On behalf of our Research Client based in Dublin, we are hiring a
Programme Manager
to join their team on a 5 month contract.
The Programme Manager will work closely with the other Programme Manager to ensure consistency of operations and strategic alignment for all work related to the clinical trials portfolio.
Key responsibilities:
* 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 committees.
* They will work with the management team within the National Office to develop effective policies, processes and procedures to support the team and their work under the European Union Clinical Trials Regulation (EU CTR No 536/2014),
* 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).
Duties will include:
Operations of the National Office for Research Oversight
* Work with the Head of Office to ensure the unit has adequate resources and skill sets to support committee members and maintain the necessary competencies to operate under relevant legislative frameworks.
* Foster a culture of clear goals, accountability, and professional excellence within the office.
* Contribute to the organization's strategic objectives by developing and implementing the annual work program and managing day-to-day activities of the assigned tea
Strategic and Operational Support for Research Committees
* Take a leadership role in developing and implementing standards, policies, and procedures to strengthen the research ethics review system.
* Develop expertise and provide guidance on ethical issues related to health research and relevant regulatory frameworks to committees, sponsors, and stakeholders.
* Oversee the preparation of meeting agendas and supporting documentation, in consultation with committee chairs.
Formal requirements include:
* 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
* 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
* Knowledge and understanding of research ethics and experience of providing support to an ethics committee or similar committee would be a distinct advantage
Get in touch today