Trainee (HMA-EMA Catalogue of real-world data studies: Are transparency recommendations followed?)

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

Traineeship in the Real World Evidence Office

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.

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 possess a previous degree), who are interested in gaining experience and contributing 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 Real World Evidence Office.

Specific objectives and projects

The Heads of Medicines Agencies-European Medicines Agency (HMA-EMA) Catalogue of real-world data (RWD) studies, launched in 2024, is a centralised publicly available repository of RWD studies from across the globe, with records maintained by study investigators. The RWD study Catalogue aims to enhance transparency and reproducibility in RWD research and support the use of RWD in the context of investigating the use, safety and effectiveness of medicines.

It enables registration of non-interventional (RWD / observational) studies using a structured metadata model supporting consistent cataloguing across the study lifecycle. Metadata represent key study characteristics, including study design, population, outcomes, timelines and data sources used. The RWD study Catalogue supports the registration of study protocols prior to study initiation, with the possibility to upload multiple versions to document amendments over time. The upload of study results and other study resources is also highly encouraged. It is openly accessible and supports free-text search, filtering, and export functions.

As of December 2025, the RWD study Catalogue hosts 3,238 studies distributed across various regions, with 62% conducted exclusively in European countries. On average, 25 new studies are added per month. Voluntary registrations account for 56% of the studies, while the remainder are regulatory-mandated. Studies span all lifecycle stages, with currently 462 classified as planned, 931 ongoing, 1,833 completed and 12 discontinued or cancelled. Of these studies, 59% include a study protocol, and 50% provide additional study materials such as results or links to external repositories containing analytical code.

These descriptive statistics showcase the contribution of the RWD study Catalogue in improving transparency in RWD research, but they also highlight some of the limitations that we would like to further explore. With this in mind, the trainee will:

• be involved in identifying the studies according to a clear cut-off date and lifecycle stage (based on clear inclusion and exclusion criteria);
• contribute to a review of recorded documents (protocol as from ongoing stage, report as from finalised stage), according to source of funding (public / private), disease area, study type;
• describe the timing of availability, assessing whether there is a trend towards improvement (quicker availability after study start and / or finalisation) and the type of information missing;
• contribute to recommendations on how this could be improved based on the analysis performed to inform the process (including through discussions with some of our stakeholders, such as industry via the focus group on RWD/RWE), with the ultimate aim of identifying whether adaptations to the process may be needed and communicating these findings clearly to our stakeholders.

This activity will be important as, by improving discoverability and traceability of RWD studies, the RWD study Catalogue supports study planning, knowledge sharing, reproducibility, and promotes good research practices.

Learning outcomes

• Understand how complete the RWD study Catalogue is when it comes to recommendations on proper study documentation (protocol and report upload).
• Identify and assess factors that may influence this transparency effort.
• Assess current limitations (process-related or not) and discuss with some stakeholders to understand how this could be improved so that the impact of the registered studies is optimised to support EMA (and other stakeholders) activities.
• Gain knowledge of the Agency’s processes and procedures in the support to the generation of real-world evidence for regulatory decision making.

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 pharmacoepidemiology, biostatistics, medicine, pharmacy or biology (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;
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.

Additional skills

Demonstrated experience in data analysis, clinical research, or regulatory processes, combined with a strong interest in real-world data/evidence with skills in analytics.

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.