Job summary
The NIHR UCLH Clinical Research Facility UCLH is a well-established Clinical Research Facility (CRF) covering two sites. The Leonard Wolfson Experimental Neurology Centre is a dedicated neuroscience experimental medicine facility at the National Hospital for Neurology and Neurosurgery (NHNN) at Queen Square (QS); and the NIHR UCLH Clinical Research Facility is a comprehensive Cancer and Medical research facility on the Bloomsbury campus (BC) at Tottenham Court Road.
We are looking to recruit a self-motivated and enthusiastic Data Manager to work in the CRF and be specifically responsible for the management of a portfolio of clinical trials in the CRF. The job role will be working across all therapeutic areas from first-into-human through to complex and innovative phase 3 trials, and experimental non-IMP studies.
The post holder will be expected to ensure high quality data in line with the study protocol, the principles of Good Clinical Practice (GCP) and the UK Medicines for Human Use (Clinical Trials) Regulations.
The post holder will be based at UCLH CRF based across two CRF sites as required and based on needs
Main duties of the job
- Collect and enter data into electronic or paper Case Report Forms (CRF) from source data files and medical records, following trial specific instructions for data entry
- Liaise with Clinical Research Associates (CRAs) to ensure all outstanding issues and queries are resolved in a timely and efficient manner, with particular attention to data locks
- Manage the maintenance of the Investigator Site Files (ISF), ensuring all essential documents are filed contemporaneously
- Lead preparation and facilitation of monitoring visits with external sponsors
- Work with the research team to prepare and review study documentation in preparation for Audit and Regulatory Inspection
- Deliver training to new starters
About us
University College London Hospitals NHS Foundation Trust (UCLH) is one of the most complex NHS trusts in the UK, serving a large and diverse population. We provide academically led acute and specialist services, to people from the local area, from throughout the United Kingdom and overseas. Our vision is to deliver top-quality patient care, excellent education, and world-class research.
We provide first-class acute and specialist services across eight sites:
We are dedicated to the diagnosis and treatment of many complex illnesses. UCLH specialises in women's health and the treatment of cancer, infection, neurological,gastrointestinaland oral disease. It has world class support services including critical care, imaging, nuclearmedicineand pathology.
We are committed to sustainability and have pledged to become a carbon net zero health service, embedding sustainable practice throughout UCLH. We have set an ambitious target of net zero for our direct emissions by 2031 and indirect emissions by 2040.
Job description
Job responsibilities
For the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description.
Come and be a part of the best NHS trust in England to work for, according to our staff*
UCLH top trust to work at in England for the second year running! : University College London Hospitals NHS Foundation Trust
*In the most recent NHS staff survey UCLH had the highest percentage of staff who said they would recommend us as a place to work, out of all general acute or acute/community NHS trusts in England for the second year in a row.
UCLH top trust to work at in England for the second year running! University College London Hospitals NHS Foundation Trust.
Once again, UCLH has received the highest score of all general acute and acute/community NHS trusts in England for staff that would recommend us as a place to work.
To discover more about what makes UCLH a great place to work, visit: Why Choose UCLH?
Job description
Job responsibilities
For the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description.
Come and be a part of the best NHS trust in England to work for, according to our staff*
UCLH top trust to work at in England for the second year running! : University College London Hospitals NHS Foundation Trust
*In the most recent NHS staff survey UCLH had the highest percentage of staff who said they would recommend us as a place to work, out of all general acute or acute/community NHS trusts in England for the second year in a row.
UCLH top trust to work at in England for the second year running! University College London Hospitals NHS Foundation Trust.
Once again, UCLH has received the highest score of all general acute and acute/community NHS trusts in England for staff that would recommend us as a place to work.
To discover more about what makes UCLH a great place to work, visit: Why Choose UCLH?
Person Specification
Knowledge and Qualifications
Essential
- Science related degree or equivalent experience
- Knowledge of drug development process and concept of clinical trials
- Knowledge of ICH GCP
Experience
Essential
- Experience of working with clinical trials
- Experience of dealing with confidential information
Values
Essential
- Demonstrate ability to meet Trust Values of safety, kindness, teamwork and improving
Communication
Essential
- Ability to communicate effectively verbally and in writing
Skills and Abilities
Essential
- Able to prioritise tasks and work flexibly and effectively under pressure to meet essential
- Ability to work under minimal supervision
- Ability to work as part of a team
- Ability to prioritise own workload
- Ability to work on own initiative
- Excellent computer skills, including experience of Word, Excel and databases
- Ability to communicate effectively verbally and in writing
Personal and People Development
Essential
- Good eye for detail
- Displays desire for professional and personal development
Specific Requirements
Essential
- Willingness to work flexible hours on occasion
Person Specification
Knowledge and Qualifications
Essential
- Science related degree or equivalent experience
- Knowledge of drug development process and concept of clinical trials
- Knowledge of ICH GCP
Experience
Essential
- Experience of working with clinical trials
- Experience of dealing with confidential information
Values
Essential
- Demonstrate ability to meet Trust Values of safety, kindness, teamwork and improving
Communication
Essential
- Ability to communicate effectively verbally and in writing
Skills and Abilities
Essential
- Able to prioritise tasks and work flexibly and effectively under pressure to meet essential
- Ability to work under minimal supervision
- Ability to work as part of a team
- Ability to prioritise own workload
- Ability to work on own initiative
- Excellent computer skills, including experience of Word, Excel and databases
- Ability to communicate effectively verbally and in writing
Personal and People Development
Essential
- Good eye for detail
- Displays desire for professional and personal development
Specific Requirements
Essential
- Willingness to work flexible hours on occasion
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
University College London Hospitals NHS Foundation Trust
Address
NIHR UCLH Clinical Research Facility (CRF)
4th Floor, 170 Tottenham Court Road
London
W1T 7HA
Employer's website
https://www.uclh.nhs.uk (Opens in a new tab)
