Senior Data Manager

As the Lead Data Manager, your role involves overseeing end-to-end clinical data management activities for multiple trials to ensure data integrity, protocol compliance, and timely database deliverables. You will provide technical leadership, manage data systems and processes, and collaborate with study teams throughout the study lifecycle. Key Responsibilities: - Execute and oversee data management activities for multiple clinical trials, ensuring accuracy and alignment with protocols and EDC systems. - Apply advanced understanding of clinical development, CDISC standards (CDASH, SDTM), technical platforms, confidentiality protocols, and project management principles. - Contribute to trial document development and participate in study team meetings for operational planning and execution. - Serve as the primary point of contact for trial-related data management discussions. - Design mock CRFs, build/update study databases, prepare data transmission agreements, maintain study environments in EDC systems, and develop CRF completion guidelines. - Create Data Management Plans, DVPs, validation rules, manage queries, oversee SAE and vendor reconciliations, and contribute to CQM activities. - Support the development and execution of data listings to ensure completeness, consistency, and quality. - Establish and test SDTM specifications, oversee transformation runs, generate data snapshots, and produce define.XML files with programming teams. - Deliver interim and final datasets, manage post-database lock activities, and maintain/upload trial documentation in the TMF. - Proactively identify project risks, escalate to Project Lead, and perform QC of end-to-end data collection processes. - Track deliverables, ensure zero unresolved queries before database lock, support metrics reporting, and train, mentor, and support new team members on processes and documentation. - Ensure team compliance with SOPs, training documentation requirements, and regulatory expectations. - Provide technical expertise to maintain trial stability, support evolving systems, and lead internal training for Data Management teams on tools and processes. - Complete assigned LOS training on schedule and perform additional tasks as assigned. Experience Required: - Proven experience leading clinical studies, particularly in Study Conduct & Close-Out phases. This job also requires you to be based in Mumbai or Pune, work in a general shift, and fall under the Band BPO 4/5/6. The salary range for this position is 1120 LPA.,