Clinical Trials Systems Officer

Job grade: FGIV

Internal job grade:

Type of position: Contract agent

Selection procedure reference: EMA/CA/11583

Job title: Clinical Trials Systems Officer

Talent Pool: FGIV Science & Regulation

Deadline for applications: 20 October 2026 at 23.59 CET

Monthly Net Salary: 4,249.97 Euro (including local weighting) [1]plus benefits (see calculators on the right) (based on a fulltime contract (40hrs/week))

Location: Amsterdam; The Netherlands (relocation to take up duties is mandatory)

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About this role

The European Medicines Agency is a decentralized body of the European Union with all its offices and Headquarters based in Amsterdam, the Netherlands. Its core responsibility is the protection and promotion of public health through the evaluation and supervision of medicines.

The European Medicines Agency (EMA) operates and develops the Clinical Trials Information System (CTIS) and works with the National Competent Authorities (NCAs) and the European Commission (EC) on the implementation of the Clinical Trial Regulation (EU) No 536/2014 (CTR) including support to the Clinical Trials Coordination Group (CTCG). CTIS is undergoing a process of optimisation. The recent proposals of the Biotech Act (BTA) have accelerated the timelines of this optimisation. The Agency is also working with the NCAs for medicines and the European Commission to optimise the EU clinical trials environment and this is being coordinated through Accelerating Clinical Trials in the EU (ACT EU) the EU transformation programme for clinical trials.

The position will involve contributing to the further development and optimisation of CTIS, including in preparation for upcoming regulatory initiatives such as the Biotech Act. Additionally, the position may also require:
• supporting the design and implementation of activities under the ACT EU programme, in relation to CTIS business intelligence;
• contributing to communication and change management activities related to CTIS and ACT EU;
• providing data analysis and insights to support EMA and the European Medicines Regulatory Network (EMRN);
• strengthening support to the CTCG and to large multinational clinical trials, including initiatives such as FAST-EU and the pre-CTA consolidated advice process.

In this role you will

Working within the EMA Data Analytics and Methods Task Force you will be part of multidisciplinary teams at EMA and across the National Competent Authorities and European Commission. You will contribute to strengthening and transforming the European clinical trials environment, supporting key regulatory, scientific, and operational activities. These activities are especially focused on supporting the oversight as well as contributing to the implementation of the revised CTR by the BTA by advising and supporting the development of the Clinical Trial Information System (CTIS).

Depending on the specific position, you may:

• interact with different stakeholders (EU member States, European Commission, sponsor representatives, IT providers, EMA legal service) to provide business input in the following CTIS project/programme activities:
• Analysis & design (AD) session and raise any issues that may arise during the A&D session
• Review of the functional specifications related to CTIS development
• Verify business validations (testing of CTIS) and escalate any issues that may arise
• Support development of CTIS training material as subject matter expert
• Provide input and testing for AI related enhancements in CTIS;
• provide responses to external queries on CTIS related matters;
• support communication, stakeholder engagement, and change management activities to promote effective use of CTIS, the upcoming implementation of the Biotech Act and broader ACT EU initiatives;
• conduct data analysis to inform stakeholder needs and support decision-making across EMA and the EMRN.

Link the full role description of the Scientific Officer outlining generic duties and responsibilities.

Apply if you fulfil these eligibility criteria

To be eligible for consideration for this position, you are required to meet the following general and specific eligibility conditions:

General conditions:
1. Enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein, or Norway;
2. Have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2);
3. Have fulfilled any obligations imposed by applicable laws concerning military service.

Specific condition:
1. A level of education which corresponds to completed university studies of at least three years in Life Science (e.g. biology, chemistry, biochemistry, pharmacy, medicine), attested by a diploma that must have been obtained by the closing date of this vacancy notice.

General Condition 1 and Specific Condition 1 will be verified firstly based on the application form and then you will be required to provide documentary evidence at the interview stage. Failure to present these documents may result in the disqualification from the selection procedure.

Only eligible candidates will be assessed by the Selection Committee.

You will need

Experience

• A minimum of 2 years of experience in the fields of research, development, manufacture, regulation or authorisation of medicines or clinical trials;
• Experience in translating Business requirements into IT Specifications and validating those requirements;
• Experience in information analysis and reporting on scientific/regulatory matters;

Skills & Knowledge

• Excellent Prioritising and Organisational skills;

Competencies you need to have:

Sub-family competencies
Regulatory frameworks & strategy Basic
Scientific evidence management Basic
Scientific product lifecycle and procedure management Basic
Applied knowledge management Basic

Grade competencies
Adaptability and agility Intermediate
Coping with pressures and setbacks Intermediate
Analysing and problem solving Intermediate

Core competencies
Ethics and integrity Intermediate
Team collaboration Intermediate
Customer centricity Intermediate
Results orientation Intermediate
Communication Intermediate
Cross-cultural sensitivity Intermediate
Continuous learning and self-development Basic

For more information about definitions of competencies and associated proficiency levels, please refer to the EMA Competency Framework.

These are considered as Nice to Have

Education

• Masters in a relevant field of study (Medicine or Life sciences);
• Completed PhD or master’s degree in one of the university degrees required for eligibility.

Experience

• In data management and data analysis;
• In testing and validation of AI-enabled solutions or knowledge of Digital/AI enabled systems;
• In regulatory affairs on EU-wide or national procedures or other work on the regulation of medicines;
• In information analysis and reporting on scientific/regulatory matters;
• Clinical experience in a therapeutic field;
• In working for a multinational organisation and managing multiple international stakeholders;
• Nonclinical experience in a Good Laboratory Practice (GLP) laboratory.
• In coordination of research projects;
• In working in a regulatory environment related to the evaluation of medicines or interacting with regulatory agencies;
• In delivering, implementing and using data analytics solutions which include Artificial Intelligence components;
• In data analytics frameworks based on cloud technologies, with tools used in analytics and data visualisation such as R, Python. Power BI or Tableau.
• Using statistical software (for instance R, SAS, etc.) and programming languages used in analytics (for instance SQL, PL-SQL, Python, R, etc.);
• Experience with Data visualisation and usage of data visualisation tools (for instance Tableau, R Shiny, Oracle BI, Power BI, etc.);
• Knowledge of data collection and practices with data analysis tools;

Selection procedure timelines

Deadline for applications | 14 October 2026 at 23:59 CET

Preliminary Assessments | First week of November 2026

Final assessments | Last week of November 2026

Decision expected | December 2026

Selection process

Only eligible candidates (see eligibility criteria) will be assessed by the selection committee.

Suitability and qualifications of eligible candidates will be assessed against the assessment criteria and competences in different steps of the selection procedure.

Note: Candidates who fail any assessment linked to any Need to Have requirement, Sub-family, grade specific competencies, and Core Competencies at any stage of the process are disqualified, despite getting points on other criteria.

Before the start of the selection procedure, it is decided which criteria and competences will be assessed at each stage of the process. Certain criteria / competences will be assessed / scored only for shortlisted candidates during interviews (and/or tests). Please consult the Careers at EMA - Guidance on selection and recruitment (section 1.3. selection procedure) for an overview of the criteria and competences assessed at each stage of the process.

Shortlisting

In order to allow the selection committee to carry out an objective assessment of all candidates in a structured way, as part of their application, all candidates must answer the pre-defined set of questions based on Need to have criteria and sub-family competences/Core competencies.

The Selection Committee will therefore assess eligible candidates using the information provided in the responses to those questions and in their application. When answering a question, you should include all relevant information, even if it is already mentioned in other sections of your application form.

To carry out this assessment, each of your responses will be awarded points (0 to 10). The points are added up to identify those candidates whose profiles best match the duties to be performed as advertised in the vacancy notice.

Only the candidates with the highest total marks at the shortlisting stage will progress to the next stage. The Selection Committee will decide to limit the number of candidates invited to the next stages. Please consult the Careers at EMA - Guidance on selection and recruitment (table on section 1.3.6 Preliminary and final assessments) for an overview of the thresholds.

Assessments

Next steps of selection may include a preliminary assessment. Most assessments will be conducted remotely (i.e. Webex/Teams, remote test, etc.). All assessments are based on the assessment criteria listed in this vacancy notice.

Shortlisted candidates will participate in personality assessments (e.g. SHL occupational personality questionnaire OPQ32) to assess their Core Competencies (pass score is 26 out of 100 points and above). In addition, selected Core Competencies may be assessed throughout the process.

Additional assessments, such as cognitive (e.g. deductive reasoning) assessments might also be foreseen as part of the selection process. Furthermore, motivation and overall fit for the job and knowledge of EU relevant to role may be assessed.

Please consult the Careers at EMA - Guidance on selection and recruitment (section 1.3.3 selection procedure) for an overview of the criteria and competences assessed at each stage of the process and the type of assessment tolls used.

Reserve list and/or job offers

The aim of this selection procedure is to create a reserve list of qualified and suitable candidates. Each candidate having reached the final step of the selection procedure will be notified via e-mail whether she/he has been placed on the reserve list, and relevant Talent Pool. Candidates should note that the placement on a reserve list and/or Talent Pool does not guarantee an employment offer.

We strongly encourage that candidates do not apply for the vacancies that are at the same grade and the same subfamily as the Talent Pool they have been placed on, as this will not improve their chances of being considered for a vacant post within the Agency.

When a vacancy becomes available, candidates on the reserve list may be contacted for an additional interview.

More information about selection and recruitment (including administrative complaint procedure) at the EMA is available at our careers website.

Conditions of employment

In principle, the Agency offers a five-year renewable contract. Contracts of a shorter duration may be offered to the candidates.

The successful candidate will be required to relocate to the Netherlands to pick up duties.

[1] The local weighting adjusts salaries to the cost of living in the Netherlands compared to Brussels. The current weighting for the EMA's location in Amsterdam, the Netherlands, is 113.2. Please consult the Eurostat and Commission websites for more information on weightings.

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Domenico Scarlattilaan 6 - 1083 HS Amsterdam - The Netherlands

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

© European Medicines Agency, 2025. Reproduction is authorised provided the source is acknowledged.