Job summary
The clinical Research Facility (CRF) is looking for a Band 5 Research Data Manager on a Full time basis (37 hours per week).
The CRF is a Phase 1 MHRA accredited unit, the first NHS trust in England and Wales to achieve this standard.
The role of the Research Data Manager will involve working on a number of CRF clinical trials and studies, across multiple disciplines, in order to ensure high quality clinical data is captured. The Research Data Manager will support with the coordination of Data Management Activity across the CRF Data Team. Joining the CRF is a fantastic opportunity to be part of a dynamic and growing team that is dedicated to delivering high quality Phase 1 research.
The data collected in these studies is used to assess safe and effective new therapies or treatment options are for a wide range of diseases.
(This is an office-based role, working at the Clinical Research Facility in the Royal Liverpool Hospital.)
Main duties of the job
The post holder will support the Senior Research Data Manager in performing Data Management Activity and coordinating this work across the Data Team. This includes entry of data from source, resolution of queries, and QC of data within Sponsor driven timelines, and key study milestones. The role will involve the use of various Clinical Databases (iMedidata/RAVE, REDCAP, CASTOR etc.) for the completion of eCRFs for studies of varying disease types.
For the set up of new studies, the Research Data Manager will be required to assist in the development of User Testing Scripts for new databases, key DM documents (Data Management Plans, eCRF completion guidance) and contributing to study meetings in place of the Senior Research Data Manager (SRDM). Acting as a QC for the design of new database builds is also a requirement, and so a working knowledge of the use of Database software for eCRF development is desirable.
Within the CRF you will have an opportunity to work within a multi-disciplinary team including Clinical, Medical, Laboratory, Project Management and Recruitment teams. The Core data team is expanding and includes Data Officers and a Senior Research Data Manager.
About us
Liverpool University Hospitals NHS Foundation Trust was created on 1 October 2019 following the merger of two adult acute Trusts, Aintree University Hospital NHS Foundation Trust and the Royal Liverpool and Broadgreen University Hospitals NHS Trust.
The merger provides an opportunity to reconfigure services in a way that provides the best healthcare services to the city and improves the quality of care and health outcomes that patients experience.
The Trust runs Aintree University Hospital, Broadgreen Hospital, Liverpool University Dental Hospital and the Royal Liverpool University Hospital.
It serves a core population of around 630,000 people across Merseyside as well as providing a range of highly specialist services to a catchment area of more than two million people in the North West region and beyond.
To hear more about our achievements click herehttps://www.liverpoolft.nhs.uk/media/13089/1606-annual-report-booklet_final.pdf
Follow us on Social Media:
Facebook - Liverpool University Hospitals Careers
Instagram - @LUHFTcareers
Twitter - @LUHFTcareers
Job description
Job responsibilities
- Data Entry, Query Resolution and QC of Clinical Data in to study specific Databases.
- Support in coordinating and tracking DM activity within the CRF Data Team.
- Perform Data Cleaning of study datasets via manual review, fired validations and data clarification/Queries.
- Monitor trends in DM activity timelines in order to maintain compliance and improve efficiency.
- Report on DM progress across the CRF study portfolio, along with resources and capacity to maintain service delivery.
- Monitor compliance of DM activity to Trust/CRU standard operating procedures and guidelines.
- Perform User Acceptance Testing for new databases and updates to eCRFs prior to roll out for live data collection.
- Identify patterns in data cleaning issues in order to manage and prevent recurrence.
Job description
Job responsibilities
- Data Entry, Query Resolution and QC of Clinical Data in to study specific Databases.
- Support in coordinating and tracking DM activity within the CRF Data Team.
- Perform Data Cleaning of study datasets via manual review, fired validations and data clarification/Queries.
- Monitor trends in DM activity timelines in order to maintain compliance and improve efficiency.
- Report on DM progress across the CRF study portfolio, along with resources and capacity to maintain service delivery.
- Monitor compliance of DM activity to Trust/CRU standard operating procedures and guidelines.
- Perform User Acceptance Testing for new databases and updates to eCRFs prior to roll out for live data collection.
- Identify patterns in data cleaning issues in order to manage and prevent recurrence.
Person Specification
Education/Qualification
Essential
- Educated to Degree standard or equivalent experience. A bachelor's or master's degree in life science or health-related fields or equivalent experience.
Knowledge, Training and Experience
Essential
- Experience of using current Clinical Trial Databases.
- Experience in the use of Clinical Trial Databases for raising queries/data clarification.
- Experience in writing Data Management Plans and eCRF completion guidance documents.
- Experience in eCRF/Database versioning and change control process.
- Awareness of the implementation of ICH-GCP and MHRA Data integrity guidance as it applies to Data Management, eCRF development and the use of Clinical Trial Databases.
- Relevant experience, ideally of working in the health service and/or research environment.
- Comprehensive IT Skills, including Microsoft Office, TEAMS, and SharePoint
Desirable
- Experience in the development of eCRFs using Clinical Database software.
- Experience of supervising Data Entry Delegates in the completion of eCRFs and resolution of data queries ahead of key study targets.
- Awareness of the process of creating database extracts and the downstream statistical analysis/programming techniques that are used in clinical trials.
- Understanding of CDASH and CDISC standards, and the implementation of SDTM in database design and reporting.
Planning and Organising
Essential
- Excellent Organisation Skills.
- Evidence of an ability to prioritise workload, manage time effectively and meet tight deadlines.
Freedom to Act
Essential
- Well-motivated with evidence of an ability to work without direct supervision and to use own initiative.
- Ability to exercise independence and judgement in the arrangement of administrative work across a complex organisational structure, albeit within laid down policy and procedures.
Communication and Relationship Skills
Essential
- Excellent communication and interpersonal skills.
- Ability to develop and maintain excellent working relationships with Clinical and Non-Clinical Staff.
- Ability to communicate technical data issues effectively to both data and non-data team members.
- Ability to set up and participate in meetings with both internal and external representatives.
Desirable
- Ability to produce training materials and SOPs for the management of clinical trial data.
Skills and Abilities
Essential
- Excellent attention to detail
- Able to work under pressure, meet deadline and manage own work priority.
- Highly professional approach to work, in particular in dealing with confidential information.
- Effective time management skills.
Person Specification
Education/Qualification
Essential
- Educated to Degree standard or equivalent experience. A bachelor's or master's degree in life science or health-related fields or equivalent experience.
Knowledge, Training and Experience
Essential
- Experience of using current Clinical Trial Databases.
- Experience in the use of Clinical Trial Databases for raising queries/data clarification.
- Experience in writing Data Management Plans and eCRF completion guidance documents.
- Experience in eCRF/Database versioning and change control process.
- Awareness of the implementation of ICH-GCP and MHRA Data integrity guidance as it applies to Data Management, eCRF development and the use of Clinical Trial Databases.
- Relevant experience, ideally of working in the health service and/or research environment.
- Comprehensive IT Skills, including Microsoft Office, TEAMS, and SharePoint
Desirable
- Experience in the development of eCRFs using Clinical Database software.
- Experience of supervising Data Entry Delegates in the completion of eCRFs and resolution of data queries ahead of key study targets.
- Awareness of the process of creating database extracts and the downstream statistical analysis/programming techniques that are used in clinical trials.
- Understanding of CDASH and CDISC standards, and the implementation of SDTM in database design and reporting.
Planning and Organising
Essential
- Excellent Organisation Skills.
- Evidence of an ability to prioritise workload, manage time effectively and meet tight deadlines.
Freedom to Act
Essential
- Well-motivated with evidence of an ability to work without direct supervision and to use own initiative.
- Ability to exercise independence and judgement in the arrangement of administrative work across a complex organisational structure, albeit within laid down policy and procedures.
Communication and Relationship Skills
Essential
- Excellent communication and interpersonal skills.
- Ability to develop and maintain excellent working relationships with Clinical and Non-Clinical Staff.
- Ability to communicate technical data issues effectively to both data and non-data team members.
- Ability to set up and participate in meetings with both internal and external representatives.
Desirable
- Ability to produce training materials and SOPs for the management of clinical trial data.
Skills and Abilities
Essential
- Excellent attention to detail
- Able to work under pressure, meet deadline and manage own work priority.
- Highly professional approach to work, in particular in dealing with confidential information.
- Effective time management skills.
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
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).
