HRB Grade VIII Job Family (consisting of R&I V / Senior Researcher / Service V grade)

 

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 – healthy people through excellent research and applied knowledge. The Health Research Board’s (HRB) mission is to improve people’s health and enhance healthcare delivery.  The Health Research Board’s (HRB) 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/strategy-2025/).

The National Office for Research Ethics Committees is a business unit within the Health Research Board (HRB), with a statutory function in the regulation of health research (www.nrecoffice.ie) and works under the auspices of the Department of Health. The primary function of the National Office is to support a robust and transparent system of National Research Ethics Committees (NRECs), which provide competent and timely ethics assessment of regulated research studies to ensure the safety, dignity and wellbeing of research participants.

The NRECs are mandated under legislation, or by ministerial instruction, to return ethics decisions that are respected nationally (‘single national ethics opinion’) and specifically to meet Ireland’s requirements under the Medical Devices Regulation (MDR: EU No 2017/745) [1], the In Vitro Diagnostic Medical Devices Regulation (IVDR: EU No 2017/746) [2] and Clinical Trial Regulations (CTR: EU No 536/2014).[3]

Furthermore, the implementation of the Clinical Trial Information System (CTIS), the pan-European online portal also came into effect in January 2022, introducing a new and complex system for applications for regulated clinical trials to be submitted under the Clinical Trials Regulations (CTR).

The Committees we support and areas of research that fall under the remit of these committees are:

  • National Research Ethics Committee for Medical Devices (NREC-MD) for clinical investigations of medical devices and performance studies of in vitro diagnostic medical devices,
  • National Research Ethics Committee for Clinical Trials (NREC-CT; A, B, C, D) for Medicinal Products for Human Use,

Currently, the National Office supports 100 members across these 5 committees. Following a restructuring in January 2024, there are now four NRECs for clinical trials for medicinal products (NREC-CT A, B, C, D) and constituted in total with just over 70 members. In 2025, the NREC-CTs delivered 111 opinions on new clinical trial study applications and 311 opinions on substantial modification applications, over the course of 49 meetings.

National Office receives applications for ethics approval on behalf of the NRECs and supports the Committees’ independent ethics review processes. Sponsors of clinical trials conducted under the Clinical Trials Regulations, must submit ethics applications for assessment, through the pan-European online portal Clinical Trial Information System (CTIS), which the National Office interfaces with. NRECs adhere to international best practice and the highest standards in research ethics review to protect the safety, dignity and well-being of research participants

The mission and vision for the National Office team is to ensure the national research ethics system is sustainable, agile and has capacity within a fast-evolving regulatory research landscape in Ireland and across Europe. Core to this mission is to ensure the National Office represents Ireland and its ability to meet the regulatory requirements under the European Union (EU) Regulations, in line with other EU member states.

 

Full time Programme Manager for NREC-CT

The HRB is now seeking to recruit a permanent full time Programme Manager for the National Office to support the NREC-CTs, the clinical trial application portfolio and the additional key responsibilities to engage and participate in EU expert groups and initiatives that are now core to the work of the National Office, for the implementation of the CTR and preparedness for the future implementation of the European Biotech Act.

This provides an opportunity for a suitably qualified candidate with senior management, strategic and leadership skills to oversee the management and operations of two of NREC-CTs and support the expansion of EU level work, representing national interests and perspectives on associated expert working groups initiatives.

The Programme Manager, with the assistance of their team, will provide strategic and operational support to the Head of Office, the Chairs, Deputy Chairs and other Committee members to enable the NREC-CTs to perform their functions effectively and efficiently.  The Programme Manager will support the Head of Office in the delivery of the National Office’s strategic priorities under the framework of the HRB’s next five-year cycle.

The Programme Manager will work closely with their fellow Clinical Trials Programme Manager to ensure consistency of operations and strategic alignment for all work related to the clinical trials portfolio.

 

Key responsibilities of the post of Programme Manager (NREC – CT)

This post offers an exciting opportunity for a suitably qualified candidate to join and assist with managing a vibrant team of dynamic and dedicated high-performing professionals whose core values of integrity, knowledge, collegiality and transparency drive their work of delivering an agile and trusted office in national public service. The National Office teams comprise of Programme Managers, Programme Officers, Project Officers, a Project Administrator and Administrative Assistant.

  • The Programme Manager, with the assistance of their team, will provide strategic and operational support to the Head of Office, the Chairs, Deputy-Chairs and all members of the NREC-CT to enable the NRECs to perform their functions effectively and efficiently.
  • They will work with the Head of Office and other Programme Managers to ensure appropriate constitution of membership of NRECs in line with national legislation, and support the NRECs to ensure that national decisions on the ethics underpinning Irish health research are informed by the diversity of skills, experience, interests and backgrounds reflective of contemporary Irish society.
  • They will work with the management team within the National Office to develop robust policies and procedures to support the NREC-CT and their work under the European Union Clinical Trials Regulation (EU CTR No 536/2014) and preparedness for future legislative amendments under the Biotech Act as required.
  • They will foster strong working relationships with key stakeholders including the Department of Health, institutional / local RECs and the Health Products Regulatory Authority (HPRA), working to shape and influence matters as it may pertain to the delivery of the national research ethics system in Ireland.
  • They will interact closely with applicant sponsors and the academic and healthcare research community and provide support and guidance in relation to the application submission and ethics assessment process, including providing expert knowledge in the requirements of the CTR.
  • They will support the Head of Office on strategy development and implementation and support collaborative work with the Department of Health to shape national legislation to ensure effective implementation of EU Regulations (CTR and Biotech Act) at a national level.
  • They will ensure the National Office is actively represented at an EU level, including participation in MedEthicsEU, Accelerating Clinical Trials in the EU (ACT EU) and EU initiatives and associated expert groups as required.
  • They will play a vital role in collaborating with other Programme Managers and wider team in the National Office to ensure operational excellence to support robust application management and ethics review, and implement operational changes as required, remaining agile and responsive to fluctuations in application volume to ensure an agile and efficient NREC system.
  • They will lead a strong team and ensure they are skilled to manage the requirements of the EU clinical trial application portal – the Clinical Trials Information System (CTIS) and support the NREC-CTs to deliver on their remit
  • They will assist the Head of Office and Finance unit of the HRB with all financial aspects of the National Office including management of fee income and administration of payments and expenses, and public consultation processes on application fees.

 

Duties will include (but are not limited to) the following areas of activity:

Operations of the National Office for Research Ethics Committees

  • Work with the Head of Office to ensure the National Office has adequate resources and skill sets to enable it to support the committee members and have the requisite competencies to conduct its work under the legislative frameworks;
  • Impart a culture of clear goals and responsibilities within the National Office and reporting staff;
  • Support the delivery of the National Offices’ strategy objectives by supporting the development and implementation of the annual service plan for the National Office and manage the day-to-day activities of the clinical trials team;
  • Manage the Performance Management Development Plans (PMDS) and for staff under their supervision and work with Human Resources in the recruitment and training of additional staff as necessary;
  • Promote and support highest standards of professionalism and integrity within the team and the NRECs, and in dealing with external stakeholders and applicants;
  • Oversee the management of ethics applications and national ethics decisions through the Clinical Trials Information System (CTIS), and liaise with the National Competent Authority, the HPRA to ensure EU regulatory timelines are met;
  • Support the implementation of the necessary IT systems to ensure the ethics application portfolio is managed efficiently.
  • Oversee and support the delivery of critical projects that underpin the operational and strategic objectives of the National Office; development procedures for pre-application submission advice to Sponsors, ethics guidance for emerging areas of regulated research;
  • The PM interacts closely with the academic and healthcare research community and is required to have a strong technical/scientific understanding of these environments, including an understanding of clinical trials, methodologies and associated scientific knowledge.

 

Strategic and operation support for National Research Ethics Committees for clinical trials (NREC-CTs)

  • Assume a leadership role in continuous development and implementation of standards, policies and procedures to underpin the NREC system. In this regard, they will acquire expertise in best practice in research ethics review, and national and EU laws, as they relate to the remit of the NREC-CTs;
  • Demonstrate leadership in adapting operations to changing requirements, developing and implementing responsive plans to manage fluctuations in application volume while maintaining high standards of efficiency and governance;
  • Develop expertise and provide guidance on ethical, technical and legislative matters to NREC-CTs, applicant sponsors and wide stakeholder community as they may pertain to research conducted under the CTR;
  • Oversee the preparation of NREC-CT meeting agenda and any other relevant documentation for Committee meetings, in consultation with the NREC Chairpersons/deputy Chairpersons;
  • Manage NREC-CT meetings, have responsibility for accurate minute-taking and oversee all actions arising from the minutes through correspondence with relevant committee members, applicants and other stakeholders with responsibility that national ethics opinions are delivered within timelines, through CTIS and in coordination with the HPRA;
  • Provider direct supervision to the Programme Officer and Project Officers regarding all aspects of the management of tasks that arise under CTIS and ensure all responses, considerations and communications through CTIS are conducted within legislative timelines to deliver a national ethics opinion for Ireland;
  • Support the Head of Office an annual report and periodic metrics reports on NREC activities for publication on the National Office website;
  • Ensure guidance documents for the Irish health research community and Sponsors on all areas of research ethics are developed and in line with best national and international practice, and in accordance with legislation as application;
  • Represent the National Office for Research Ethics Committees in relevant European initiatives, and liaise with other national and international agencies on implementation of the CTR;
  • In conjunction with the Head of Office and Chairpersons/deputy Chairpersons, identify and coordinate the provision of relevant training and continuous professional development (CPD) activities for Committee members;
  • Support and operationalise Ireland’s participation in key EU initiatives such as FAST-EU, the COMBINE Programme and EU4Health Joint Action programmes – in collaboration with the National Office Programme Managers, the NREC-CTs and NREC-MD and HPRA as required.

Managing policies and governance

  • Work with the Head of Office and other Programme Managers within the National Office to update, develop and implement policies and standard operational processes to govern the activities of the National Office and NRECs, in line with international best practice and in accordance with EU and Irish legislation;
  • Support the procurement needs for the National Office, work with the HRB procurement team to develop Procurement Frameworks where appropriate, including contributing to the implementation of any further procured products such as application management system;
  • Provide advice on ethics applications, Committee processes, and any other issues that might arise in the context of the NRECs in the performance of their statutory role.

Stakeholder engagement

  • Ensure a functioning central contact point and helpdesk function to respond to queries from health researchers prior to submission of applications and specifically in relation to the CTR and CTIS;
  • Develop ongoing engagement and communication with key stakeholders Government Departments, Institutional/local Research Ethics Committees, European Medicine Agency, research performing organisations, Health Service Executive, Data Protection Commission, other bodies and regulators;
  • Identify and organise, in conjunction with the Head of Office, relevant outreach activities to raise awareness and understanding of ethical requirements, as well as of the role of the NREC among the health research community;
  • Build visibility of the National Office on a local and international stage by securing representation on key Irish and EU fora to represent Ireland’s interests and shape the research agenda as it relates to ethics and integrity.

Other duties may be assigned depending on need. This is a team-based role, and teamwork and coordination with others are crucial elements of the job description.

Essential knowledge and experience

Formal requirements include:

  • A NFQ Level 9 Qualification (Masters Degree/Postgraduate Diploma) is required as a minimum, a NFQ level 10 (Doctorate) is desirable in a relevant field (biomedical sciences, the healthcare professions, law, and ethics)
  • At least five years’ appropriate professional experience in academic, health research bodies, governmental, commercial or not-for-profit health and social care research setting.
  • Strong working knowledge of clinical trials research, methodology and associated scientific knowledge, health research ethics and governance, national and European health research regulations and legislation, including the CTR.
  • 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 a distinct advantage
  • Knowledge of the national health research system, and of the Irish academic and health services environment would be a distinct advantage
  • Working knowledge research ethics and experience of managing an ethics committee or similar committee would be a distinct advantage

Additional desirable experience will include the following:

  • Knowledge of the Clinical Trials Information System
  • Ability to manage and coordinate interdependent and cross-functional teams
  • Ability to lead, be a strategic thinker and deliver operational excellence
  • Ability to deliver with quality under strict legislative timelines
  • Strong interpersonal and communication skills.
  • Analysis, critical thinking, problem solving and decision making
  • Ability to communicate, network and influence people and expert groups
  • Ability to manage competing deadlines and priorities across multiple work areas
  • A high degree of motivation and resilience
  • A high level of professional integrity, ethics and strong public service values and accountability

 

Competencies

Competencies incorporated into this role profile reflect the competency framework issued in conjunction with the Civil Service Competency Framework which has been adopted by the HRB.  A comprehensive list of expected competencies can be found at Assistant Principal Competency Framework.

 

Reporting relationship

The Programme Manager, NREC-CT will report to the Head of the National Office for Research Ethics Committees.

 

Salary scale

Salary Range for Programme Manager, NREC-CT (Grade VIII)                                         € 83,081 – €100,205

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.

Closing date for applications is 12.00 Noon on 25 May 2026

NOTE: Interviews for this position are expected to take place in our offices on 08 June 2026.

If you require further information, please contact Karen O’Donnell, HR Officer at recruitment@hrb.ie or refer to the recruitment page on the HRB website at http://www.hrb.ie/about/recruitment/  for full details on this campaign.

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.

Please Note:

To be eligible to apply for this competition, candidates must be nationals of a European Economic Area (EEA) Member State or otherwise have a current and valid legal entitlement to work in Ireland.

Candidates who do not meet this requirement will be deemed ineligible.