Job summary
Sonic Healthcareis an internationally renowned healthcare provider with a demonstrable track record of medical across the world. Headquartered in Sydney, Australia, Sonic is an ASX Top 50 company that has grown to become one of the worlds leading healthcare providers, specialising in pathology, radiology and primary care medical centres. We have operations in Australia, the USA, Germany, Belgium, Switzerland, the United Kingdom, Ireland and New Zealand.
TDL Trials offers highly specialised and regulatory compliant pathology services for single and multicentre Phase I, II and III clinical trials, safety and pharmacodynamic testing, and patient-monitoring services to Pharmaceutical, Biotechnology and Research organisations. We pride ourselves on our ability to offer a bespoke service, and we are committed to service excellence.
From our London ISO 15189-accredited laboratories, TDL supports a wide range of therapeutic areas for organisations undertaking clinical studies throughout the UK, Europe, Australasia and the USA. And as we are part of Sonic Healthcare Limited, we can support studies operating worldwide.
Main duties of the job
An exciting opportunity has arisen for an experienced Quality Manager to support our Clinical Trials division.
A pathology background and experience of quality management are essential.
Must be familiar with Good clinical practice, including the principles of ICH harmonized Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) E6 and (CPMP/ICH/2711/99) E11.
Working closely with the Head of Clinical Trials and Quality Management team, the successful applicant will administer and monitor the quality management system within the Clinical Trials Department
The role will involve hosting client audits and dealing with client queries.
They will also provide quality support for client contract management.
The role will be based at our Core laboratory in Central London but with the occasional requirement to work at other sites as directed
TDL will provide training and competency assessment of the suitable candidate.
Experience of using Q pulse is desirable but not essential
Please read the job description and person specification carefully and ensure that your application reflects the knowledge, skills and experience required.
We respect and value the diversity of our staff and welcome applications from diverse communities.
PLEASE NOTE: WE RESERVE THE RIGHT TO CLOSE THIS VACANCY AT ANY TIME EVEN IF A CLOSING DATE IS SHOWN HERE OR IN ANY OTHER MEDIA
About us
At TDL we offer a variety of excellent staff benefits including:
Training and development opportunities supporting professional development
Annual performance related salary review
** No banding restrictions:**As we are a private company we are not restricted by salary bandings and so are able to negotiate appropriate salaries based on experience. This also means that annual salary reviews do not hit a band ceiling
Discounted gym membership we have a corporate gym membership scheme with Better Gyms
Cash healthcare plan cash back on a variety of healthcare costs including dentist and opticians
Sick Pay Entitlement 5 paid days in the first year of employment, 20 days thereafter
Permanent Health Insurance and Death in Service Cover
Life Assurance providing salary continuation for long term illness (six months qualifying period)
Employee Assistance Programme supporting staff wellbeing
Season Ticket Loan Scheme interest free loan for the cost of annual travel ticket
Perkbox Access to additional staff perks and benefits such as high street discounts
Company Pension Scheme company and staff contributions which increase with service
Competitive annual leave allowance- 23 days
Flexible working hours 40 hours standard working week
Job description
Job responsibilities
TDL Trials offers highly specialised and
regulatory compliant pathology services for single and multicentre Phase I, II
and III clinical trials, safety and pharmacodynamic testing, and
patient-monitoring services to Pharmaceutical, Biotechnology and Research
organisations. We pride ourselves on our ability to offer a bespoke service,
and we are committed to service excellence.
From our
London ISO 15189-accredited
laboratories, TDL supports a wide range of therapeutic areas for organisations
undertaking clinical studies throughout the UK, Europe, Australasia and the
USA. And as we are part of Sonic Healthcare Limited, we can support
studies operating worldwide.
Working closely
with the Head of Clinical Trials and Quality Management team, the successful
applicant will administer and monitor the quality management system within the Clinical Trials Department
The role will
involve hosting client audits and dealing with client queries.
They will also
provide quality support for client contract management.
The role will
be based at our Core laboratory in Central London but with the occasional
requirement to work at other sites as directed
TDL will provide training and competency
of the suitable candidate .
Experience of using Q pulse is desirable but not essential
A background in Pathology is desirable
Must be familiar with Good clinical
practice, including the principles of ICH harmonized Tripartite Guideline for
Good Clinical Practice (CPMP/ICH/135/95) E6 and (CPMP/ICH/2711/99) E11.
Main duties
To include, but not be restricted
to, the following duties:
1.
To
maintain the overall quality policy for TDL as directed
2.
To
ensure that processes required for the Quality Management System are
established, implemented and maintained within the service.
3.
To
provide a Quality Lead and a point of initial contact for quality
guidance and support on day-to-day activities across the service.
4.
To
lead and assist with the establishment and documentation of quality objectives,
including formulating a plan for achieving these objectives for the service and
for the QMG.
5.
To
assist in the preparation, administration, dissemination and regular review of quality
manuals for the service.
6.
To
ensure that the quality management system functions correctly by managing and
maintaining quality monitoring systems.
7.
To
develop and assist in maintaining the document control system for the
service
8.
To
establish processes for recording, investigating, trending and learning from incidents
and complaints within the service
9.
Assistance
with external audit & client visit preparation
10.
Attend
Client meetings when required
11.
To
assist in maintaining the system for control of records for the service
12.
To
participate in the management review procedure for the quality
management system.
13.
To
participate in the ongoing evaluation and improvement processes for the
service
14.
To
engage in activities for measuring performance of the service
15.
To
assist in maintaining systems to facilitate the continuing improvement
in TDL laboratory services
16.
To
ensure all quality procedures are performed in accordance with the relevant Health
and Safety policy and procedures.
17.
To
ensure the promotion of awareness of users needs and requirements
throughout the organisation.
18.
To report
to senior management, at the level at which decisions are made on policy,
objectives, and resources, on the performance of the Quality Management System
and any need for improvement.
19.
To support
Principal Quality Managers and the Director of Governance with other quality
management functions as directed.
Job description
Job responsibilities
TDL Trials offers highly specialised and
regulatory compliant pathology services for single and multicentre Phase I, II
and III clinical trials, safety and pharmacodynamic testing, and
patient-monitoring services to Pharmaceutical, Biotechnology and Research
organisations. We pride ourselves on our ability to offer a bespoke service,
and we are committed to service excellence.
From our
London ISO 15189-accredited
laboratories, TDL supports a wide range of therapeutic areas for organisations
undertaking clinical studies throughout the UK, Europe, Australasia and the
USA. And as we are part of Sonic Healthcare Limited, we can support
studies operating worldwide.
Working closely
with the Head of Clinical Trials and Quality Management team, the successful
applicant will administer and monitor the quality management system within the Clinical Trials Department
The role will
involve hosting client audits and dealing with client queries.
They will also
provide quality support for client contract management.
The role will
be based at our Core laboratory in Central London but with the occasional
requirement to work at other sites as directed
TDL will provide training and competency
of the suitable candidate .
Experience of using Q pulse is desirable but not essential
A background in Pathology is desirable
Must be familiar with Good clinical
practice, including the principles of ICH harmonized Tripartite Guideline for
Good Clinical Practice (CPMP/ICH/135/95) E6 and (CPMP/ICH/2711/99) E11.
Main duties
To include, but not be restricted
to, the following duties:
1.
To
maintain the overall quality policy for TDL as directed
2.
To
ensure that processes required for the Quality Management System are
established, implemented and maintained within the service.
3.
To
provide a Quality Lead and a point of initial contact for quality
guidance and support on day-to-day activities across the service.
4.
To
lead and assist with the establishment and documentation of quality objectives,
including formulating a plan for achieving these objectives for the service and
for the QMG.
5.
To
assist in the preparation, administration, dissemination and regular review of quality
manuals for the service.
6.
To
ensure that the quality management system functions correctly by managing and
maintaining quality monitoring systems.
7.
To
develop and assist in maintaining the document control system for the
service
8.
To
establish processes for recording, investigating, trending and learning from incidents
and complaints within the service
9.
Assistance
with external audit & client visit preparation
10.
Attend
Client meetings when required
11.
To
assist in maintaining the system for control of records for the service
12.
To
participate in the management review procedure for the quality
management system.
13.
To
participate in the ongoing evaluation and improvement processes for the
service
14.
To
engage in activities for measuring performance of the service
15.
To
assist in maintaining systems to facilitate the continuing improvement
in TDL laboratory services
16.
To
ensure all quality procedures are performed in accordance with the relevant Health
and Safety policy and procedures.
17.
To
ensure the promotion of awareness of users needs and requirements
throughout the organisation.
18.
To report
to senior management, at the level at which decisions are made on policy,
objectives, and resources, on the performance of the Quality Management System
and any need for improvement.
19.
To support
Principal Quality Managers and the Director of Governance with other quality
management functions as directed.
Person Specification
Qualifications
Essential
- Good general standard of education, preferably a science degree, or equivalent.
- Formal Quality Qualification is desirable.
Skills and Abilities
Essential
- Excellent written and verbal communication skills.
- Excellent interpersonal skills.
- Ability to work on own initiative and as part of a team.
- Numerate.
- Highly skilled in use of Microsoft Office.
- Experience of utilising statistical analysis software.
- Able to write take minutes and write reports.
- Excellent attention to detail skills.
- Excellent organisational & record keeping skills.
Experience
Essential
- Experience working in a Quality Management role is essential.
- Experience of working within the healthcare field (preferably experience working in a QA / regulatory environment) is desirable.
- Report writing experience.
- Experience of GCP guidelines
Person Specification
Qualifications
Essential
- Good general standard of education, preferably a science degree, or equivalent.
- Formal Quality Qualification is desirable.
Skills and Abilities
Essential
- Excellent written and verbal communication skills.
- Excellent interpersonal skills.
- Ability to work on own initiative and as part of a team.
- Numerate.
- Highly skilled in use of Microsoft Office.
- Experience of utilising statistical analysis software.
- Able to write take minutes and write reports.
- Excellent attention to detail skills.
- Excellent organisational & record keeping skills.
Experience
Essential
- Experience working in a Quality Management role is essential.
- Experience of working within the healthcare field (preferably experience working in a QA / regulatory environment) is desirable.
- Report writing experience.
- Experience of GCP guidelines
Additional information
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).
