INTERNSHIP DETAILS

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

CompanyEMA
LocationAmsterdam
Work ModeOn Site
PostedApril 10, 2026
Internship Information
Core Responsibilities
The trainee will support the transformation of the European Medicines Regulatory Network into a data-driven network by developing and implementing change management activities related to the use of individual patient clinical study data. This includes fine-tuning the change management framework, liaising with stakeholders, preparing a pilot report, and contributing to knowledge management activities.
Internship Type
full time
Company Size
1687
Visa Sponsorship
No
Language
English
Working Hours
40 hours
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About The Company
The European Medicines Agency (EMA) is a decentralised body of the European Union with headquarters in Amsterdam. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.
About the Role

Selection procedure reference: EMA/TR/11382 

Deadline for applications: 06 May 2026 23:59 CET 

 

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in Amsterdam. It began operating in 1995. It is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.

 

This traineeship opportunity is now open for applications until 06 May 2026 23:59 CET, with an intake on 1 October 2026.

About the traineeship programme

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

The learning outcomes will be:
 
• 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) of the Common European Framework for Languages

 

For criteria 1 and 2, you will be required to provide proof in the application form and at the interview stage. Failing to present these documents may result in the disqualification from the procedure.

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.

The conditions of employment are stated in the Executive Decision on rules governing the traineeship programme at the EMA available here.

Expected selection timelines

Deadline for applications 06 May 2026 23:59 CET 
Assessments (remote)From mid-June 2026 to mid-July 2026
Decision and offers By end of July 2026
Placement start 1 October 2026

 

______________________________________________________________________________________________________

Domenico Scarlattilaan 6 - 1083 HS Amsterdam - The Netherlands

Telephone +31 (0)88 781 6000 - Email recruitment@ema.europa.eu

 

© European Medicines Agency, 2024. Reproduction is authorised provided the source is acknowledged.

Key Skills
Change ManagementStakeholder EngagementCommunicationTrainingData-Driven Regulatory NetworkClinical Study Data UseRegulatory EnvironmentInterdisciplinary Project TeamKnowledge ManagementAgile MethodologyOrganisational SkillsInterpersonal SkillsAdaptabilityResearch And Analytical SkillsLearning And Development
Categories
HealthcareGovernment & Public SectorScience & ResearchAdministrativeConsulting
Benefits
Travel Contribution