Trainee (Enhancing data use and impact assessment to accelerate clinical trials in the EU)

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 Data Analytics and Methods Task Force.

Specific objectives and projects

The trainee will undertake a project aligned with the "Accelerating Clinical Trials in the EU (ACT EU) priority action on clinical trial analytics. The project will include the following key components:

Identification of structured and unstructured data fields in the Clinical Trials Information System (CTIS)
This activity will involve reviewing the CTIS to identify relevant data fields, both structured and unstructured. The output will be a comprehensive recommendation report on data optimisation or potential gaps for further exploration.

Impact assessment linked to the ACT EU workplan
This part of the project will assess the impact of key initiatives under the ACT EU workplan, including:
a) Flexible approaches to clinical trial design and conduct
Investigating the use of decentralised elements in clinical trial protocols, both before and after the launch of the EU Recommendation paper on decentralised elements in clinical trials (DCT), to assess the paper’s impact and track trends in the adoption of decentralised methodologies.
b) Analysing the uptake of low-interventional trials, as well as pragmatic and large simple trials, to identify challenges in their assessment and key barriers to adoption.
c) Analysis of requests for information (RFIs)
The trainee will analyse RFIs submitted as part of the clinical trial assessment to track ongoing improvements related to the workplan actions, providing insights into how these actions are facilitating progress in the clinical trials landscape.

Learning outcomes

The learning outcomes of this traineeship project will be: 

- Develop an understanding of the Clinical Trials Information System (CTIS) to understand both content and workflow of the system
- Gain a broad understanding of the Clinical Trial Regulation
- Gaining experience in clinical trial data management and analysis, distinguishing between structured and unstructured data and identifying gaps in clinical data.
- Increased understanding of innovative clinical trial designs and methodologies, gaining insight into the evolving landscape, regulatory changes, practical applications, and challenges in their implementation
- Gaining skills in conducting impact measurement and policy evaluation, evaluating the effectiveness of new initiatives and monitoring trends
- Gaining skills in reporting and presenting analytical findings, helping to communicate complex data insights to a broad audience.
- Develop networking skills in a complex 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 data science, statistics, biostatistics, applied mathematics, or a related field, preferably with coursework or a focus on clinical trials, regulatory affairs, or healthcare data analytics or life sciences (minimum of three years or more) that must have been obtained between 6 May 2024 and 6 May 2025 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

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 using AI techniques in analysing unstructured data is very beneficial

Behavioural Competencies

You will demonstrate the following behavioural competencies:

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

Expected selection timelines

Conditions of traineeship

The traineeship is offered for 10 months (1 October 2025 – 31 July 2026) 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 €1,942.19 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.