Abhijeet Mhatre

Sr Clinical Data Associate @Syneos Health

Mumbai, IN

Project Scope & Compliance: Ensure adherence to contract scope and study-specific Data Management Plans (DMP), providing regular status updates to Project and Biometrics Managers.User Acceptance Testing (UAT): Develop test data and execute UAT for clinical database screens, edit checks, role configurations, and Targeted Source Data Verification (SDV).Clinical Data Entry & Management: Enter and validate lab normal ranges, manage Clinical Database Management System (CDMS) access, and oversee data entry processes.Data Review & Query Resolution: Conduct discrepancy reviews, resolve edit checks, apply self-evident corrections, and manage query resolution per Data Validation Specifications (DVS).Paper & Electronic Data Capture (EDC) Management: Process Data Clarification Forms (DCFs), conduct internal quality control (QC) checks, and ensure accurate documentation of CRFs and DCFs.Audit & Compliance Support: Participate in internal/external audits, in-process reviews, and customer meetings while ensuring regulatory compliance.External Data Reconciliation: Verify consistency between clinical database and external datasets (lab data, electronic diaries, PK data, IRT systems), documenting discrepancies and coordinating resolutions.Process Optimization & Reporting: Generate and analyze data cleaning/status reports, perform SAE reconciliations, and provide study metrics for process improvement.Database Design & Specifications: Review database configurations, annotated CRFs, and edit check specifications while collaborating with Clinical Programming and Biostatistics teams.Stakeholder Collaboration & Training: Liaise with cross-functional teams, mentor junior Data Managers, and contribute to knowledge-sharing sessions.Data Transfer & Documentation: Prepare Data Transfer Request Forms, maintain Data Management Study Files (DMSF), and ensure timely delivery of study-specific documents.

Institute of clinical Research India

Post graduation diploma in Clinical Research (ICRI), Clinical Research

University of Mumbai

Bachelor's degree, Chemistry

Gypsy divers

Advance open water certification, scuba diving