareness, an understanding of impact on others and an ability to manage self and maintain professional conduct in difficult and challenging situations
Desirable
- Experience of training and assessing staff competencies to audit
Special Skills/Aptitudes
Essential
- Excellent attention to detail
- Excellent verbal and written communication skills
- Excellent problem solving skills
- Management of complex tasks
- Ability to perform complex root cause analysis and investigation of complex errors and incidents
Experience
Essential
- Experience of conducting audits
- Able to evidence a flexible approach to work
Further Training
Essential
Special Skills/Aptitudes
Essential
- Ability to communicate with all grades of staff in a professional and concise manner time management
- Excellent organisational skills and an ability to prioritise an unpredictable workload with frequent disruption
- Show good time management skills
- Ability to prioritise work
- Ability to work independently to achieve targets
- Possess good IT skills (Outlook,Word,Excel,Qpulse)
- To maintain accurate records
- Ability to train and guide staff in QMS and risk matters
Other Factors
Essential
- Flexible approach to working
- Commitment to the role
Person Specification
Qualifications
Essential
- Educated to degree level in a biological science or equivalent experience
Desirable
- Quality Management qualification or equivalent experience
Qualifications
Essential
- Educated to Masters level or evidence of relevant leadership and management experience in a clinical research environment
- Knowledge of GCP/regulatory and governance requirements for clinical trials
- Knowledge of safety regulations such as HTA, HSE and COSHH
- Knowledge and understanding of the Laboratory QMS system
Desirable
- Risk Management qualification or equivalent experience
Experience
Essential
- Substantial experience in clinical chemistry/biomedical laboratory work for academic/commercial research studies
- Experience of GCP/GLP or other regulatory environments in the workplace
- Experience of line managing and training staff
- Experience of developing and implementing Quality Assurance Systems to meet legislative requirements
- Demonstrable experience of implementing new systems for improvement
- Experience of writing, maintaining and reviewing controlled documents and producing information for external reports (e.g for regulatory agencies)
- Evidence of excellent communication, negotiating and leadership skills
- Experience of liaising with a wide variety of stakeholders on all levels
- Experience of liaising with external regulatory agencies
- Knowledge and understanding of risk management process
- Experience of use and requirements of electronic errors and incidence records eg Datix
- Experience of process innovation and other service improvement initiatives
- Demonstrable self-awareness, an understanding of impact on others and an ability to manage self and maintain professional conduct in difficult and challenging situations
Desirable
- Experience of training and assessing staff competencies to audit
Special Skills/Aptitudes
Essential
- Excellent attention to detail
- Excellent verbal and written communication skills
- Excellent problem solving skills
- Management of complex tasks
- Ability to perform complex root cause analysis and investigation of complex errors and incidents
Experience
Essential
- Experience of conducting audits
- Able to evidence a flexible approach to work
Further Training
Essential
Special Skills/Aptitudes
Essential
- Ability to communicate with all grades of staff in a professional and concise manner time management
- Excellent organisational skills and an ability to prioritise an unpredictable workload with frequent disruption
- Show good time management skills
- Ability to prioritise work
- Ability to work independently to achieve targets
- Possess good IT skills (Outlook,Word,Excel,Qpulse)
- To maintain accurate records
- Ability to train and guide staff in QMS and risk matters
Other Factors
Essential
- Flexible approach to working
- Commitment to the role
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).
