Key Requirements

1. PhD. or Masters degree in Biostatistics.
2. A minimum of 6 years relevant experience in a clinical research
3. Oncology background/ experience an advantage but not a
4. Familiarity with complex statistical methods and regulatory requirements applicable to Phase I-IV clinical trials.
5. Good working knowledge of statistical software and programming languages such as SAS and other Microsoft applications for the design and analysis of clinical trials.
6. Excellent written and oral communication skills with good interpersonal
7. Demonstrate problem solving ability, critical thinking, flexibility, and ability to manage multiple projects with varying priorities.
   

   Main Function(s)

   • Collaborate with Chief Investigators and academic institutions across Ireland in the development of investigator-led clinical trials, and with international collaborative groups as Group Statistician for Cancer Trials Ireland.
   • Accountable for selecting statistical methods for data analysis, authoring the corresponding sections of clinical trial protocols and statistical analysis plans. Accountable for conducting trial analyses and producing final statistical reports.
   • Contribute to strategic planning in Cancer Trials
   • Provide oversight of third party providers and statistical support for national cancer clinical trial group/unit investigators in the development and conduct of clinical trials.
   • Key member of study steering and oversight committees such as Safety Monitoring, Medical Oversight, Phase IB committees and Trial Steering Committee if applicable.

   Primary Responsibilities

   • Provide statistical support to study design and protocol development/ amendments, including defining analysis populations, endpoint selection, statistical model specification and sample size
   • Provide statistical input to CRF and clinical database design, also data management processes up to Dry Run and Database Lock.
   • Oversee the randomisation and blinding process on applicable
   • Develop statistical analysis
   • Perform statistical analyses, including appropriate summaries of data and tests of
   • Write statistical reports or provide statistical contribution to integrated clinical
   • Produce and present reports required for regular study steering and oversight
   • Support Clinical Operations team during the study life cycle in the determination of the evaluability of study subjects, risk assessment and management, and major protocol deviation
   • Contribute to publications in leading international high impact medical journals and input into meeting and symposia abstracts, posters and presentations.
   • Perform or oversee meta-analyses on pooled data from multiple
   • Maintain the statistical components of Trial Master
   • Ensure statistical methods and procedures adhere to regulatory guidelines and company
   • Responsible for the quality and timely completion of all statistical tasks and
   • Oversee the statistical programmers ensuring robust quality control processes in
   • Participate and represent Cancer Trials Ireland in audits and regulatory
   • Keep abreast of new statistical concepts and techniques and changes in regulatory
   • Lead development and update of internal statistical guidelines and SOPs and contribute to development and update of relevant internal guidelines and SOPs.
   • Provide relevant statistical training to

Location

Cancer Trials Ireland

To Apply and for more Infomration Contact:

Patricia Dignam, HR Manager: patricia.dignam@cancertrials.ie

This is a permanent full time post.

HRB Grade VIII Job Family (consisting of R&I V, Services V & Senior Researcher  grades).

You can download the job description here (in PDF)

Background

The Health Research Board (HRB) is a statutory agency under the aegis of the Department of Health. As the lead agency in Ireland responsible for supporting and funding health research, generating health information and promoting the use of evidence in policy and practice, we are motivated and inspired by our vision – for better health through excellent research, data and evidence. The HRB’s mission is to support research that improves people’s health, promotes evidence-informed care and creates solutions to societal challenges.  An overview of the HRB’s objectives and activities may be found in The HRB Strategy 2021-2025, Health research – making an impact, (https://www.hrb.ie/about/strategy-2025/).

The Health Research Regulations 2018, made by the Minister for Health under section 36 (2) of the Data Protection Act, provide for the safeguarding of personal data for health and social care research in Ireland. Under the Regulations, in exceptional cases where explicit consent cannot be obtained the Health Research Consent Declaration Committee (HRCDC) may make a consent declaration where the public interest in conducting the research significantly outweighs public interest in the requirement for consent.

The Health Research Consent Declaration Committee (HRCDC) was established in March 2019 and has made over 80 consent declarations for research studies that it considered were in accordance with the Regulations. The HRCDC is supported by a Secretariat in the HRB.

The HRB is now seeking to recruit a permanent, full-time Programme Manager to lead the Secretariat.

The Programme Manager, with the assistance of their team, will provide strategic and operational support to the Chair and members of the HRCDC and they will work with the research community and relevant stakeholders to ensure that the role of the Committee is understood within the Irish health research ecosystem.

They will provide high level advice on ethical and data protection issues relating to the granting of declarations and play a vital role in developing and implementing relevant policies, procedures and information resources to support the HRCDC.

Key responsibilities of the post of the Program Manager (Health Research Consent Declaration Committee)

Duties will include, but are not limited to:

Delivery of a professional and responsive secretariat support function

• Lead the Secretariat team to ensure it performs its role to a high quality and standard and is cohesive and collaborative in its function
• Provide technical support, or oversee the commissioning of same, to ensure that the HRCDC has the information and infrastructure it needs to make decisions
• Support the effective preparation and organisation of Committee meetings
• Ensure that appropriate processes, practices and systems, including ICT systems, are in place and maintained to support the work of the HRCDC
• Attend Committee meetings, ensure accurate minute-taking to accurately convey Committee decisions and other feedback
• Ensure the timely receipt and review of annual reviews for HRCDC consent declarations
• Work with the Chair to prioritise and deliver training for HRCDC members
• Systematically collect, collate and publish metrics on HRCDC applications and declarations
• Secure and account for resources to deliver HRCDC secretariat activities.

Engagement with the Department of Health in respect of governance and oversight of the HRCDC

• Engage with the DoH to ensure that the HRCDC remains appropriately constituted and to discuss any amendments to the regulations
• Prepare, in conjunction with the Chair, an annual report for the Minister for Health
• In the event that an Appeals Panel is appointed by the Minister to hear appeals from decisions of the Committee, engage as required
• Engage with the DOH regarding emerging legislative changes as they may impact the work of the Secretariat and HRCDC.

Communication and Outreach with the research community and other stakeholders

• Proactively engage with the health research community to promote the work of the HRCDC and an understanding of relevant developments
• Act as the lead point of contact for queries from health researchers prior to submission of applications
• Develop informational reports, statistics and presentations to support communication of the HRCDCs role and impact and maintain an effective website
• Participate in national and international fora and networks to identify examples of best practice, innovative approaches and new opportunities to ensure that the HRCDC practices remain appropriate, credible and robust
• Engage with the National Office for Research Ethics Committees, the HSE, the DOH, DPC and other national stakeholders, including international for a such as the EDPB as required to ensure the business of the HRCDC and Secretariat is prepared to adapt to emerging regulatory and legislative changes
• Present at key external meetings to foster understanding and visibility of the role of the Secretariat and the HRCDC
• Organise webinars and other information events to support the work of the Secretariat, including education and outreach.

Essential knowledge and experience

The Programme Manager (HRCDC), with the assistance of their team, will provide strategic and operational support to the Chair and members of the HRCDC and they will work with the research community and relevant stakeholders to ensure that the role of the Committee is understood within the Irish health research ecosystem. They will provide high level advice on ethical and data protection issues relating to the granting of declarations and play a vital role in developing and implementing relevant policies, procedures and information resources to support the HRCDC.

Formal requirements include

The successful candidate will ideally be PhD qualified but must, at a minimum, have a NFQ Level 9 qualification (Masters / Post Graduate Diploma) in a relevant field with at least three years’ relevant experience post-degree.
NOTE: A relevant field includes the biomedical sciences, the healthcare professions.

The successful candidate must also have:

• At least five years appropriate professional experience in academic, governmental, commercial or not-for-profit settings
• At least two years strong understanding of health research governance, regulatory environment, data protection legislative and policy issues law, and bioethics.
• Demonstrated experience of managing people and committees or large-scale projects

Desirable requirements include

• High degree of computer literacy, including knowledge and experience of using Microsoft Word, Excel, Outlook.  Experience of databases and on-line application systems would be desirable
• Knowledge of the national health research system, and of the Irish academic and health services environment

Competencies

This role profile reflects the grade/responsibilities appropriate to Services V / R&I V / Senior Researcher in the HRB and maps approximately to a Civil Service role at Assistant Principal  level. Competencies incorporated into the role profile reflect the competency framework issued in conjunction with the Civil Service PMDS for 2013 which has been adapted by the HRB.

Competencies include:

• Excellent analysis and decision-making skills
• Demonstrated management and delivery of results
• An ability to effectively communicate the vision and values of the HRCDC
• Ability to engage effectively with HRCDC Chair and members in delivering on HRCDC work
• Ability to network and influence people
• A high level of confidentiality, discretion and professional integrity and ability to communicate with these value.
• Ability to communicate in a fluent, logical, clear and convincing manner verbally and in writing.
• Ability to work under pressure and meet deadlines.

Core Competencies for the Programme Manager (HRCDC) are listed in Appendix A.

Reporting relationship

As the secretariat supporting the HRCDC interacts closely on regulatory matters with the National Office supporting National Research Ethics Committees (also hosted by the HRB), the Programme Manager of the HRCDC secretariat will report to the Head of the Office for National Research Ethics Committees.

Salary scale

Salary Range for Programme Manager – HRCDC (Grade VIII)  € 73,941 – € 89,181

Note: this post is a permanent, full-time position

Appointment will be made in accordance with the Department of Health guidelines. New entrants to the public service will be appointed at the first point of the scale.

How to apply

Please submit a cover letter and curriculum vitae by email to recruitment@hrb.ie.  You must include the name of the post that you are applying for in the email subject line.

NOTE: Interviews for this post are expected to take place between 12 and 16 December 2022.

If you require further information, please contact Karen O’Donnell, HR Officer at recruitment@hrb.ie.

The Health Research Board is an equal opportunities employer and welcomes applications from all sections of the community. We do not discriminate based on gender, age, race, religion, marital status, sexual orientation, disability, membership of the Travelling community or family status. If you have a disability and require accommodations to be made during the recruitment process, please contact HR in advance and we would be happy to assist.

Appendix A: Core competencies – Programme Manager (Health Research Consent Declaration Committee)

Leadership

• Actively contributes to the development of the strategies and policies of the Department/ Organisation
• Brings a focus and drive to building and sustaining high levels of performance, addressing any performance issues as they arise
• Leads and maximises the contribution of the team as a whole
• Considers the effectiveness of outcomes in terms wider than own immediate area
• Clearly defines objectives/ goals & delegates effectively, encouraging ownership and responsibility for tasks
• Develops capability of others through feedback, coaching & creating opportunities for skills development
• Identifies and takes opportunities to exploit new and innovative service delivery channels

Judgement, analysis and decision making

• Research’s issues thoroughly, consulting appropriately to gather all information needed on an issue
• Understands complex issues quickly, accurately absorbing and evaluating data (including numerical data)
• Integrates diverse strands of information, identifying inter-relationships and linkages
• Uses judgement to make clear, timely and well-grounded decisions on important issues
• Considers the wider implications, agendas and sensitivities within decisions and the impact on a range of stakeholders
• Takes a firm position on issues s/he considers important

Management and delivery of results

• Takes responsibility for challenging tasks and delivers on time and to a high standard
• Plans and prioritises work in terms of importance, timescales and other resource constraints, re-prioritising in light of changing circumstances
• Ensures quality and efficient customer service is central to the work of the division
• Looks critically at issues to see how things can be done better
• Is open to new ideas initiatives and creative solutions to problems
• Ensures controls and performance measures are in place to deliver efficient and high value services
• Effectively manages multiple projects

Interpersonal and communication skills

• Presents information in a confident, logical and convincing manner, verbally and in writing
• Encourages open and constructive discussions around work issues
• Promotes teamwork within the section, but also works effectively on projects across Departments/ Sectors
• Maintains poise and control when working to influence others
• Instils a strong focus on Customer Service in his/her area
• Develops and maintains a network of contacts to facilitate problem solving or information sharing
• Engages effectively with a range of stakeholders, including members of the public, Public Service Colleagues and the political system

Drive and commitment to public service values

• Is self-motivated and shows a desire to continuously perform at a high level
• Is personally honest and trustworthy and can be relied upon
• Ensures the citizen is at the heart of all services provided
• Through leading by example, fosters the highest standards of ethics and integrity

Specialist knowledge, expertise and self-development

• Has a clear understanding of the roles, objectives and targets of self and team and how they fit into the work of the unit and organisation and effectively communicates this to others.
• Has high levels of expertise and broad Public Sector knowledge relevant to his/her area of work and is sensitive to wider political and organisational priorities
• Is considered an expert by stakeholders in own field/area
• Is focused on self-development, seeking feedback and opportunities for growth to help carry out the specific requirements of the role

Closing Date

 12.00 Noon on 30 November 2022.