Senior Clinical Data System Designer (Colombia)

Job description

Clinical Database Builder / Technical Designer Location: Colombia Join Bioforum, Where Innovation Meets Opportunity! We’re looking for an experienced Senior Clinical Data Systems Designer with hands-on clinical database build experience to join our dynamic and growing team in Colombia. This position is specifically for a Clinical Database Builder , Technical Designer, or Database Architect who has practical experience designing, configuring, programming, testing, and maintaining clinical trial databases within Electronic Data Capture systems. Please note that experience using EDC systems as a Clinical Data Manager, Data Reviewer, Site User, or general system user is not sufficient for this role. Candidates must have direct, hands-on experience building clinical study databases and configuring study functionality within an EDC platform. If you have database build experience in Medidata Rave, RaveX, Veeva EDC, or another industry-recognized EDC platform and are ready to take the next technical step in your career, we want to hear from you. Why Bioforum? Bioforum is a vibrant, quality-driven company that values innovation, collaboration, and the professional development of our employees. You will have the opportunity to work on global clinical studies, collaborate with experienced clinical data professionals, and contribute to the development of smarter, more efficient systems for clinical data collection and management. Minimum Qualifications Bachelor’s degree or higher in biomedical sciences, life sciences, information technology, computer science, engineering, or a related discipline, or equivalent relevant experience. Certification or formal database build training in Medidata Rave, RaveX, Veeva EDC, or another recognized EDC platform is highly desirable. Relevant training or experience in clinical database design and clinical data management is advantageous. Minimum Experience At least 2 to 4 years of hands-on experience as a Clinical Database Builder, Technical Designer, Database Architect, or in a comparable clinical systems build role. Demonstrated experience building, configuring, programming, testing, implementing, and maintaining clinical trial databases. Experience supporting studies throughout the database lifecycle, from initial protocol review and database design through go-live, study maintenance, database lock, and closeout. Experience working with an EDC system only as an end user, Clinical Data Manager, monitor, reviewer, or site user will not be considered equivalent to database build experience. Required Database Build Experience Candidates must be able to demonstrate practical experience in several of the following areas: Building electronic case report forms and associated data fields within an EDC platform. Configuring folders, forms, matrices, visit schedules, events, and subject workflows. Programming automated and manual edit checks or data validation rules. Configuring derivations, calculations, conditional logic, dynamic forms, and field behaviour. Configuring user roles, permissions, alerts, notifications, and study-specific functionality. Translating protocol requirements into functional database designs and technical specifications. Performing unit testing, peer review, and correction of database build components. Implementing protocol amendments and customer change requests within active study databases. Troubleshooting build, configuration, and production issues. Key Skills Strong understanding of clinical trial processes and clinical data management workflows. Practical database build experience in one or more EDC platforms, such as Medidata Rave, RaveX, Veeva EDC, or an equivalent clinical data platform. Ability to interpret clinical study protocols and translate requirements into functional database configurations. Experience designing electronic case report forms, visit schedules, edit checks, derivations, alerts, and study-specific workflows. Understanding of database design standards, data validation requirements, and clinical data quality principles. Knowledge of CDISC standards, including CDASH and SDTM, is advantageous. Experience developing or maintaining standard libraries, reusable forms, edit checks, and database build components. Familiarity with programming or scripting languages such as SQL, VBA, C#, JavaScript, or similar technologies is advantageous. Experience with system integrations, external data transfers, custom reporting, or advanced EDC modules is beneficial. Proficiency in Microsoft Office applications. Language Requirements Strong professional proficiency in spoken and written English is required. Spanish fluency is highly desirable. The successful candidate must be comfortable participating in meetings, preparing documentation, and communicating with global study teams and sponsors in English. Core Competencies Strong analytical thinking and problem-solving abilities. Excellent attention to detail and commitment to quality. Ability to interpret complex protocols, specifications, and technical requirements. Strong planning, organisation, and time-management skills. Ability to manage multiple studies and competing priorities. Effective communication and collaboration with technical and non-technical stakeholders. Ability to work independently while contributing effectively within a global team. A proactive approach to identifying risks, resolving issues, and improving processes. Willingness to learn new platforms, tools, and database design approaches. Key Responsibilities Lead or support the design, configuration, programming, implementation, and maintenance of clinical trial databases in EDC systems. Review clinical study protocols and related documentation to identify database and data collection requirements. Translate protocol requirements into database design specifications, electronic case report forms, visit schedules, edit checks, derivations, and study workflows. Build and configure electronic case report forms and associated fields, folders, matrices, dictionaries, and supporting database components. Program automated and manual data validation checks to support complete, consistent, and high-quality clinical data. Configure calculations, derivations, conditional logic, dynamic functionality, alerts, notifications, role permissions, and study-specific workflows. Apply company, sponsor, and study-specific database standards throughout the build process. Support the use and maintenance of standard form libraries, edit check libraries, and reusable database components. Develop and maintain database design specifications, annotated case report forms, completion guidelines, testing documentation, and other study-related technical documents. Perform unit testing and peer review of database components before formal validation or user acceptance testing. Participate in or lead database validation activities before and after study go-live. Investigate and resolve findings identified during testing, validation, and production use. Manage and implement sponsor or customer change requests for active study databases. Assess the impact of protocol amendments and other changes on existing database configurations. Troubleshoot database build, EDC, integration, and user-related issues. Support database migrations, system integrations, custom reports, data transfers, and advanced EDC functionality. Collaborate with Clinical Data Managers, Configuration Specialists, Statistical Programmers, Project Managers, Clinical Operations teams, and external stakeholders. Work directly with sponsors to clarify requirements, present database designs, resolve technical questions, and provide study-level support. Represent the Clinical Data Systems Design team during internal and client meetings. Support database go-live readiness activities and provide post-production support. Assist with database lock, study closeout, archival, and other end-of-study activities. Support clinical data review, external data reconciliation, and issue resolution when required. Ensure that database development activities are performed in accordance with company procedures, sponsor requirements, applicable regulations, and Good Clinical Practice. Contribute to internal guidance documents, work instructions, templates, and process improvement initiatives. Support the development and review of departmental standard operating procedures. Identify opportunities to improve database build quality, efficiency, consistency, and standardisation. Mentor, supervise, and train junior Clinical Database Builders, Technical Designers, and other team members as required. Apply Now! Are you an experienced Clinical Database Builder ready to contribute to global clinical studies and advanced clinical data systems? Send your CV to the Bioforum team today. Please ensure that your CV clearly describes your hands-on database build experience, including the EDC platforms you have worked with, the study components you have configured, and your specific responsibilities during database development. We’re looking for talented, experienced, and quality-driven Clinical Database Builders based in Colombia who are ready to contribute to the future of clinical trial technology.