• Collaborate with stakeholders in clinical development to identify and document business and functional requirements for IT systems.
• Translate clinical development needs into detailed IT specifications, focusing on systems such as EDC (Electronic Data Capture), e TMF (electronic Trial Master File) and CTMS (Clinical Trial Management System).

• Map out and document current clinical development processes, identifying inefficiencies or opportunities for improvement.
• Propose and implement IT solutions to optimize clinical trial processes, enhancing efficiency and data quality.

• Evaluate, recommend, and support the implementation of IT systems that meet the needs of the clinical development team

• Ensure successful system integration, data migration, and customization, working closely with IT and clinical teams.

• Understand customer and key stakeholders interests and concerns and guide and provide solutions to customers and key stakeholders
• May convince others to accept new concepts, practices, and approaches
• Assist in change management processes, providing support during transitions to new systems or processes.
• Prepares presentations and concepts to be presented to the functional community or leadership team

• Lead or participate in system validation activities to ensure compliance with industry regulations (e.g., Gx P, 21 CFR Part 11).
• Monitor ongoing compliance of IT systems, collaborating with QA and regulatory teams to address any issues.

• Develop and deliver training materials and sessions for clinical development teams, ensuring effective use of IT systems.
• Provide ongoing technical support and troubleshooting, working with IT support teams as needed.

• Collaborate with data management teams to ensure high data quality in clinical systems.
• Define reporting requirements and assist in designing reporting solutions that provide insights into clinical trial progress.

• Coordinate IT projects within the clinical development area, ensuring timely and within-budget delivery.
• Identify and mitigate project risks, maintaining a proactive approach to problem-solving.

• Stay informed about new technologies, industry trends, and regulatory changes impacting clinical development.
• Propose innovative IT solutions to enhance clinical trial efficiency, data integrity, and patient safety.

• Manage relationships with external vendors, participating in the evaluation, selection, and management of third-party software and service providers.
• Assist in contract negotiations and reviews to ensure alignment with business and technical requirements.

• Individual contributor who may manage employees (rarely)
• May review the work and supervise other junior employees and validate peer's work (including external suppliers)

• Proven experience as an IT Business Analyst in the clinical development or related R&D areas (Medical Affairs, for instance).
• Strong understanding of clinical trial processes and related IT systems (e.g., EDC, CTMS, e TMF, e ISF, RTSM, RBQM, e COA, e Consent, Imaging) and software development lifecycle (SDLC)
• Experience managing IT projects in a regulated environment, with knowledge of Gx P, 21 CFR Part 11, and other relevant regulations.
• Fluent in English
• Excellent communication and stakeholder management skills.
• Experience with system validation, process optimization, and project management.
• Familiarity with AI technologies such as natural language processing (NLP), predictive modelling, and machine learning algorithms applied to Clinical or Medical areas.
• Business Analysis certifications (e.g., CBAP, CCBA) or Project Management certifications (e.g., PMP, PRINCE2) are a plus.

• You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
• You will receive a competitive compensation package with bonus structure and extended benefit package.
• You will be able to work in a hybrid work culture.
• You will participate in feedback Loops, during which a personalized career path will be established.
• You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability.

• Send your CV in English.
• If your profile is a match, we will invite you for a first virtual conversation with Talent Acquisition.
• The next step is a virtual conversation with the hiring manager.
• The final step is a panel conversation with the extended team.