Gauri Pitale
LABORATORY PROJECT STUDY STARTUP - CLINICAL DATA MANAGEMENT
- Role
- Lab Project Study Startup at IQVIA
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Gauri Pitale
Highly results-oriented Clinical Data Management (CDM) professional with 6+ years of…
Experience
Lab Project Study Startup
Oct 2023 — Present · Mumbai, IN
Actively participated in study kick-off meetings, design calls, and internal/sponsor meetings for assigned clinical studies, contributing to initial planning and ongoing strategy.• Collaborated closely with various stakeholders, including clinical research associates, site staff, biostatisticians, and study teams, to clarify data points and ensure smooth data flow.• Successfully loaded diverse databases (e.g, Complexity A, B, C, D) into clinical trial databases, consistently maintaining data integrity and accuracy.• Efficiently managed and implemented Database Change Requests (DCRs) and Service Verification Checks (SCVC), ensuring timely resolution and strict adherence to study protocols.• Configured project databases as required, optimizing data flow and management for specific study needs.• Contributed to study close-out activities, including database lock and meticulous archiving of study documents.• Performed all data management functions, from study startup and data cleaning to database lock. Managed issue resolution, database loading, and tracker updates.
Education
Mumbai University Mumbai
Bachelor of Science - BS
2012 — 2015
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