Trainee (Building an AI-powered CTIS knowledge base)

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 Clinical Trails Systems Office within the Data Analytics and Methods Task Force.

Specific objectives and projects

During your traineeship, you will be involved in building an interactive Clinical Trials Information System (CTIS) knowledge database.

The Clinical Trials Information System (CTIS) was built to implement EU pharmaceutical law in the Clinical Trials Regulation (CTR, Regulation (EU) No 536/2014). It supports interactions between clinical trial sponsors and regulatory authorities in the EU Member States and EEA countries, throughout the lifecycle of a clinical trial.

At European Medicines Agency (EMA, the Agency) CTIS team supports CTIS end-users by responding to user’s questions which might be related to CTIS functionalities and to implementation and interpretation of CTR. The users can use different channels to request for this kind of support, such as CTIS service desk, AskEMA portal, walk-in-clinics events, etc.  

Existence of different repositories where these questions and answers are stored slows down the process of responding to incoming questions. In addition, current way of working adds to higher chance of providing an answer which is not completely in line with answers provided in the past. 

The trainee will contribute to build an interactive CTIS knowledge base which will be based on large language model (LLM), such as OpenAI. 

This interactive CTIS knowledge base will encompass all the knowledge on CTIS and CTR in form of queries received from CTIS end users. Building of this knowledge base will support CTR implementation as it will be crucial in increasing the speed of support provided to the CTIS end users with CTIS and CTR related questions via harmonised advice. 

More specifically, as a trainee in this project you will contribute to: 
-    Mapping of existing knowledge sources (static and living).
-    Preparation of the data and data categorisation.
-    Setting up mechanism for ingestion of the data from living data sources.
-    Validation of results via training of the algorithm (large language model, OpenAI). 

In addition, you will contribute to monitoring of the European clinical trials environment via building the automation of the key performance indicators (KPIs) report under CTR. More specifically you will contribute to:
-    Developing business intelligence (BI) data scripts. 
-    Generating visualisations that will automatically feed into the KPI report.
 

Learning outcomes

In this traineeship, your learning outcomes will be: 

- Gaining a good understanding of the principles to follow for drafting a strategic planning document in the context of data science. 
- Develop networking and communication skills at an international level with multiple stakeholders.
- Understand medicinal product information and the structuring of its information, along with its use in other connected use cases (e.g.: signal detection, PSUR, referrals, pharmacovigilance fee)
- Develop a good understanding of ISO processes for the definition of international data standards. Learn the ISO IDMP standards. 
- Gaining of knowledge and expertise in running of Agile projects

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 applied mathematics, statistics, computer sciences, engineering or a related field, preferably with experience in Python, or life sciences (minimum of three years or more) that must have been obtained within the last 12 months (graduated between 20 May 2023 and 20 May 2024) 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

In addition to the eligibility criteria, you will have:

• Interest in data analytics.
• Excellent reading, writing and verbal ability in English.
• Excellent communication and organisation skills.
• Proven analytical skills, e.g. experience with data analytical software and visualisation tools in an academic/industry environment.
• Experience with clinical trials and understanding of the EU medicine regulatory system is a plus.

Behavioural Competencies

You will demonstrate the following behavioural competencies:

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

Expected selection timelines

Conditions of traineeship

The traineeship is offered for 10 months (1 October 2024 – 31 July 2025) 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 €1,858.31 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.