It Business Analyst - Clinical Development

IT Business Analyst - Clinical DevelopmentGalderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin shapes our lives, we are advancing dermatology for every skin story.We look for people who focus on getting results, embrace learning, and bring positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.Further supporting our growth and innovation momentum, we are establishing a new Global Capability Center in Barcelona to deploy new capabilities to effectively support its global commercial and functional teams. Located in the upscale Eixample District in the heart of Barcelona, Galderma's Global Capability Center offers numerous possibilities for professional development such as exposure to global and cross-functional projects and access to global career opportunities.Job Title: IT Business Analyst - Clinical DevelopmentLocation: BarcelonaJob DescriptionWe 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 ResponsibilitiesRequirements Gathering and AnalysisCollaborate 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 OptimizationMap 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 IntegrationEvaluate, 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 ManagementUnderstand customer and key stakeholders' interests and concerns and guide and provide solutions to them.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 ComplianceLead 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 SupportDevelop 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 ReportingCollaborate 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 ManagementCoordinate 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 ImprovementStay 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 VendorsManage 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 ResponsibilityIndividual contributor who may manage employees (rarely).May review the work and supervise other junior employees and validate peer's work (including external suppliers).Skills & QualificationsProven experience as an IT Business Analyst in 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 modeling, 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 returnYou will be working for an organization that embraces diversity & inclusion and believes 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 stepsSend 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 differenceAt Galderma, you'll work with people who are like you and those who are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos create the perfect environment for people to thrive and excel in what they do.
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