Senior Clinical Data Systems Designer - RTSM Specialist (India)

Job Summary

Required 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
• 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
• 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
• 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