It Business Analyst – Clinical Development

hace 2 meses

Barcelona, España Galderma Pharma S.A A tiempo completo

IT Business Analyst – Clinical Development Location: Barcelona

Job Description We are looking for an experienced IT Business Analyst to support our R&D Clinical Development team. In this role, you will be responsible for bridging the gap between IT and clinical research teams, ensuring that our technology solutions effectively support our clinical trial processes. The ideal candidate will have a strong background in both IT and clinical development, with the ability to translate complex business needs into actionable IT requirements.

Key Responsibilities Requirements Gathering and Analysis 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), eTMF (electronic Trial Master File) and CTMS (Clinical Trial Management System). Process Mapping and Optimization 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. System Implementation and Integration 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. Stakeholder Management Understand customer and key stakeholders interests and concerns and guide and provide solutions to customers and key stakeholders. Assist in change management processes, providing support during transitions to new systems or processes. Prepare presentations and concepts to be presented to the functional community or leadership team. Validation and Compliance Lead or participate in system validation activities to ensure compliance with industry regulations (e.g., GxP, 21 CFR Part 11). Monitor ongoing compliance of IT systems, collaborating with QA and regulatory teams to address any issues. Training and Support 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. Data Management and Reporting 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. Project Management 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. Continuous Improvement 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. Collaboration with Vendors 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. Management Responsibility Individual contributor who may manage employees (rarely). May review the work and supervise other junior employees and validate peer's work (including external suppliers). Skills & Qualifications 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, eTMF, eISF, RTSM, RBQM, eCOA, eConsent, Imaging) and software development lifecycle (SDLC). Experience managing IT projects in a regulated environment, with knowledge of GxP, 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. What we offer in return 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. Process steps 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. Our people make a difference At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

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