Srujan
Senior Clinical Data Associate @Syneos Health Clinical Solutions
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WORK HISTORY
Senior Clinical Data Associate @Syneos Health Clinical Solutions
Hyderabad, IN
Lead data management activities, including Data Review Plan listings and query management for multiple studies.• Manage weekly team assignments, ensuring resource optimization and timeline adherence.• Organise vendor and SAE reconciliation, maintaining data consistency across databases.• Generate and analyze SQL reports, including biweekly Data Review Plans and discrepancy reports.• Maintain Clean Patient Tracker with weekly interim analysis monitoring SDV/SDR status and data completeness.• Handle eTMF documentation workflow with timely document uploads and monthly submissions.• Coordinate cross-functional teams through monthly study meetings and weekly internal calls.• Execute biweekly SAS listings reviews, maintaining high data quality standards.• Managing External Data Acquisition (EDA) processes, integrating laboratory, central imaging, ECG, and other external vendor data into clinical databases.• Ensuring data quality and reconciliation accuracy for external data sources while maintaining compliance with study protocol requirements.• Mentor team members on complex data management challenges and best practices.
EDUCATION
Chalapathi
SSC
Avigna Clinical Research Institute
Postgraduate Diploma, Clinical Data Management
Samskruthi GNITS
Master of Pharmacy, Pharmacology
Avigna Clinical Research Institute
PG Diploma in Clinical Data Management (PGDCDM)
Samskruthi College of Pharmacy, JNTU Hyderabad, Telangana
M.Pharmacy, Pharmacology
Jawaharlal Nehru Technological University
Bachelor of Pharmacy - BPharm
ABOUT SRUJAN
Dynamic and results-driven Senior Clinical Data Associate with 11+ years of progressive expertise in Clinical Data Management across pharmaceutical and CRO environments.• Managed end-to-end clinical data activities from study conduct through closeout across Oncology, Dermatology, Vaccines, and COVID-19.• Led team mentoring, cross-functional coordination with clinical operations, database programming, vendors, and monitors.• Demonstrated proficiency with multiple EDC systems (Veeva Vault, Inform, Rave, Oracle Clinical) with strong ICH-GCP and 21 CFR Part 11 compliance knowledge.• Managed data reconciliation, query management, User Acceptance Testing, and external data acquisition with a quality focus.
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