Research Ethics and Data Governance Manager

Who are we?

We are Cambridge CARES, the University of Cambridge’s research centre in Singapore, established under the National Research Foundation (NRF) CREATE programme CAM.CREATE. Within Cambridge CARES, BloodCounts! is a collaborative research initiative bringing together the University of Cambridge, A*STAR, NTU, NUS, SingHealth, and many other partners in the Belgium, The Gambia, Ghana, India, the Netherlands and the UK (www.cares.cam.ac.uk/research/bloodcounts).

BloodCounts!-AI for Science (AI4S) focusses on elevating the value of the complete blood count (CBC*), the most common clinical test globally, by developing new AI methodologies. In particular, we have access to population scale raw flow cytometry data that is used to generate the summary CBC report used by millions of clinicians and healthcare workers on a daily basis. We have demonstrated that applying AI methods to this data allows for additional insights to be discovered, such as identifying markers for cancers, iron deficiency and pregnancy outcomes.

This NRF AI for Science project will develop multi-modal foundation models of the blood using not only flow cytometry data but also cell level imaging data. These will be developed using anonymised data from NUHS and SingHealth patients, with the aim of developing a population scale foundation model of blood that performs equitably for all genetic ancestries in Singapore. The models developed will be applied to clinical studies for Stroke and Lung Cancer, with the aim to identify new biomarkers that impact clinical treatment.

This project will integrate into the wider BloodCounts! consortium (www.bloodcounts.org), allowing for co-development of models and testing of hypotheses in European, African, South Asian and East Asian populations. Researchers globally will be able to access our models and insights through a secure platform, APIs and open sourced code and models that may be fine-tuned.

The BloodCounts!-AI4S Team is led by Profs. Michael Roberts and Carola-Bibiane Schönlieb (Department of Applied Mathematics and Theoretical Physics (DAMTP), University of Cambridge) and Prof. Lin Weisi (College of Computing & Data Science, Nanyang Technological University). They are supported by the following Principal Investigators: Dr. Nicholas Gleadall (University of Cambridge), Prof. Hui Ji (NUS), Dr Shir Ying Lee (NUHS), Prof. Mickey Koh (St. George’s Hospital, London; ACTRIS, Singapore), Dr Hwee Kuan Lee (A*STAR), Prof. Parashkev Nachev (University College London Hospitals), Prof. Willem H Ouwehand (University of Cambridge), Dr Suthesh Sivapalaratnam (Barts Health, London) and Prof. Iain Bee Huat Tan (SingHealth), alongside a large group of collaborators.

Who are we looking for?

The Research Ethics & Data Governance Manager will own the governance of the BloodCounts!-AI4S programme across the full lifecycle of data and AI use, ensuring that data, models and research activities are conducted ethically, legally, securely and in accordance with institutional, national and international requirements. Specifically, they will ensure that the BloodCounts!-AI4S research activities at CARES and its Singapore partner organisations comply with all relevant ethical, legal, and institutional requirements in Singapore, and will serve as a central contact point for researchers, administrators, and collaborators on matters related to research integrity and responsible conduct of research. They will also be responsible for ensuring that the project is compliant with all obligations and requirements of collaboration agreements, data access agreements and all other legal agreements. They will ensure good project governance through coordination with the Senior Management Team, Programme and Steering Committees, and Advisory Board, whilst ensuring all ethics and data governance documentation for the BloodCounts!-AI4S project is maintained.

The role holder will develop, coordinate and maintain the overarching research ethics applications and keep meticulous records of all amendments to the study protocol. They will be accountable to the responsible officer of the Senior Management Team on the preparation and review of documents for the relevant research ethics committees, submitting minor and substantial amendments, preparing progress reports and maintain renewals of ethics permissions. The role holder will be responsible for obtaining the appropriate permissions required when setting up the BloodCounts!-AI4S studies at NUHS and SingHealth. In all research activity whilst working closely with the BloodCounts!-AI4S team at CARES the postholder will also be the primary contact for ethics and data governance matters for Principal Investigators and Collaborators based at Singaporean organisations participating in the BloodCounts!-AI4S project. The role holder will provide ethics and data governance training and guidance to BloodCounts!-AI4S researchers and will keep in regular contact with the ethics and data governance manager in the UK.

The role spans the full lifecycle of data and AI use in the programme, and is organised around five governance pillars:

1. Ethics & regulatory approvals. IRB submissions, amendments and renewals; regulatory and institutional compliance; and ethics support to investigators.

2. Data access & governance. Data access requests and approvals; researcher onboarding, offboarding and periodic access reviews; and governance of data sharing, transfer and usage, with audit and compliance monitoring.

3. Data stewardship & lifecycle management. Dataset inventories and metadata; oversight of data provenance, lineage, retention and secondary use across institutions; and data quality and documentation standards.

4. AI & model governance. Oversight of AI/ML model development, validation, deployment, monitoring and documentation; transparency and reproducibility of model-development workflows; and maintenance of model and project governance records.

5. Programme governance & stakeholder management. Secretariat support for the data access and governance committees; governance reporting and risk management; and coordination across partner institutions.

* CBC, also known as FBC or Full Blood Count 

Requirements:

• Must have excellent written and verbal communication skills to articulate technical information about ethics and data governance to different stakeholder groups.
• A degree in a relevant discipline (e.g. life sciences, public health, law, or a related field), or equivalent professional experience in research governance. A PhD or postgraduate qualification in a clinical, biological or related field is desirable but not essential.
• Demonstrable experience in research ethics and data governance, including preparing, submitting and managing ethics/IRB applications, amendments and renewals.
• Working knowledge of the Singapore regulatory landscape for human biomedical research, including the Human Biomedical Research Act (HBRA), the Personal Data Protection Act (PDPA), and the relevant Institutional Review Boards.
• Understanding of data protection and data governance frameworks across more than one jurisdiction (Singapore PDPA and, ideally, UK GDPR / Data Protection Act 2018).
• Experience interpreting and ensuring compliance with legal agreements such as data access/sharing agreements, collaboration agreements and material transfer agreements.
• Familiarity with (or a clear aptitude to develop) governance processes for AI and machine-learning models, including oversight of model development, validation, deployment, monitoring and documentation.
• Excellent written and verbal communication skills, with the ability to articulate technical and regulatory information to different stakeholder groups.
• Strong organisational skills, with a proven ability to track and manage multiple deadlines, approvals and compliance obligations simultaneously.

Desirable criteria are:

• Experience of governance for healthcare, genomic or other sensitive data.
• Knowledge of responsible conduct of research frameworks and experience delivering training to researchers.
• Awareness of AI/ML methods in a healthcare or research context, sufficient to understand data flows and model-development pipelines.
• Familiarity with NRF/CREATE requirements, or comparable major-funder compliance frameworks.

Key Responsibilities:

Primary Coordinating Responsibilities (20%)

• Act as ethics and data governance representative of the study to collaborating organisations.
• Be a primary contact point for investigators, collaborators, internal teams and participants for ethics and data governance queries.
• Query resolution (e.g. Research Ethics Committees, regulatory bodies, R&D departments of collaborating sites and studies, research study coordinators).
• Support the coordination of multidisciplinary and multi-institutional BloodCounts!-AI4S research projects involving both Singaporean and international partners.
• Work with the Lead Senior Scientific Project Manager, Lead Machine Learning Researcher and Lead Research Software Engineer of the BloodCounts!-AI4S team at CARES for monitoring data delivery and use of data by researchers and ensure regulatory compliance.
• Coordinate and support research project-related activities and events as required.

Research Ethics Responsibilities (20%)

• Prepare, submit and maintain applications for ethics and regulatory approvals and amendments for the BloodCounts!-AI4S research studies.
• Assist in drafting research proposals and ethics-related sections of grant applications, ensuring alignment with NRF and institutional frameworks.
• Review requests for data access by researchers and keep records of individuals who have been granted access to data.
• Prepare and maintain record of Standard Operating Procedures for the use and analysis of data and ensure adherence by researchers to study protocols.
• Produce reports by gathering and analysing data as required by stakeholders.

Organisational (20%)

• Keep up to date with research management issues.
• Ensure meticulous and accurate storage of records of electronic data use for audit and review.
• Ensure that researchers can only use data to which they have ethical approval, for the time period that they have such approval.
• Ensure that all research performed within the project complies with the study protocol and ethical permissions and relevant NRF and institutional policies.
• Serve as the principal liaison between CARES and local Institutional Review Boards (IRBs), Data Access Committees, and regulatory authorities.
• Liaise with members of the multidisciplinary BloodCounts!-AI4S team at regular intervals.
• Oversee the maintenance of site master files and research study files up to date.
• Maintain minutes of regular ethics and data governance meetings and follow-up on actions agreed during such meetings.
• Track progress of applications submitted to research ethics and other relevant committees, approvals notifications, site registration, etc.

Coordination of research studies (20%)

• Communicate with Principal Investigators and Collaborators about approved study protocols.
• Prepare relevant content about ethics and data governance to maintain public transparency about the processes and procedures used by the BloodCounts!-AI4S team to maintain data security.
• Facilitate communication among investigators, research support staff, and collaborators to ensure ethical and regulatory requirements are fully integrated into project workflows.
• Contribute to the development and implementation of institutional policies on research ethics, data governance, and research integrity.
• Identify ethics and data governance items that need to be considered by the senior project management team.
• Maintain records of the research databases used for the BloodCounts!-AI4S study at CARES and partner organisations in Singapore.
• Participate in CARES and CREATE governance committees and working groups focused on ethics, compliance, and research integrity.
• Monitor evolving regulations and best practices in Singapore and internationally, advising the BloodCounts!-AI4S project management team on implications for BloodCounts!’ research operations.

Educational and Training (10%)

• Generate reports and present on ethics and data governance areas to the wider BloodCounts!-AI4S research community in Singapore.
• Attend local CARES and national meetings on ethics and data governance where applicable and feedback to the Senior Management Team of the BloodCounts!-AI4S project.

Public Engagement (10%)

• Assist with building and improving patient and public involvement and engagement.
• Undertake publicity activities linked to the ethics and data governance aspects of the research project, including by maintaining and updating relevant parts of the BloodCounts! website at CARES.
• Organise BloodCounts!-AI4S events such as patient and public events, workshops, and training sessions for researchers, as required.
• Any other responsibilities commensurate with the grade and position.

Please note that this post is mainly based in the CREATE Tower at NUS University Town, Singapore.

When is the position available and for how long?

The position is available for an immediate start and is offered on a fixed-term contract of two years in the first instance, with the possibility of extension.