Clinical Trials Systems Officer (CTIS)

Location: Amsterdam, The Netherlands; relocation to the Netherlands is mandatory

Salary: €4,249.97 net per month, including local weighting, based on a full-time 40-hour contract

Company

The hirify.global is a decentralised European Union agency responsible for evaluating and supervising medicines and supporting public health.

What you will do

• Contribute to the development and optimisation of the Clinical Trials Information System (CTIS) and implementation of the Clinical Trial Regulation.
• Translate business requirements into IT specifications, review functional specifications, and support analysis and design sessions.
• Validate CTIS functionality, test business requirements, escalate issues, and contribute to training materials as a subject matter expert.
• Support communication, stakeholder engagement, and change management for CTIS, the Biotech Act, and ACT EU initiatives.
• Conduct data analysis and reporting to support EMA, the European Medicines Regulatory Network, and regulatory decision-making.
• Work with EU member states, the European Commission, sponsors, IT providers, and EMA legal services.

Requirements

• Eligibility to work as an EU agency contract agent: full rights as a citizen of an EU Member State, Iceland, Liechtenstein, or Norway.
• English at C1 level and satisfactory knowledge of another official EU language at B2 level.
• University studies of at least three years in life sciences, such as biology, chemistry, biochemistry, pharmacy, or medicine.
• At least two years of experience in research, development, manufacture, regulation, authorisation of medicines, or clinical trials.
• Experience translating business requirements into IT specifications, validating requirements, and analysing scientific or regulatory information.
• Strong prioritisation and organisational skills, with demonstrated analytical, communication, collaboration, and adaptability competencies.

Nice to have

• Master’s degree or PhD in medicine or life sciences.
• Experience in data management, data analysis, regulatory affairs, clinical practice, or multinational stakeholder management.
• Experience testing AI-enabled solutions or working with digital and AI-enabled systems.
• Experience with analytics, visualisation, statistical, or programming tools such as R, Python, SQL, Power BI, Tableau, SAS, or Oracle BI.

Culture & Benefits

• Work in multidisciplinary and multinational teams across EMA, national competent authorities, and the European Commission.
• Meaningful work supporting the safety and quality of medicines in Europe.
• Flexible working arrangements, teleworking, generous annual leave, and official holidays.
• Development opportunities including internal mobility, mentoring, and peer coaching.
• Five-year renewable contract in principle, tax-free salary, health insurance, pension plan, allowances, and relocation assistance.

Hiring process

• Eligible candidates are shortlisted using application questions based on the required criteria and competencies.
• Assessments may include remote tests, personality and cognitive assessments, interviews, and evaluation of motivation and role-related EU knowledge.
• Successful candidates may be placed on a reserve list and contacted for an additional interview when a vacancy becomes available.