Swaroop Reddy Narala
Sr Clinical Data Manager @精鼎医药
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WORK HISTORY
Sr Clinical Data Manager @精鼎医药
CA
Act as the primary point of contact for clients on all data management deliverables across assigned studies or programs. • Lead and manage multiple global studies or integrated programs, ensuring all milestones are met with a focus on quality, compliance, and timelines. • Negotiate and collaborate directly with customers on timelines, budgets, and resourcing, fostering long-term strategic partnerships. • Provide leadership, mentorship, and training to junior data managers and study teams, promoting professional growth and consistency in deliverables. • Oversee end-to-end data management activities, including CRF/eCRF design, database build, data validation, discrepancy management, and database lock. • Ensure regulatory compliance with ICH-GCP, CDISC/CDASH, 21 CFR Part 11, and company SOPs. • Coordinate closely with Biostatistics, Clinical Operations, Medical Writing, and Project Management to ensure data flow and study progress are aligned. • Develop and maintain Data Management Plans (DMPs), Edit Check Specifications, eCRF Completion Guidelines, and other critical documentation. • Oversee SAE reconciliation, external data import, and lab/vendor data validation to ensure data consistency across all sources. • Lead database UAT activities, ensuring systems are validated and production-ready before go-live. • Contribute to risk assessment and mitigation planning to proactively manage study challenges and ensure data integrity. • Participate in bid defines meetings, client presentations, and proposal reviews as a subject matter expert in Data Management. • Provide metrics and performance tracking to senior management to monitor project health, timelines, and resource utilization. • Ensure audit readiness and participate in internal and external audits/inspections, providing required documentation and data traceability. • Collaborate with technical teams to ensure EDC enhancements, data integration, and system upgrades meet business needs.
EDUCATION
Raghavendra Institute of Pharmaceutical Education & Research, Anantapur
Doctor of Pharmacy - PharmD
ABOUT SWAROOP REDDY NARALA
Experienced Clinical Data Management Professional with 7 years of hands-on experience managing end-to-end data operations across global Phase I–IV clinical trials. Proficient in Electronic Data Capture systems (Medidata RAVE, Inform), CRF and database design, query management, SAE reconciliation, and vendor coordination. Skilled in handling Oncology, CNS, and Cardiology studies, with strong knowledge of CDISC/CDASH standards, ICH-GCP, and FDA regulations. Experienced in medical coding using MedDRA and WHO Drug, ensuring accuracy and regulatory compliance. Known for effective project leadership, cross-functional collaboration, and the ability to deliver high-quality, submission-ready data within timelines while mentoring junior team members.
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