Senior Clinical Data Systems Designer - RTSM Specialist (India)

Job description

Technical Designer / Database Architect We’re on the lookout for a Senior Clinical Data Systems Designer with specialist expertise in Randomization and Trial Supply Management (RTSM) to join our dynamic, growing team. The successful candidate will combine strong clinical database design experience with hands-on knowledge of RTSM systems, including study randomization, treatment allocation, investigational product supply management, system integrations, testing, and ongoing study support. If you have experience working with RTSM, IRT, or IWRS solutions and are certified or experienced in Medidata Rave, RaveX, Veeva EDC, or another industry-recognized clinical technology platform, we want to hear from you. Why Bioforum? We are a vibrant, quality-driven company that values innovation, collaboration, and the professional growth of our team. Join us in building smarter clinical systems that support reliable clinical data, effective study execution, and the safe management of investigational products. Minimum Qualifications Bachelor’s degree or higher in biomedical sciences, life sciences, information technology, or a related discipline, or equivalent relevant experience. Relevant training, certification, or demonstrated experience in an RTSM, IRT, or IWRS platform. Certification in Medidata Rave, RaveX, Veeva EDC, or another recognized EDC platform is highly desirable. Minimum Experience 2 to 4 years of experience in a technical designer, database architect, RTSM specialist, or similar clinical systems role. Practical experience designing, configuring, testing, implementing, or supporting RTSM solutions. Experience supporting clinical studies from system design through go-live, maintenance, and study closeout. Key Skills Strong understanding of RTSM, IRT, and IWRS processes within clinical trials. Knowledge of randomization methodologies, including simple, block, stratified, and cohort-based randomization. Understanding of investigational product supply processes, including forecasting, packaging, labelling, inventory management, shipment, dispensing, returns, reconciliation, and destruction. Experience translating protocols and sponsor requirements into RTSM and EDC system specifications. Strong understanding of clinical trial workflows, data standards, study blinding, and controlled unblinding processes. Proficiency in one or more RTSM platforms, such as Medidata RTSM, Suvoda, 4G Clinical, Signant Health, Almac, or another recognized RTSM solution. Proficiency in one or more EDC platforms, such as Medidata Rave, RaveX, Veeva EDC, or an equivalent clinical data platform. Familiarity with system integrations between RTSM, EDC, CTMS, eCOA, central laboratories, depots, and other clinical systems. Familiarity with programming or scripting languages such as SQL, VBA, C#, or similar technologies is advantageous. Proficiency in Microsoft Office applications. Core Competencies Proficiency in English, both spoken and written. Strong problem-solving and analytical thinking. Excellent attention to detail and commitment to quality. Ability to interpret complex protocols, randomization requirements, and supply strategies. Excellent communication, documentation, and stakeholder management skills. Strong team collaboration and the ability to work effectively across technical, clinical, supply chain, and project management functions. Ability to manage multiple studies, priorities, and timelines. Key Responsibilities Lead or support the design, configuration, implementation, and maintenance of RTSM solutions for clinical studies. Translate clinical protocols, randomization schedules, treatment arms, cohorts, visit schedules, and supply requirements into detailed RTSM system specifications. Configure and support randomization algorithms, stratification factors, treatment allocation rules, cohort management, and enrolment controls. Configure investigational product supply functionality, including depot and site inventory, shipment triggers, resupply rules, dispensing, returns, reconciliation, and destruction workflows. Support blinded and unblinded study processes and ensure that access controls protect study blinding. Configure and test emergency unblinding functionality and associated notifications and audit trails. Collaborate with clinical supply, biostatistics, data management, project management, clinical operations, and sponsor teams to ensure that RTSM functionality meets study requirements. Review and support the implementation of randomization lists and treatment allocation schedules in collaboration with authorised statistical and unblinded teams. Develop and review RTSM requirements, configuration specifications, test scripts, traceability documentation, and user guidance. Lead or support user acceptance testing, system validation, regression testing, and go-live readiness activities. Investigate and resolve RTSM incidents, user queries, supply discrepancies, randomization issues, integration failures, and other system-related problems. Manage RTSM amendments and change requests while assessing potential impacts on enrolled subjects, treatment allocation, blinding, and investigational product supply. Support RTSM integrations with EDC platforms, clinical supply systems, CTMS, eCOA, laboratories, depots, and other third-party systems. Support user access management and ensure appropriate separation between blinded and unblinded roles. Monitor RTSM system performance, enrolment activity, inventory levels, shipment status, and study-specific supply risks. Support study closeout activities, including final inventory reconciliation, data transfers, access removal, and system archival. Lead or support the design and implementation of clinical databases in EDC systems, including the programming of automated and manual data validation checks. Manage and implement customer change requests for existing EDC and RTSM study builds. Troubleshoot EDC and clinical system issues and contribute to continuous improvement initiatives. Support or lead system integrations, custom reporting, and advanced EDC module configurations. Assist with analytical reporting configurations for study teams and sponsors. Collaborate with Configuration Specialists to align system builds with company, sponsor, and study standards. Provide program-level technical support and represent the clinical systems design team during sponsor and client meetings. Participate in or lead data validation activities before and after system go-live. Conduct hands-on clinical and external data review or reconciliation when required. Contribute to internal guidance documents, controlled documentation, and process improvement initiatives. Support the development and review of departmental standard operating procedures and work instructions. Mentor, supervise, and train junior team members and peers in RTSM, EDC, and clinical systems design practices. Apply Now! Ready to help design the systems that drive clinical trials, from patient randomization through investigational product supply and clinical data collection? Send your CV to the Bioforum team today. We’re looking for an experienced, quality-driven RTSM specialist who is ready to make a meaningful contribution to the future of clinical trial technology.