Senior Clinical Data Systems Designer - RTSM Specialist (India)

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    "description": "<p><span style=\"font-size: 10pt; font-weight: bold\">Technical Designer / Database Architect</span></p>\n<p><br></p>\n<p><span style=\"font-size: 10pt\">We’re on the lookout for a <span style=\"font-weight: bold\">Senior Clinical Data Systems Designer with specialist expertise in Randomization and Trial Supply Management (RTSM)</span> to join our dynamic, growing team.</span></p>\n<p><span style=\"font-size: 10pt\">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.</span></p>\n<p><span style=\"font-size: 10pt\">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.</span></p>\n<p><br></p>\n<p><span style=\"font-size: 10pt; font-weight: bold\">Why Bioforum?</span></p>\n<p><span style=\"font-size: 10pt\">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.</span></p>\n<p><br></p>\n<p><span style=\"font-size: 10pt; font-weight: bold\">Minimum Qualifications</span></p>\n<ul>\n<li><span style=\"font-size: 10pt\">Bachelor’s degree or higher in biomedical sciences, life sciences, information technology, or a related discipline, or equivalent relevant experience.</span></li>\n<li><span style=\"font-size: 10pt\">Relevant training, certification, or demonstrated experience in an RTSM, IRT, or IWRS platform.</span></li>\n<li><span style=\"font-size: 10pt\">Certification in Medidata Rave, RaveX, Veeva EDC, or another recognized EDC platform is highly desirable.</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"font-size: 10pt; font-weight: bold\">Minimum Experience</span></p>\n<ul>\n<li><span style=\"font-size: 10pt\">2 to 4 years of experience in a technical designer, database architect, RTSM specialist, or similar clinical systems role.</span></li>\n<li><span style=\"font-size: 10pt\">Practical experience designing, configuring, testing, implementing, or supporting RTSM solutions.</span></li>\n<li><span style=\"font-size: 10pt\">Experience supporting clinical studies from system design through go-live, maintenance, and study closeout.</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"font-size: 10pt; font-weight: bold\">Key Skills</span></p>\n<ul>\n<li><span style=\"font-size: 10pt\">Strong understanding of RTSM, IRT, and IWRS processes within clinical trials.</span></li>\n<li><span style=\"font-size: 10pt\">Knowledge of randomization methodologies, including simple, block, stratified, and cohort-based randomization.</span></li>\n<li><span style=\"font-size: 10pt\">Understanding of investigational product supply processes, including forecasting, packaging, labelling, inventory management, shipment, dispensing, returns, reconciliation, and destruction.</span></li>\n<li><span style=\"font-size: 10pt\">Experience translating protocols and sponsor requirements into RTSM and EDC system specifications.</span></li>\n<li><span style=\"font-size: 10pt\">Strong understanding of clinical trial workflows, data standards, study blinding, and controlled unblinding processes.</span></li>\n<li><span style=\"font-size: 10pt\">Proficiency in one or more RTSM platforms, such as Medidata RTSM, Suvoda, 4G Clinical, Signant Health, Almac, or another recognized RTSM solution.</span></li>\n<li><span style=\"font-size: 10pt\">Proficiency in one or more EDC platforms, such as Medidata Rave, RaveX, Veeva EDC, or an equivalent clinical data platform.</span></li>\n<li><span style=\"font-size: 10pt\">Familiarity with system integrations between RTSM, EDC, CTMS, eCOA, central laboratories, depots, and other clinical systems.</span></li>\n<li><span style=\"font-size: 10pt\">Familiarity with programming or scripting languages such as SQL, VBA, C#, or similar technologies is advantageous.</span></li>\n<li><span style=\"font-size: 10pt\">Proficiency in Microsoft Office applications.</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"font-size: 10pt; font-weight: bold\">Core Competencies</span></p>\n<ul>\n<li><span style=\"font-size: 10pt\">Proficiency in English, both spoken and written.</span></li>\n<li><span style=\"font-size: 10pt\">Strong problem-solving and analytical thinking.</span></li>\n<li><span style=\"font-size: 10pt\">Excellent attention to detail and commitment to quality.</span></li>\n<li><span style=\"font-size: 10pt\">Ability to interpret complex protocols, randomization requirements, and supply strategies.</span></li>\n<li><span style=\"font-size: 10pt\">Excellent communication, documentation, and stakeholder management skills.</span></li>\n<li><span style=\"font-size: 10pt\">Strong team collaboration and the ability to work effectively across technical, clinical, supply chain, and project management functions.</span></li>\n<li><span style=\"font-size: 10pt\">Ability to manage multiple studies, priorities, and timelines.</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"font-size: 10pt; font-weight: bold\">Key Responsibilities</span></p>\n<ul>\n<li><span style=\"font-size: 10pt\">Lead or support the design, configuration, implementation, and maintenance of RTSM solutions for clinical studies.</span></li>\n<li><span style=\"font-size: 10pt\">Translate clinical protocols, randomization schedules, treatment arms, cohorts, visit schedules, and supply requirements into detailed RTSM system specifications.</span></li>\n<li><span style=\"font-size: 10pt\">Configure and support randomization algorithms, stratification factors, treatment allocation rules, cohort management, and enrolment controls.</span></li>\n<li><span style=\"font-size: 10pt\">Configure investigational product supply functionality, including depot and site inventory, shipment triggers, resupply rules, dispensing, returns, reconciliation, and destruction workflows.</span></li>\n<li><span style=\"font-size: 10pt\">Support blinded and unblinded study processes and ensure that access controls protect study blinding.</span></li>\n<li><span style=\"font-size: 10pt\">Configure and test emergency unblinding functionality and associated notifications and audit trails.</span></li>\n<li><span style=\"font-size: 10pt\">Collaborate with clinical supply, biostatistics, data management, project management, clinical operations, and sponsor teams to ensure that RTSM functionality meets study requirements.</span></li>\n<li><span style=\"font-size: 10pt\">Review and support the implementation of randomization lists and treatment allocation schedules in collaboration with authorised statistical and unblinded teams.</span></li>\n<li><span style=\"font-size: 10pt\">Develop and review RTSM requirements, configuration specifications, test scripts, traceability documentation, and user guidance.</span></li>\n<li><span style=\"font-size: 10pt\">Lead or support user acceptance testing, system validation, regression testing, and go-live readiness activities.</span></li>\n<li><span style=\"font-size: 10pt\">Investigate and resolve RTSM incidents, user queries, supply discrepancies, randomization issues, integration failures, and other system-related problems.</span></li>\n<li><span style=\"font-size: 10pt\">Manage RTSM amendments and change requests while assessing potential impacts on enrolled subjects, treatment allocation, blinding, and investigational product supply.</span></li>\n<li><span style=\"font-size: 10pt\">Support RTSM integrations with EDC platforms, clinical supply systems, CTMS, eCOA, laboratories, depots, and other third-party systems.</span></li>\n<li><span style=\"font-size: 10pt\">Support user access management and ensure appropriate separation between blinded and unblinded roles.</span></li>\n<li><span style=\"font-size: 10pt\">Monitor RTSM system performance, enrolment activity, inventory levels, shipment status, and study-specific supply risks.</span></li>\n<li><span style=\"font-size: 10pt\">Support study closeout activities, including final inventory reconciliation, data transfers, access removal, and system archival.</span></li>\n<li><span style=\"font-size: 10pt\">Lead or support the design and implementation of clinical databases in EDC systems, including the programming of automated and manual data validation checks.</span></li>\n<li><span style=\"font-size: 10pt\">Manage and implement customer change requests for existing EDC and RTSM study builds.</span></li>\n<li><span style=\"font-size: 10pt\">Troubleshoot EDC and clinical system issues and contribute to continuous improvement initiatives.</span></li>\n<li><span style=\"font-size: 10pt\">Support or lead system integrations, custom reporting, and advanced EDC module configurations.</span></li>\n<li><span style=\"font-size: 10pt\">Assist with analytical reporting configurations for study teams and sponsors.</span></li>\n<li><span style=\"font-size: 10pt\">Collaborate with Configuration Specialists to align system builds with company, sponsor, and study standards.</span></li>\n<li><span style=\"font-size: 10pt\">Provide program-level technical support and represent the clinical systems design team during sponsor and client meetings.</span></li>\n<li><span style=\"font-size: 10pt\">Participate in or lead data validation activities before and after system go-live.</span></li>\n<li><span style=\"font-size: 10pt\">Conduct hands-on clinical and external data review or reconciliation when required.</span></li>\n<li><span style=\"font-size: 10pt\">Contribute to internal guidance documents, controlled documentation, and process improvement initiatives.</span></li>\n<li><span style=\"font-size: 10pt\">Support the development and review of departmental standard operating procedures and work instructions.</span></li>\n<li><span style=\"font-size: 10pt\">Mentor, supervise, and train junior team members and peers in RTSM, EDC, and clinical systems design practices.</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"font-size: 10pt; font-weight: bold\">Apply Now!</span></p>\n<p><span style=\"font-size: 10pt\">Ready to help design the systems that drive clinical trials, from patient randomization through investigational product supply and clinical data collection?</span></p>\n<p><span style=\"font-size: 10pt\">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.</span></p>",
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