BMT Data Manager

Job overview

The post holder will be responsible for collecting, auditing and reporting detailed clinical data relating to cellular therapies. These include adult autologous and allogeneic BMT (blood and bone marrow transplant) and CAR-T (chimeric antigen receptor T-cell) patients. The data are used for internal auditing and research but also transferred to the British, European and International BMT Registries.

Blood and Bone Marrow Transplantation (also known as Stem Cell Transplantation) is a specialised service and subject to benchmarking and intense regulatory accreditation and inspection by the Human Tissue Authority (HTA) and the Medicines and Healthcare products Regulatory Agency (MHRA). Reporting accurate and complete stem cell treatment data to the registries is mandatory for JACIE (Joint Accreditation Committee ISCT-Europe & EBMT) accreditation. In turn JACIE accreditation is required for reimbursement of BMT activity form NHS England.

Main duties of the job

The post holder is also responsible for sending regular data updates to NHS England (3 monthly) regarding key BMT outcomes which are benchmarked against other UK transplant centres and communicating the results of the benchmarking to our wider transplant team. The post holder will be responsible for managing in-house databases of the BMT/CAR-T data for the purposes of registry reporting, outcomes analyses, research and audits. The post holder will contribute to data analyses as required, meet deadlines and participate in on-site inspections from relevant accreditation bodies.

Detailed job description and main responsibilities

Key Results Areas

• Management of medical data and databases
• Data reporting
• Audit and data analysis
• Communication

Data Management Responsibilities

• To have a thorough understanding of the process of BMT and other cellular therapies and of their complications and varying outcomes, so as to work semi-independently to collect accurate data and to fulfil the necessary reporting to external agencies.
• To maintain accurate, complete and up to date data in the in-house Microsoft Access databases for stem cell patients (adult autologous and allogeneic BMT and CAR-T patients, or any introduction to new novel treatments related to BMT). This includes information relating to disease, baseline, treatment, complications (such as infection and GVHD), outcomes (such as relapse and survival) and long term follow up data. This also includes information relating to subsequent infusions such as top-ups, DLI, MSC and CTL infusions.
• To function autonomously to manage his/her caseload of data management within a multidisciplinary team
• To collect relevant specialist clinical and laboratory data relating to the BMT and CAR-T patients from a variety of sources including but not limited to; patient notes and correspondence (electronic or hard copy), hospital results systems and other departmental documents (e.g. Apheresis documentation).
• To verify patient consent for registry reporting and keep a record of patients’ decision to give or withhold consent.
• To comply with the Data Protection Act 2018, GDPR 2016 and Trust information governance policies when collecting, storing and reporting data.
• To develop and maintain spreadsheets, datasets and systems that monitor the department's compliance against quality standards and escalating problems identified as appropriate.
• Keep records of stem cell storage in NHS BT Southampton and Royal Marsden facilities and provide discard forms whenever it is required.
• To report all BMT/CAR-T data as described above at D0, D100, D180 and annual follow up to the relevant transplant registries (EBMT/BSBMTCT and CIBMTR) via the registries’ secure electronic data entry platforms, using the relevant DCF (Data Collection Forms).
• To report Annual Activity Survey data to EBMT.
• To submit quarterly BMT metrics data to the NHS England SSQD (Specialised Services Quality Dashboards) platform and report the published data back to the department.
• To provide data and prepare documentation in preparation for onsite inspection by external accreditation bodies, e.g. JACIE and HTA (Human Tissue Authority). Participation in the inspection days.
• To respond to external ad-hoc BMT and donor registry queries and provide data for additional EBMT and BSBMTCT studies.
• To respond to internal requests for BMT data for quality, activity, audit, finance and research purposes.
• To meet deadlines for data submission for external Benchmarking Reports e.g. the BSBMTCT Annual Centre Report and the EBMT Benchmarking Report.
• To request information from other hospitals when necessary.
• To maintain an archive of historical hard copy BMT documents e.g. protocols and consent.
• To use statistical software packages such as SPSS and GraphPad to assist with outcomes analyses (e.g. Kaplan-Meier survival curves) for both research and internal audit.

Administrative and Management

• To always work according to the regulations as described in GESH Good Clinical Practice and GDPR guidelines when dealing with personal information.
• Provide upon request to the finance department activity and activity predictions for forecasting purposes
• To perform audits within the department for both the HTA and JACIE audit schedules and present the findings in the Quality Meetings.
• To review and update the departmental BMT Data Management SOP. To contribute to any other SOPs or similar departmental quality documents which have sections relevant to the Data Management Team.
• To participate in the Quality Meetings by presenting audit findings and other relevant BMT outcomes e.g. monthly Mortality Reports, SSQD data, Annual Benchmarking etc.
• To maintain administrative documentation such as contracts/data agreements with the registries.

Education & Training

• To keep up to date with all Trust mandatory training.
• To maintain familiarity with hospital electronic systems and relevant departmental documentation (e.g. Cerner, consent forms, SOPs and BMT and Apheresis etc.)
• To maintain knowledge of the relevant medical terminology, tests, diseases, complications and medications to enable accurate and detailed BMT/CAR-T data collection and reporting.
• To attend internal meetings such as the BMT In-patient Meetings and the Quality Meetings.
• To attend relevant external conferences, meetings and training days (e.g. EBMT, ASH and BSBMTCT training days).
• To assist in the training and support of newly recruited BMT data management staff and to give informal teaching sessions to other colleagues when required.
• To maintain awareness of current advances in BMT and CAR-T treatments, research and governance to maintain high standards within the data management team.
• To maintain an awareness of changes within the Health Service and the implications of these for research staff.