Trainee (Knowledge management for clinical trials)

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 Transformation Office within the Data Analytics and Methods Task Force.

Specific objectives and projects

During your traineeship, you will be involved in two projects which centre around the development of training signposting and knowledge sharing. The planned time per project is indicative with some possibility to amend based on the profile and interest of the selected trainee.

1) In relation to the activity of the Methodology European Specialised Expert (ESEC) Community which brings together experts in the field of Artificial Intelligence and Data Science, Biostatistics, Clinical Pharmacology, Modelling and Simulation, Pharmacogenomics and Real World Data  (50%), you will contribute to:

• Knowledge management strategies: develop & assess effective knowledge sharing formats within the ESEC; establish sign posts and roadmaps for training and development opportunities within/outside the ESEC; create best practice guidance and templates for knowledge sharing and training activities within the Methdology ESEC
• Communication strategies: Assess and improve current communication strategies within the ESEC and with the wider European Medicines Regulatory Network (EMRN); create best practice guidelines and templates for communication items
• Stakeholder engagement strategy: develop and implement communication strategy with external stakeholders of the Methodology ESEC; support workshops and interactions with external stakeholders 

2) In relation to the activity of the Accelerating Clinical Trials in the EU (ACT EU) clinical trials transformation programme (50%), you will contribute to:

• Knowledge management strategies: development of a signposting of available training resources to support non-commercial sponsors conduct clinical trials, working closely with the ACT EU team to enable the conduct of more multinational clinical trials; 
• Develop a process for the collection of structured feedback from stakeholders, and updates from the European Medicines Regulatory Network (EMRN), to enable the maintenance & update of the signposting.

Learning outcomes

In this traineeship, your learning outcomes will be: 

- Understanding of the European Medicines Regulatory Network
- Understanding of the Methodology Domain, i.e. the activities of the Methodology Working Party (MWP) and of the related European Specialised Scientific Expert (ESEC) Community
- Understanding of the impact and importance of communication strategies as part of a change management process
- Gain skills to communicate effectively via written procedures
- Understanding various aspects of knowledge management and how to implement them in a complex scientific environment
- Understanding the needs and ongoing acitivities to support academic sponsors conduct multi-national clinical trials
- Understanding the activity of the ACT EU programme
- 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 communication, business, change management, and policy linked to innovations or in medicine/pharmacy, biostatistics/epidemiology (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 knowledge of clinical trials and experience in academic clinical research

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.