Requirements Engineer - Clinical Trial Systems

Merck Healthcare; Mollet del Vallès; On-site; EUR 65,000 - 90,000; Full time

Job summary

Merck Healthcare is seeking a Requirements Engineer for Clinical Trial Systems to translate evolving business needs into precise system requirements, enabling faster, compliant trial execution across the organisation. You will own the review, improvement, and creation of Functional Requirement Specifications, ensuring alignment with business intent and technical feasibility.

This role sits at the intersection of clinical operations and IT, driving governance and traceability.

Qualifications

• 5+ years as a Business Analyst in cross-functional environments.
• 3+ years hands-on in clinical trial data and processes.
• Facilitates requirement workshops and stakeholder reviews.
• Experience with data platforms, APIs, and system integrations.
• Familiar with Good Practice standards for clinical data systems and change control.
• Strong analytical skills with meticulous attention to detail.
• Degree in IT/Life Sciences/Business or equivalent experience.
• Demonstrates AI literacy and ethical considerations in AI tools.

Responsibilities

• Own the review, improvement, and creation of Functional Requirement Specifications.
• Identify gaps, resolve ambiguities, and simplify complex business rules.
• Facilitate structured requirement reviews with cross-functional stakeholders.
• Drive documentation standards, traceability, and governance across platforms.

Skills

Requirement gathering

Stakeholder facilitation

Analytical thinking

AI literacy

Attention to detail

Education

Degree in IT/Life Sciences/Business

BA/Certification in BA (advantage)

Tools

APIs

System integrations

Data platforms

Job description

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role:

at the heart of clinical data management lies a critical challenge: turning complex, evolving business needs into precise, actionable system requirements. As a Requirements Engineer for Clinical Trial Systems, you will play a pivotal role in shaping the quality and integrity of a global Operational Data Repository programme — directly enabling faster, more reliable clinical trial execution across the organisation.

In this role, you will own the review, improvement, and creation of Functional Requirement Specifications, ensuring they are precise, complete, and aligned with both business intent and technical feasibility. You will identify gaps, resolve ambiguities, and simplify complex business rules without losing their essential meaning. Working at the intersection of clinical operations and information technology, you will facilitate structured requirement reviews with cross-functional stakeholders and drive meaningful improvements to documentation standards, traceability, and requirement governance. Your work will directly influence the reliability and scalability of the data platforms that underpin clinical trial operations.

Who You Are

• You bring 5 or more years of experience as a Business Analyst, with a strong track record of delivering high-quality requirement specifications in complex, cross-functional environments. A professional certification such as Certified Business Analysis Professional, PMI Professional in Business Analysis, or International Requirements Engineering Board certification is an advantage.
• You have 3 or more years of hands-on experience with clinical trial data and processes, giving you a solid understanding of how data flows through clinical operations and what is required to support compliant, audit-ready systems.
• You are skilled at facilitating requirement workshops and stakeholder reviews, translating diverse perspectives into clear, consistent, and actionable documentation.
• You have practical experience working with data platforms, system integrations, and application programming interfaces, and you understand the technical constraints that shape feasible requirements.
• You have worked in regulated environments and are familiar with Good Practice standards applicable to clinical data systems, including the expectations around validation, traceability, and change control.
• You bring strong analytical skills and a meticulous attention to detail, with the ability to identify inconsistencies, redundancies, and gaps across large sets of requirements.
• You hold a degree in Information Technology, Life Sciences, Business, or a related field, or bring equivalent professional experience that demonstrates the same depth of knowledge.
• You demonstrate AI literacy: you understand how artificial intelligence technologies work, their practical applications and limitations, and the ethical considerations around bias, fairness, privacy, and accountability — enabling you to critically assess AI-driven tools and make informed, responsible decisions in your role.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!