Information Governance Manager

14150BR

School of Medicine

Managerial, Professional and Specialist Staff – MPSS

Advert

Information Governance Manager
Centre for Trials Research
College of Biomedical & Life Sciences

The Centre for Trials Research (CTR) at Cardiff University is the largest group of academic clinical trials staff in Wales, and has earned full UK Clinical Research Collaboration (UKCRC) registered status. The Centre tackles the big diseases and health concerns of our time, including growing resistance to antibiotics, early cancer diagnosis and how to eliminate health inequalities. It achieves this by forming partnerships with researchers and building lasting relationships with the public, whose participation is essential for the success of studies.

You will deliver specialist information governance, data protection and audit work to the Centre, providing advice, guidance and support and leading specialist areas with a focus on data sharing processes and activities, evolution of data governance activities and providing specialist advice on legal and regulatory compliance in the areas of quality assurance, data management, and information security.  You will take responsibility for individual projects, using your specialist knowledge to solve issues independently as they arise.  You will work with trial teams to ensure that the Centre’s clinical trials and studies are undertaken in a regulatory compliant way and are prepared for regular audits and inspections.  You will oversee and ensure delivery of the Centre’s internal audit programme by the Centre internal auditors.

Candidates should hold a degree/NVQ4 or equivalent professional membership or have equivalent experience of working in Quality Assurance, Data protection/Information Governance and Clinical Trials, and proven experience in developing new systems and processes.  Candidates should have the ability to communicate conceptually detailed and complex information effectively and professionally with a wide range of people and be able to solve expansive problems using initiative and creativity.  Knowledge of trusted research environments, data safe havens and modern integration strategies would be advantageous.

For informal queries, please contact Claire Johnson, Head of QA & RA email: [email protected]

This post can be full or part-time (minimum of 25 hours per week), available from 11th July 2022 and is open ended.

Salary: £34,304 – £40,927 per annum, pro-rata if worked part-time (Grade 6)

Date advert posted: Friday, 20 May 2022

Closing Date: Monday, 6 June 2022

Cardiff University is committed to supporting and promoting equality and diversity and to creating an inclusive working environment. We believe this can be achieved through attracting, developing, and retaining a diverse range of staff from many different backgrounds. We therefore welcome applicants from all sections of the community regardless of sex, ethnicity, disability, sexual orientation, trans identity, relationship status, religion or belief, caring responsibilities, or age.  In supporting our employees to achieve a balance between their work and their personal lives, we will also consider proposals for flexible working or job share arrangements.

Job Description

Job Purpose

Deliver for the Centre high quality audit, information governance, data protection work as it pertains to clinical trials data integration. Providing QA & RA advice, guidance and support, and leading specialist areas with particular focus on:
•    Working with a range of data controllers across the academic, health and social-care, education and local authority domains to provide specialist support to optimise the Centre’s data sharing processes and activities and to lead on the development of appropriate data sharing agreements between data controllers and processors to enable data sharing
•    Working with our partners to ensure the alignment with existing information governance requirements and the evolution of that governance for Centre specific activities
•    Providing specialist advice on legal and regulatory compliance in the areas of quality assurance, data management, information security, with particular reference to GDPR and other data protection laws and ethical frameworks and how these relate to our data providers and other external stakeholders.

Duties and Responsibilities

Key Duties
•    Provide professional advice and guidance on quality assurance, audit, data protection and information governance processes and procedures to internal and external customers advising on the impact of clinical trials data protection and information governance on the Centre’s strategic developments and plans
•    Take responsibility for resolving issues independently within quality assurance, audit, data protection and information governance where they fall within set role objectives, using judgement and creativity to suggest the most appropriate course of action and ensuring complex and conceptual issues and solutions are understood by the audience
•    Plan and deliver projects relating to quality assurance, audit and information governance that have a Centre-wide impact. Create and facilitate project teams as needed, planning, organising, setting tasks, delegating work, monitoring progress and solving problems independently as they arise.
•    Investigate and analysis specific issues within Data Protection and Information Governance, creating recommendation reports, supported by advances within clinical trials and data protection.
•    Ensure that the provision of data protection and information governance is delivered to the Centre, proactively changing the delivery according to external stakeholder’s requirements, contributing to the development of the Centre’s standards within the field of information governance.
•    Establish relationships with key contacts to ensure role objectives are met, developing appropriate communication links with the University’s Schools/Directorates and outside bodies as required
•    Create specific working groups from colleagues across the Centre and wider University to achieve Centre objectives
•    Develop and deliver training within quality assurance, audit and information governance as it pertains to clinical trials data integration
•    Instruct and guide other employees across the institution  as it pertains to Centre for Trials Research data integration.
•    Undertake a variety of quality assurance activities and administrative duties to support the department
•    Ensure that work is undertaken and documented in a regulatory compliant way and be prepared for regular audits and inspections, as well as contributing to the development of the Quality Management system for the area of audit, data protection and information governance

***Continued in additional information***

Person Specification

Essential Criteria

Qualifications and Education

1.    Degree/NVQ4 or equivalent experience in Quality Assurance, Data Protection/Information Governance and Clinical Trials.

Knowledge, Skills and Experience

2.    Substantial experience of working within Quality Assurance, Audit, Data Protection/Information Governance and
Clinical Trials Regulations
3.    Able to demonstrate expert professional knowledge within Quality Assurance, Audit, Data Protection, Information Governance and Clinical Trials Regulations
4.    Proven experience in developing new processes and procedures

Customer Service, Communication and Team Working

5.    Able to influence decisions within specialist discipline that have a strategic impact
6.    Evidence of ability to explore customers’ needs, adapt the service, and set customer expectations
7.    Proven ability to develop networks in order to contribute to long term developments

Planning, Analysis and Problem solving

8.    Evidence of ability to research and solve expansive problems using initiative and creativity; identify and propose both practical and innovative solution
9.    Evidence of demonstrable knowledge of key advances within specialist discipline
10.  Evidence of ability to undertake and deliver specific projects and supervise short term project teams

Desirable Criteria

1.    Experience of working in a Higher Education environment
2.    Knowledge of Trusted Research Environments, Data Safe Havens, and modern  data integration strategies
3.    Experience in hosting, managing and responding to external audits or regulatory inspections
4.    Fluency in Welsh, written and oral

Additional Information

***Continued from Job Description***

General Duties
•    Ensure that an understanding of the importance of confidentiality is applied when undertaking all duties
•    Abide by University policies on Health and Safety and Equality and Diversity
•    Perform other duties occasionally which are not included above, but which will be consistent with the role

IMPORTANT: Evidencing Criteria

It is School of Medicine's policy to use the person specification as a key tool for short-listing. Candidates should evidence that they meet ALL of the essential criteria as well as, where relevant, the desirable. As part of the application process you will be asked to provide this evidence via a supporting statement.

Please ensure when submitting this document / attaching it to your application profile you name it with the vacancy reference number, in this instance for this post, 14150BR

If candidates do not provide written evidence of meeting all of the essential criteria then their application will not be progressed. The School of Medicine welcome the submission of CVs to accompany evidence of the job-based criteria.

Job Category

Admin / Clerical, Management & Executive