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Clinical Trials Data Validator (86975)
| Posting date: | 23 September 2024 |
|---|---|
| Salary: | £27,979.00 to £32,332.00 per year |
| Additional salary information: | 27979 - 32332 |
| Hours: | Full time |
| Closing date: | 07 October 2024 |
| Location: | Liverpool, L3 5QA |
| Company: | Vacancy Filler |
| Job type: | Permanent |
| Job reference: | SEP20241248 |
Summary
Salary: £ 27,979 - £32,332 p.a. (starting salary will be £27,979 p.a.)
Full-time, permanent appointment
Based in Liverpool
Liverpool School of Tropical Medicine (LSTM) is at the forefront of global health, working on groundbreaking clinical trials that aim to improve health outcomes worldwide. Our Global Health Unit is committed to advancing public health by ensuring the highest standards in clinical research and data integrity.
We are seeking a meticulous and experienced Clinical Trials Data Validator to join our dynamic Global Health Trial Unit (GHTU). You will play a vital role in ensuring the precision, dependability, and functionality of software systems and applications integral to clinical research and data management. This role demands a strong understanding of system validation principles, regulatory mandates, and quality assurance protocols. The validator will undertake the validation of projects and systems hosted at LSTM, supporting the delivery of research in accordance with applicable standards and practices
The successful candidate will work in close partnership with the GHTU and teams in accredited laboratories in close communication with Chief/Principal Investigators and will be involved in all aspects of data and systems validation processes, including development of documentation, database testing, software testing, supporting data collection and validation, delivering training, data administration, archiving and sharing.
Key responsibilities include:
General Validation:
Monitor and maintain the validation status of compliant software systems
Test and validate reports, extracts, and data presentations
Reconciliation of data from external sources and relational databases
Support validation testing activities
Provide support for system implementation, upgrades, and changes,
Documenting validation activities, in compliance with standard operating procedures (SOPs) and validation guidelines.
Study Involvement
Complete database testing and validation for new trial databases and database changes
Draft project specific validation documentation for trials
Perform QC checks (including spot checks) and Database Quality Assessments on the clinical databases of projects
Monitor data for consistency and acceptability using data management software
Unit Support GHTU and LITE
Assist in the preparation or review of validation documentation
Assist in reviewing practices to ensure compliance with OECD and MHRA Good Laboratory (or Good Clinical) Practice standards
Support team members in the production and delivery of training packages
Support in maintaining internal data management procedures and ensure all processes are appropriately documented.
The ideal candidate will possess the following:
Evidence of training in Good Clinical Practice/ Good Laboratory Practice
Experience of working in clinical trials, with particular experience of working with clinical data
Experience of quality control or validation in a clinical trials environment
An understanding of clinical trial data management
Experience of transferring data between different software packages
Good computer skills, experience with MS office packages, database software
(For a full list of essential and desirable criteria please refer to the job description and person specification)
In return we offer:
30 days annual leave, plus bank holidays, and additional Christmas closure days
Generous occupational pension schemes
Government backed “cycle to work” scheme
Affiliated, discounted staff membership to the University of Liverpool Sports Centre
Plus, a host of additional family friendly policies
If you are passionate about ensuring the highest standards of data quality and system integrity in clinical trials, we want to hear from you.
Informal enquiries can be made to: jim.read@lstmed.ac.uk
Closing Date: 7<sup>th</sup> October 2024
Application Process: To apply for the position please click on the apply link and upload your CV and covering letter.
Due to the volume of applications, we receive, we may close our vacancies early. It is therefore advisable to apply as early as possible if you would like to be considered for the role.
Inclusion is central to our values at LSTM
We seek to attract and recruit people who reflect the diversity across our communities, regardless of sexual orientation, gender identity, ethnicity, nationality, faith or belief, social background, age and disability. LSTM selects candidates based on skills, qualifications, and experience.
We welcome conversations about flexible working; and applications from those returning to employment after a break from their careers.
About LSTM
Founded in 1898 and the oldest of its kind in the world, the Liverpool School of Tropical Medicine (LSTM) is an internationally recognised centre of excellence for teaching and research in tropical diseases. Through the creation of effective links with governments, NGOs, private organisations and global institutions and by responding to the health needs of communities, LSTM aims to promote improved health, particularly for people of the less developed/resource poorest countries in the tropics and sub-tropics.
Look at some of the great work we have achieved over the past year by viewing our annual report:
https://www.lstmed.ac.uk/about/annual-reports-and-financial-statements
LSTM actively promotes Equal Opportunities and Safeguarding Policies
Full-time, permanent appointment
Based in Liverpool
Liverpool School of Tropical Medicine (LSTM) is at the forefront of global health, working on groundbreaking clinical trials that aim to improve health outcomes worldwide. Our Global Health Unit is committed to advancing public health by ensuring the highest standards in clinical research and data integrity.
We are seeking a meticulous and experienced Clinical Trials Data Validator to join our dynamic Global Health Trial Unit (GHTU). You will play a vital role in ensuring the precision, dependability, and functionality of software systems and applications integral to clinical research and data management. This role demands a strong understanding of system validation principles, regulatory mandates, and quality assurance protocols. The validator will undertake the validation of projects and systems hosted at LSTM, supporting the delivery of research in accordance with applicable standards and practices
The successful candidate will work in close partnership with the GHTU and teams in accredited laboratories in close communication with Chief/Principal Investigators and will be involved in all aspects of data and systems validation processes, including development of documentation, database testing, software testing, supporting data collection and validation, delivering training, data administration, archiving and sharing.
Key responsibilities include:
General Validation:
Monitor and maintain the validation status of compliant software systems
Test and validate reports, extracts, and data presentations
Reconciliation of data from external sources and relational databases
Support validation testing activities
Provide support for system implementation, upgrades, and changes,
Documenting validation activities, in compliance with standard operating procedures (SOPs) and validation guidelines.
Study Involvement
Complete database testing and validation for new trial databases and database changes
Draft project specific validation documentation for trials
Perform QC checks (including spot checks) and Database Quality Assessments on the clinical databases of projects
Monitor data for consistency and acceptability using data management software
Unit Support GHTU and LITE
Assist in the preparation or review of validation documentation
Assist in reviewing practices to ensure compliance with OECD and MHRA Good Laboratory (or Good Clinical) Practice standards
Support team members in the production and delivery of training packages
Support in maintaining internal data management procedures and ensure all processes are appropriately documented.
The ideal candidate will possess the following:
Evidence of training in Good Clinical Practice/ Good Laboratory Practice
Experience of working in clinical trials, with particular experience of working with clinical data
Experience of quality control or validation in a clinical trials environment
An understanding of clinical trial data management
Experience of transferring data between different software packages
Good computer skills, experience with MS office packages, database software
(For a full list of essential and desirable criteria please refer to the job description and person specification)
In return we offer:
30 days annual leave, plus bank holidays, and additional Christmas closure days
Generous occupational pension schemes
Government backed “cycle to work” scheme
Affiliated, discounted staff membership to the University of Liverpool Sports Centre
Plus, a host of additional family friendly policies
If you are passionate about ensuring the highest standards of data quality and system integrity in clinical trials, we want to hear from you.
Informal enquiries can be made to: jim.read@lstmed.ac.uk
Closing Date: 7<sup>th</sup> October 2024
Application Process: To apply for the position please click on the apply link and upload your CV and covering letter.
Due to the volume of applications, we receive, we may close our vacancies early. It is therefore advisable to apply as early as possible if you would like to be considered for the role.
Inclusion is central to our values at LSTM
We seek to attract and recruit people who reflect the diversity across our communities, regardless of sexual orientation, gender identity, ethnicity, nationality, faith or belief, social background, age and disability. LSTM selects candidates based on skills, qualifications, and experience.
We welcome conversations about flexible working; and applications from those returning to employment after a break from their careers.
About LSTM
Founded in 1898 and the oldest of its kind in the world, the Liverpool School of Tropical Medicine (LSTM) is an internationally recognised centre of excellence for teaching and research in tropical diseases. Through the creation of effective links with governments, NGOs, private organisations and global institutions and by responding to the health needs of communities, LSTM aims to promote improved health, particularly for people of the less developed/resource poorest countries in the tropics and sub-tropics.
Look at some of the great work we have achieved over the past year by viewing our annual report:
https://www.lstmed.ac.uk/about/annual-reports-and-financial-statements
LSTM actively promotes Equal Opportunities and Safeguarding Policies