Biobank Data Manager
Biobanking of biological samples donated by patients is an important resource which is central to the Medical Research. Informed consent is obtained from patients whereby additional or surplus biological material is donated, processed, stored and then released to research scientists for specific, ethically-approved research projects. The King's College Denmark Hill Haematology Biobank (KCDHH) is based at the Rayne Institute in King's College London (KCL)'s Denmark Hill Campus and collects bone marrow, blood and other tissue samples from patients treated in the Department of Clinical Haematology at King's College Hospital (KCH), and from surplus tissues collected from the South East Haematology Molecular Diagnostics Service (SE-HMDS). In addition to documentation of the informed consent process, biobanking of de-personalised samples should be accompanied by collection of detailed clinical information which is vital for use in research. As the biobank has expanded in its activities, it is now undergoing a process of updating its administrative and data collection processes, including establishing an online clinical and sample database, with electronic records of consent and clinical diagnostic test information.
This new post is for a Data Manager who will have responsibility for setting up a REDCap clinical database that is suitable for a variety of haematological diseases, importing data from historical data collections and implementing a system for regular clinical data updates. The Data Manager will be responsible for the day to day running of data collection and clinical data governance procedures. The post holder will be a graduate with a Healthcare, Science or Management background. Prior experience of databases and excellent IT skills are required. Knowledge and experience of healthcare data and systems would be advantageous. We are seeking an individual who has a keen interest in being part of clinical research. The post holder will work closely with a team ofthe dedicated Biobank Laboratory team led by Ms Rajani Chelliah, as well as with Clinicians, Clinical Scientists and Cclinical Biomedical Scientists. The Biobank Laboratory team oversees receipt, processing, storage and release of samples, and the documentation which is necessary to ensure HTA licence compliance with regards to consent, sample data protection, sample quality and sample tracking. The post holder will have access to confidential clinical data systems, and therefore must have an excellent understanding of issues around data confidentiality and data governance.
The post holder will be directly supervised by Drs Lynn Quek and Piers Patten who are Clinician Scientists and members of the Biobank Governance Committee . Dr Quek is also the Chief Investigator of the Biobank. The postholder will work with both the Governance and Operational Committees of the Biobank, organise, and prepare necessary documentation for regular Committee meetings. The post holder will be the main point of contact for applicants and administer the access application process for access to samples infor the biobank, and be responsible for handling documentation including initiating material transfer agreements (MTAs). The post holder will also be required to play a lead role, with the Biobank Laboratory team manager, in preparing documentation for amendments to standard operating protocols procedures (SOPs) of the biobank, and any amended or new applications to Research Ethics Committees (RECs). Details of the post holder's roles are set out below.
This post will be offered on an a fixed-term contract for 12 months.
This is a full-time post - 100% full time equivalent.
- Provide day-to-day data administration of the KCDHH biobank. This includes ensuring that clinical annotation of banked samples are complete and up to date using a REDCap database.
- Under guidance of the Biobank Access sub-committee, identify suitable biobanked samples for research to be released to researchers, oversee the authorised and safe transfer of anonymised clinical data to researchers, and liaise with the Biobank laboratory for safe and efficient transfer of samples to researchers.
- Be proficient in using the online Biobank clinical database, and liaise with in-house data scientists and external database providers.
- Liaise with IT colleagues to maintain the database, and when appropriate, update the design of the clinical database according to the needs of the Biobank
- Lead on preparation of financial reports, management of invoices and contracts related to database maintenance and development. In conjunction with the Biobank leadership, ensure appropriate contracts are in place for the conduct of database and data collection work with external parties.
- Work with Biobank leadership to ensure financial sustainability of the Biobank. This may include gathering data on Biobanking costs, preparing business plans and liaising with external parties to obtain quotes.
- Ensure compliance with KCL and NHS research and data governance policies.
- Provide advice and support to other staff members with regard to the Biobank database, Biobank and research governance and conduct.
- Maintain strong relationships and good communication with other key personnel and stakeholders in the Biobank, including Biobank scientists, Clinicians, Clinical Scientists, Biomedical Scientists and Researchers.
- Maintain knowledge of Biobank governance issues and an understanding of national and local policies.
- Organise and attend the Governance Committee and biobank subcommittee (Operational and Access) meetings.
- Generate data reports on request from Biobank committees, and if appropriate, perform basic analysis of these data (e.g. biobank activity, patient recruitment)
- Under guidance of the Biobank leadership, prepare reports and manuscripts to share progress with funders, collaborators and wider public.
- In consultation with the Biobank leadership, take the lead in the development of standard operational procedures (SOPs), or updated protocol amendments for non-laboratory aspects of the biobank Biobank.
- Assist in gaining regulatory and ethical approval for future protocol amendments, including submission of Ethics Committee applications.
- In consultation with Drs Quek and Patten, attend national and international meetings as required, which will provide opportunities to build networks with researchers and other Biobanks.
- Under the guidance of Drs Quek and Patten, take part in research projects involving biobanked samples. This may include analysis of patient recruitment and clinical data.
- Be involved with research development of data collection methodology, especially in the field of clinical data collection systems.
- Keep up-to-date with National, NHS andKCL policies of data governance and management to ensure timely effective implementation of changes.
- Attend relevant courses, meetings and conferences.
- Contribute to the development and improvement of the Biobank.
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.
Skills, knowledge, and experience
- Bachelor degree in Healthcare/ Science/ Management -related subject or relevant equivalent experience.
- Knowledge / skills/ technical experience/ personal characteristics
- Experience of database design, development and data governance
- The ability to work independently and as part of a team, to organise, plan and manage a wide range of tasks.
- Excellent IT skills, including intermediate/ advanced knowledge of MS Office applications e.g Excel, Access, Word, Power Point.
- Demonstrate effective organisational and problem solving skills.
- Flexibility to prioritise and manage multiple demands whilst working to changing priorities and tight deadlines.
- Excellent interpersonal and communication skills including ability to write SOPs and reports as required.
- Ability to follow the KCL safety guidelines and adhere to risk assessments and COSHH regulations
- Well-developed statistical skills, with the ability to perform statistical analysis
- Knowledge of Research Ethics Committee (REC) processes.
- Current working knowledge of Data Protection Act (1998), ICH GCP, GCLP, Research Governance, Human Tissue Act (2004) and other key regulatory areas and ethical frameworks.
- Experience in audits and inspections.
- Experience of management of Biobanks, research studies or clinical trial.
This post is subject to Disclosure and Barring Service and Occupational Health clearance.