Job summary
Senior Research Data Manager
18 months Fixed-Term due to funding
The Research Department is looking for a full time (37.5 hours) Senior Research Data Manager to set-up and manage clinical trial databases for studies sponsored by the Trust, including clinical trials of investigational medicinal products (CTIMPS) conducted at the Trust's Clinical Research Facility (CRF) or other national and international host sites.
Main duties of the job
The postholder will be responsible for planning, delivering and monitoring high quality research data capture for allocated studies in accordance with funder expectations, Trust SOPs, applicable guidelines, country specific regulations and European Union Legislation and Good Clinical Practice (GCP) standards.The role involves the everyday management of research data during the lifetime of allocated research projects as well as making decisions about how data will be preserved and shared after projects are completed.
Senior level experience of managing research data within the NHS, academic or commercial settings will be an essential requirement.The post holder will be required to work with a high level of autonomy. You will also be in contact with a broad professional group, as well as oversight boards and external stakeholders, therefore excellent communication, interpersonal and project management skills will be of equal importance.
The Research Department delivers research across all the Trust sites and our two Clinical Research Facilities and has a sponsor team that sets up and manages a number of sponsored studies, including CTIMPs, multi-centre and international trials. There are over 70 staff in the Department, working closely with CIs and PIs, most of which are clinical academics with an affiliation to our academic partner Imperial College London.
For more information seehttps://www.chelwest.nhs.uk/research
About us
We provide services from two main hospitals, Chelsea and Westminster Hospital and West Middlesex University Hospital, and a number of clinics across London and the South-East.
We have over 6,000 members of staff that are PROUD to Care for nearly one million people. Both hospitals provide full clinical services, including full maternity, emergency and children's, in addition to a range of community-based services across London, such as award-winning sexual health and HIV clinics.
We're one of the safest and best performing Trusts in the country. We're also one of the top trusts to work for - our staff say they're engaged, motivated, and would recommend us as a place to work and receive treatment.
In 2020 Trust was rated by the Care Quality Commission as Outstanding in the well-led and use of resources domains and Good in the safe, effective, caring, and responsive domains. The Trust as a whole was Good, but the Chelsea site was Outstanding.
Our facilities are some of the best in the country. We have been investing around £10 million a year in our estate. We are currently spending £25 million on expanding our adult and neonatal critical care facilities at Chelsea and Westminster and redevelopment of our children's unit at West Middlesex - in partnership with our charity, CW+ and generous donors.
Job description
Job responsibilities
Study set-up and data handling Develop, review and update study specific data definitions, data management plans and data collection guidelines. Define and manage data management timelines on assigned projects. Provide specialist NHS informatics knowledge, advising on existing data sources that can contribute to research planning, feasibility and data management. Make use of a wide range of information sources, including internal and external databases, and professional publications to enhance successful project delivery. Manage the development of clinical trial databases. Develop questionnaires and data collection forms. Contribute to the setup of the trial master files and investigator site files. Develop and maintain an efficient data management system to ensure prompt and accurate processing of trial data. Ensure prompt and efficient response to queries (daily trouble shooting) or contact from recruiting sites, acknowledging all communication, and ensuring efficient flow of information. Lead on the development of research data related operational policies, procedures and training requirements. Lead on the efficient processing, validation and quality assurance of data from various studies. Oversee organization, storage, preservation (archiving and access), and sharing of data collected and used in various studies.
Data quality assurance and monitoring Work to Good Clinical Practice (GCP) guidelines on trial conduct and data management and ensure knowledge is kept updated. Ensure all data handling complies with the General Data Protection Regulation (GDPR); this may entail spot checks and regular audit. Develop and ensure that trial specific data management documentation including Standard Operating Procedures (SOPs) are adhered to. Work with trial teams and database providers to ensure that data management systems are maintained to the highest level of integrity at all times. Implement regular quality controls, with prompt and appropriate responses to incoming data. Ensure efficient discrepancy management and resolution, quality control, data cleaning and validation. Lead on development of action plans to improve data quality. Identify, record and provide solutions to complex data management risks and issues. Assist with business contingency and disaster recovery planning for assigned project. Liaise with the trust information team to ensure local and national policy changes and Information Standards Notices (ISNs) are reflected appropriately in relevant research datasets. Deliver site audits as agreed with trial management teams or steering committees.
Reporting Provide and present timely highlight, exception or data quality reports to relevant boards and committees. Write key study performance reports on project data collection, achievement of targets and quality, risks. Notify and document significant deviations (potential serious breaches) in an expedited fashion (within two days). Be responsible for the development and ongoing management of partnerships with external suppliers of data services, ensuring that all contractual and statutory obligations are met. Ensure contractual obligations are met including safety reporting obligations, provision of documentation, progress reports and report writing.
Education Support research operations team in producing training materials and delivering training to sites. Contribute to the planning and conduct of collaborators meetings. As a senior member in the research operations team, to regularly coach junior staff, prioritise workload and quality assure data related workstreams.
Job description
Job responsibilities
Study set-up and data handling Develop, review and update study specific data definitions, data management plans and data collection guidelines. Define and manage data management timelines on assigned projects. Provide specialist NHS informatics knowledge, advising on existing data sources that can contribute to research planning, feasibility and data management. Make use of a wide range of information sources, including internal and external databases, and professional publications to enhance successful project delivery. Manage the development of clinical trial databases. Develop questionnaires and data collection forms. Contribute to the setup of the trial master files and investigator site files. Develop and maintain an efficient data management system to ensure prompt and accurate processing of trial data. Ensure prompt and efficient response to queries (daily trouble shooting) or contact from recruiting sites, acknowledging all communication, and ensuring efficient flow of information. Lead on the development of research data related operational policies, procedures and training requirements. Lead on the efficient processing, validation and quality assurance of data from various studies. Oversee organization, storage, preservation (archiving and access), and sharing of data collected and used in various studies.
Data quality assurance and monitoring Work to Good Clinical Practice (GCP) guidelines on trial conduct and data management and ensure knowledge is kept updated. Ensure all data handling complies with the General Data Protection Regulation (GDPR); this may entail spot checks and regular audit. Develop and ensure that trial specific data management documentation including Standard Operating Procedures (SOPs) are adhered to. Work with trial teams and database providers to ensure that data management systems are maintained to the highest level of integrity at all times. Implement regular quality controls, with prompt and appropriate responses to incoming data. Ensure efficient discrepancy management and resolution, quality control, data cleaning and validation. Lead on development of action plans to improve data quality. Identify, record and provide solutions to complex data management risks and issues. Assist with business contingency and disaster recovery planning for assigned project. Liaise with the trust information team to ensure local and national policy changes and Information Standards Notices (ISNs) are reflected appropriately in relevant research datasets. Deliver site audits as agreed with trial management teams or steering committees.
Reporting Provide and present timely highlight, exception or data quality reports to relevant boards and committees. Write key study performance reports on project data collection, achievement of targets and quality, risks. Notify and document significant deviations (potential serious breaches) in an expedited fashion (within two days). Be responsible for the development and ongoing management of partnerships with external suppliers of data services, ensuring that all contractual and statutory obligations are met. Ensure contractual obligations are met including safety reporting obligations, provision of documentation, progress reports and report writing.
Education Support research operations team in producing training materials and delivering training to sites. Contribute to the planning and conduct of collaborators meetings. As a senior member in the research operations team, to regularly coach junior staff, prioritise workload and quality assure data related workstreams.
Person Specification
Experience and Skills
Essential
- Educated to degree level
- Qualification in Research Data or Information Management or equivalent
- Experience working with large databases
- Knowledge of regulatory framework for Research
- Substantial experience of managing trial data, incl. CTIMPs
- Advanced IT skills
- Working autonomously
- Excellent communication skills
Desirable
- Setting up EDC / eCRF systems eg. on REDCap, Castor, OpenClinica etc.
- Senior NHS research experience
- PRINCE2 or equivalent project management qualification
Person Specification
Experience and Skills
Essential
- Educated to degree level
- Qualification in Research Data or Information Management or equivalent
- Experience working with large databases
- Knowledge of regulatory framework for Research
- Substantial experience of managing trial data, incl. CTIMPs
- Advanced IT skills
- Working autonomously
- Excellent communication skills
Desirable
- Setting up EDC / eCRF systems eg. on REDCap, Castor, OpenClinica etc.
- Senior NHS research experience
- PRINCE2 or equivalent project management qualification
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).