Programme Officer

We are seeking to recruit a Programme Manager, for a fixed term of 11 months for our public sector client in D2. This is a maternity leave cover. The role will be hybrid with a minimum of 1 day in the office.

Key responsibilities:

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.

They will work with the management team within the National Office to develop effective policies, processes and procedures to support the work under the European Union Clinical Trials Regulation
They will foster strong working relationships with key stakeholders including the Department of Health, institutional / local RECs and the Health Products Regulatory Authority (HPRA) and European Medicines Agency (EMA) and ensure that the role is understood within the Irish health research framework and can add value to and work cohesively within the health research environment.
They will play a vital role in collaborating with other Programme Managers in the National Office to implement relevant policies, procedures and information resources to support the operations of an application, review and appeals process, with a strong focus on ensuring National Office staff are skilled and trained on the EU clinical trial application portal;
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;
Ensure appropriate training for staff on the Clinical Trials Information System (CTIS).
Assume a leadership role in developing and implementing standards, policies and procedures to underpin the system.
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.

Essential knowledge and experience

Competencies

This role profile reflects the grade/responsibilities appropriate to R&I V, Senior Researcher, Services V (Grade VIII) and maps approximately to a Civil Service role at Assistant Principal level.

An NFQ Level 9 Qualification (Master’s Degree) as a minimum
At least five years’ appropriate professional experience in academic, governmental, commercial or not-for-profit health and social care research setting
Strong understanding of health research governance, national and international regulatory and legislation, data protection and policy issues
Knowledge of the national health research system, and of the Irish academic and health services environment would be a distinct advantage
Knowledge and understanding of research ethics and experience of providing support to an ethics committee or similar committee would be a distinct advantage

Desirable requirements include:

Knowledge of the EU Regulations, including CTR would be desirable
Coordination of cross-organisational project teams
Analysis, critical thinking, problem solving and decision making

Teamwork and coordination with others are crucial elements of the role, in addition to an ability to work flexibly and in a frequently fast-paced environment.

**Please note that this is a contract role for 11 months**

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