Biobank Manager

at  Oxford University Hospitals NHS Foundation Trust

The main purpose of the HaemBio Biobank is to collect and store samples from patients with Haematological malignancies. These samples will be made available for high quality research to improve our understanding of, and to develop potential new therapeutic strategies for blood cancers. HaemBio is an expansion of the highly successful MDSBio Study, which has recruited over 8000 patients since its inception in 2006. Samples from MDSBio have contributed to publication of several high-profile peer-reviewed scientific papers which have advanced our understanding of the biology and the treatment of Acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS). HaemBio has now built on MDSBio and has extended to include patients with other blood cancers such as myeloma and lymphoma.

• Oversee and review protocol amendments, applications to REC, HTA and other organizations before they are submitted to the Sponsor/R&D.
• Providing day-to-day management, you will oversee and coordinate the administrative activities involved in HaemBio Biobank. It requires excellent communication, organisational and planning skills. You will be a member of the Biobank Governance Committee which will have oversight of the running of the Biobank.
• Maintain oversight of Biobank Master File ensuring that the studies are conducted in compliance with all Biobank SOPs and conducted to the standards outlined by the relevant British and EU laws, regulations and guidelines.
• You will be expected to liaise with our Tissue Collection Centres on a day-to-day basis and to organise Governance meetings to ensure compliance with quality measures and established standard operating protocols, in accordance with policies of the sponsors of the Biobank.
• Manage and conduct regular audits to ensure compliance with HTA requirements.
• You will work with local investigators at Tissue Collection Centres and report to Prof Paresh Vyas, who is the Chief investigator for the Biobank. You will be the central point of contact for researchers applying to the Biobank for access to patient samples and data.
• You will maintain systems and processes that ensure high standards are maintained and that the core purpose of the Biobank is met.

Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research. The Trust comprises four hospitals - the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury. For more information on OUH please view OUH At a Glance by OUHospitals - Issuu
Our values, standards and behaviours define the quality of clinical care we offer and the professional relationships we make with our patients, colleagues and the wider community.
We call this Delivering Compassionate Excellence and its focus is on our values of compassion, respect, learning, delivery, improvement and excellence.
These values put patients at the heart of what we do and underpin the quality healthcare we would like for ourselves or a member of our family. Watch how we set out to deliver compassionate excellence via the OUH YouTube channel .

Biobank Operations

• Provide day-to-day management of the HaemBio Biobank.
• Manage and oversee amendments to regulatory authorities.
• Ensure that Biobank operations are in accordance with SOPs and all regulatory and research governance requirements (including the Human Tissue Act). This includes quality control and maintenance of the Biobank’s documentation, regular audit of banking process, and investigations of deviations in practice, which should be reported to the Biobank Governance Committee as appropriate.
• Provide advice and support to other staff members with regard to Biobank and research governance and conduct.
• Maintain strong relationships and good communication with other key personnel in the Biobank.
• Manage and conduct regular audits, dealing with complex facts or situations requiring analysis, interpretation and comparison of options to ensure compliance with HTA requirements.
• Co-ordinate data collection and storage with Tissue Collection Centres and liaise with external database provider to ensure that the online database is fit for purpose.
• Communicate complex and sometimes sensitive information with relevant parties including external collaborators with matters relevant to the Biobank including outreach activity and monitoring visits of Tissue Collection Centres.
• Assist the Chief Investigator in ensuring that the Biobank operates with agreed budgets in conjunction with the Biobank Governance Committee, including maintaining spreadsheets of expenses, raising purchase orders, and ensuring payment of invoices.
• In conjunction with the Biobank Governance Committee and University Research Services ensure appropriate contracts are in place for the conduct of the work with external parties.
• Maintain knowledge of Biobank governance issues and an understanding of national and local policies.

Performance Management and Service Development

• Organise and attend the Governance Committee meetings.
• Organise regular update meetings with relevant stakeholders including Tissue Collection Centres and Researchers, undertaking qualitative assessment to ensure compliance with a range of targets.
• Maintain the Biobank website.
• Assist the Governance Committee members with the preparation of reports and manuscripts to share progress with funders, collaborators and wider public.
• With support from the Governance Committee, assist with the development and

implementation of operational and strategic policy for the Biobank.

• In consultation with the Governance Committee, take the lead in the development of

standard operational procedures (SOPs) for the Biobank, and assist in implementation of new amendments.

• Assist in gaining regulatory and ethical approval for future protocol amendments.
• Assist with recruitment, training and supervision of Biobank staff members as appropriate.

Personal Education, Training and Development

• Keep up-to-date with departmental Trust, NHS, MHRA policies of managing the Biobank to ensure timely effective implementation of changes.
• Attend relevant courses, meetings and conferences. Contribute to the development and improvement of the Biobank.

• Oversee and review protocol amendments, applications to REC, HTA and other organizations before they are submitted to the Sponsor/R&D.
• Providing day-to-day management, you will oversee and coordinate the administrative activities involved in HaemBio Biobank. It requires excellent communication, organisational and planning skills. You will be a member of the Biobank Governance Committee which will have oversight of the running of the Biobank.
• Maintain oversight of Biobank Master File ensuring that the studies are conducted in compliance with all Biobank SOPs and conducted to the standards outlined by the relevant British and EU laws, regulations and guidelines.
• You will be expected to liaise with our Tissue Collection Centres on a day-to-day basis and to organise Governance meetings to ensure compliance with quality measures and established standard operating protocols, in accordance with policies of the sponsors of the Biobank.
• Manage and conduct regular audits to ensure compliance with HTA requirements.
• You will work with local investigators at Tissue Collection Centres and report to Prof Paresh Vyas, who is the Chief investigator for the Biobank. You will be the central point of contact for researchers applying to the Biobank for access to patient samples and data.
• You will maintain systems and processes that ensure high standards are maintained and that the core purpose of the Biobank is met