SNE/Experts in Clinical Trials

About this role

The European Medicines Agency is a decentralized body of the European Union with all its offices and Headquarters based in Amsterdam, the Netherlands. Its core responsibility is the protection and promotion of public health through the evaluation and supervision of medicines.

We are looking for National experts on secondment. This means staff from other European public-sector bodies can work at the European Medicines Agency (EMA) for short periods of time through the national expert on secondment (SNE) programme. The aim of this programme is to enhance and develop the relationship between European public administrations.

SNEs serve a dual role: they bring their expertise to EMA and take back to their home administration the knowledge acquired during their period of secondment. SNEs remain in the service of their employer. Secondment is not equivalent to employment, nor does it lead to employment by EMA. Periods of secondment may last between six months and two years.
This is renewable once or more, up to a total of four years.

This announcement is governed by the Rules governing the secondment of national experts. For further information please visit our Careers portal.

About these positions:
The Agency is looking to strengthen the support it provides to clinical trials through the secondment of national experts for a period of one to two years (renewable). The Agency is working with the National Competent Authorities (NCAs) for medicines and the European Commission to optimise the EU clinical trials environment and this is being coordinated through Accelerating Clinical Trials in the EU (ACT EU) the EU transformation programme for clinical trials. EMA also operates and develops the Clinical Trials Information System (CTIS) and works with the NCAs and the Commission on the implementation of the Clinical Trials Regulation (CTR) including support to the Clinical Trials Coordination Group (CTCG). A number of positions will be available which might cover:

•    Further strengthening the support to the CTCG and to large multi-national clinical trials following the Clinical Trials Regulation
•    Providing project management to priority actions within ACT EU
•    Clinical trials communications and change management (ACT EU and CTIS) and support to the establishment of a CT multistakeholder platform
•    Clinical trials safety monitoring at EU level (including coordinating CTCG with the Pharmacovigilance Risk Assessment Committee (PRAC) and EudraVigilance)
•    GCP modernisation actions including guidance and training 
•    The further development of the CTIS.

Eligibility criteria

• Enjoy full rights as a citizen of a European Union Member State or Iceland, Liechtenstein and Norway;
• A thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2);
• Be currently employed in the public sector (such as a university, research institute, public hospital or regulatory body) in a European Union (EU) Member State and for the foreseeable time of the tenure as SNE remain in such employment.

You will also need

• Experience of working with clinical trials within a national competent authority, a national ethics body or non-commercial sponsor.

Nice to have

• Change management experience
• Project management experience
• Communications experience
• Training experience
• Experience with business analyses or user support for an IT system