Trainee (Change management in use of patient-level clinical study data)

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in Amsterdam. It is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.

Traineeship opportunity

Trainee (Change management in use of patient-level clinical study data)

The Agency is looking for motivated, qualified recent graduates or students on an Erasmus+ or other programme or PhD students or Master's students (who posses a previous degree), who are interested in gaining experience and contribute to the Agency’s work for every patient in Europe. The purpose of a traineeship at the Agency is to perform tasks that are predominantly in the interest of the trainee’s training and principally serve to increase the trainee’s knowledge and to gain relevant experience.

Placement description

We are looking for a trainee in the Methodology Office.

Specific objectives and projects

During the traineeship, the trainee will work on projects to support the transformation of the European Medicines Regulatory Network (EMRN) into a more data-driven regulatory network. The trainee will be involved in the development and implementation of change management activities (e.g. trainings, communication, review of guidance and requirements) on the use of clinical study data (individual patient data in electronic structured format) as part of the ongoing CHMP pilot. This will include fine-tuning of the change management framework with a focus on stakeholder engagement, communication and training activities.

The role requires regularly liaising with a wide range of stakeholders including different EMA functions, national competent authorities, members of the Agency's scientific Committees and Working Parties, as well as international regulatory agencies.

The trainee will also contribute to the preparation of the final pilot report summarising the learnings of the pilot and recommendations for future systematic submissions of clinical study data.

Finally, the trainee will contribute to knowledge management activities for the Methodology Working Party (MWP) and Methodology European Specialised Expert Community (ESEC), e.g. by collecting, curating and sharing information on scientific outcomes (expected time: approx. 20%) and developing technical solutions for efficient sharing of such information.

Learning outcomes

• Understanding how access to and use of clinical study data can support medicine evaluation
• Development and application of effective change management strategies in a complex regulatory environment
• Understanding the operations of the European Medicines Regulatory Network and its stakeholders, including other international regulatory agencies (e.g. US FDA, Japan PMDA)
• Working in an interdisciplinary project team, contributing to its objectives through individual tasks and collaboration
• Understanding various aspects of knowledge management and how to implement them in a complex scientific environment
• Development of networking skills in a multi-stakeholder regulatory environment

Eligibility criteria

To be eligible for consideration for this placement, you are required to:

1. enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway;
2. possess a university degree in business management, psychology, communications, change management, or policy linked to innovations (minimum of three years or more) that must have been obtained between 6 May 2025 and 6 May 2026 or be a university student on an Erasmus + or a similar programme or a PhD student or a Master's student with a previous fully finished degree in the areas mentioned before. A university degree in biostatistics/epidemiology, data science or medicine/pharmacy could also match if the candidate has also good communication skills.
3. a thorough knowledge of English (at least level C1) and good knowledge of other official EU language (at least B2)

Additional skills

• Experience in international environments and networks
• Good communication skills
• Knowledge of Agile methodology
• Organisational skills

Behavioural competencies

You will demonstrate the following behavioural competencies:

• Communication skills
• Interpersonal skills
• Working with others
• Adaptability
• Research and analytical skills
• Learning and development

Conditions of traineeship

The traineeship is offered for 10 months (1 October 2026 – 31 July 2027) and takes place at the Agency’s premises in Amsterdam with possibility for teleworking up to 40% of working time from The Netherlands and occasional teleworking from outside The Netherlands. Traineeships are offered for either full-time or part-time (80% or 50%) if combined with university studies.

The Agency pays a monthly stipend of €2,049.77 for a full-time traineeship (reduced accordingly for 80% or 50%) and a travel contribution upon joining the Agency.

Each trainee will have a mentor at the Agency who will guide the trainee through the programme.

What we offer

• Meaningful work contributing to protecting the health of every individual and animal in Europe within multinational, multidisciplinary team
• Development opportunities (e.g. internal mobility, mentoring, peer coaching, career reflection programme, etc.)
• Work-life balance (flexible working arrangements, teleworking, generous annual leave plus official holidays)