Senior Research Data Manager

Main area Haematology Grade NHS AfC: Band 5 Contract Fixed term: 12 months (FTC) Hours Full time - 37.5 hours per week (Monday-Friday 9-5pm) Job ref 213-CORP A

Employer King's College Hospital NHS Foundation Trust Employer type NHS Site King's College Hospital NHS Foundation Trust Town London Salary £37,259 - £45,356 per annum, including high cost allowance Salary period Yearly Closing 18/01/:59

King's College Hospital NHS Foundation Trust is one of the UK's largest and busiest teaching Trusts with a turnover of c£1.8 billion, 1.5 million patient contacts a year and more than 15,000 staff based across 5 main sites in South East London. The Trust provides a full range of local hospital services across its different sites, and specialist services from King's College Hospital (KCH) sites at Denmark Hill in Camberwell and at the Princess Royal University Hospital (PRUH) site in the London Borough of Bromley.

We encourage all our staff to have a healthy work/life balance. In doing so, you can apply for flexible working from the beginning of your employment. We offer a range of options which are designed to suit different circumstances and priorities in line with service requirements.

This post will support the delivery of high-quality clinical research within the haematology research unit, covering the Lymphoid and BMT transplant studies. The post holder will be responsible for the coordination, data management, and governance of clinical trials and research studies, ensuring compliance with Good Clinical Practice (GCP), the Medicines for Human Use (Clinical Trials) Regulations, and the Research Governance Framework.

The role involves close collaboration with multidisciplinary teams, patients, and external sponsors to ensure accurate data collection, effective trial management, and adherence to all ethical and regulatory requirements.

Main duties of the job

The post holder will be responsible for data management. The post-holder will play a key role in supporting and leading on a portfolio of observational, commercial and non-commercial haematology clinical trials. Post holder will also be leading on KCH - led registry studies obtaining consent from patients as well as lead on data management on multicentre ATIMP academic studies.

Responsibilities will include completion of case report forms, day to day office management and maintenance of clinical trials documentation, processes and database.

The post holder will work closely with the trial managers, data managers, research nurses, clinical trial coordinators, clinical team and clinical trials sponsors and representatives. Assist with data monitoring and collection from participating sites as well as manage and review standard operating procedures (SOP) to ensure compliance within the team. Attend and participate in trial meetings.

Working for our organisation

The Trust provides a full range of local and specialist services across its five sites. The trust-wide strategy of Strong Roots, Global Reach is our Vision to be BOLD, Brilliant people, Outstanding care, Leaders in Research, Innovation and Education, Diversity, Equality and Inclusion at the heart of everything we do. By being person-centred, digitally-enabled, and focused on sustainability, we aim to take Team King's to another level.

We are at a pivotal point in our history and we require individuals who are ready to join a highly professional team and make a real, lasting difference to our patients and our people.

King's is committed to delivering Sustainable Healthcare for All via our Green Plan. In line with national Greener NHS ambitions, we have set net zero carbon targets of 2040 for our NHS Carbon Footprint and 2045 for our NHS Carbon Footprint Plus. Everyone's contribution is required in order to meet the goals set out in our Green Plan and we encourage all staff to work responsibly, minimising their contributions to the Trust's carbon emissions, waste and pollution wherever possible.

Detailed job description and main responsibilities

1Data Management

• Ensure accurate and timely completion of Case Report Forms (CRFs) according to trial protocol
• Responsible for the collection, coordination and computerisation of data generated from the clinical trials
• Maintain the Trial Master file (TMF) and Investigator Site File (ISF) with essential documents and version control
• Ensure SAEs recorded and reported in accordance with the protocol and/or sponsor's SOP
• Liaise with other departments and wards at the site/s to promote a good working environment, integration of research within and open channels of communication
• Inform appropriate medical personnel and departments of portfolio of clinical trials
• Report adverse incidents and near misses via the Trust's online incident reporting form
• To contribute to the development, review and maintenance of Standard Operating Procedures (SOP)
• Support internal and external monitoring and audit activities related to clinical research
• Uphold the principles of Good Clinical Practice (GCP) and all relevant clinical trial regulations
• Act as a resource and support to patients and their relatives when required
• Obtain Informed consent for registry studies and provide cross site cover as required

2Governance / Quality Control

Work in accordance with all regulatory requirements including:

• Local Standard Operating Procedures
• Good Clinical Practice
• Medicines for Human Use (Clinical Trials) Regulations
• Research Governance Framework for Health and Social Care

Administrative Responsibilities

• Provide comprehensive administrative support for research meetings, including agenda preparation, minute taking, and follow-up actions
• Complete case report forms in a precise and timely manner, ensuring that all the relevant clinical data in the patient's medical notes and trial file is transcribed accurately. To update the Trial Manager /Clinical Trials Coordinator regularly the status of such data
• Assist in preparing and submitting documentation to ethics committees, regulatory authorities and R&D
• Create and maintain the file of current protocols and patient information sheets, ensuring version control. Be responsible for the maintenance of the Investigator Site Files
• Develop, update, and maintain trial-specific databases and electronic worksheets
• Organise and prepare documentation for audit and monitoring visits
• Provide cover when necessary for colleagues during periods of absence

Clinical Responsibilities

• Conduct patient facing activities to include obtaining informed consent for registry studies
• Perform sample processing and shipping
• Carry out basic clinical tasks such as phlebotomy and vital signs

Person specification Essential/Desirable

• Evidence of continuous personal, professional, and academic development
• Knowledge and experience with multidisciplinary team and internal & external stakeholders
• Excellent attention to detail and data accuracy
• Previous experience within haematology oncology; or research
• Understanding of Research Governance and Ethics procedures
• Knowledge of clinical trial activity & ability to relay information to other professionals involved in patient care
• Proficient in database management and Microsoft Office applications
• Analytical Skills
• Data Collection, entry & filing evidence
• Ability to work in a team and flexibility to travel cross site
• Planning & organisational Skills
• Advanced IT skills (ECDL) or equivalent
• Basic clinical Skills; phlebotomy, Vital signs

IMPORTANT

• Check your email account regularly as this is how we will communicate with you
• If you delete the job from any of your accounts, you may be prevented from accessing further communications
• To enquire about your application or inform us of any changes in your circumstances, please contact the named person on this advert
• Please provide email addresses for referees where possible
• Please review the documentation on our recruitment microsite, particularly the Trust's criminal records checking policy
• All staff have a responsibility for safeguarding children and vulnerable adults and for ensuring they are aware of the specific duties relating to their role.
• Please note that the closing date is given as a guide. On occasion, we might close a vacancy early due to a high number of applications being received. You are advised to submit your application as early as possible to avoid disappointment.

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Employer certification / accreditation badges

This post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service.