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Deepthi D

Clinical Data Management | Full-cycle clinical data delivery |AI-Driven Data Review & Validation | Multi-vendor reconciliation | Audit-ready documentation | Cross-functional collaboration | Clinical Data Associate

Bengaluru

2+ years of work experience

Sitero
Apr 20263 mosPresent

Bengaluru

• Perform clinical data review and discrepancy management for global Phase II-IV clinical studies, ensuring data quality and submission readiness. • Execute reconciliation activities across EDC and external vendor datasets including eCOA, PK, IVRS/IWRS, laboratory, and device data. • Investigate data inconsistencies, perform root-cause analysis, and collaborate with vendors and study teams to drive timely resolution. • Maintain study trackers, reconciliation specifications, and audit-ready documentation supporting inspection readiness. • Support database lock activities by ensuring completion of critical data review and reconciliation milestones. • Collaborate with Clinical Operations, and external vendors to ensure on-time study deliverables.
Sitero
Nov 20241 yr 6 mosApr 2026

Mysore

• Perform end-to-end data handling, cleaning, and discrepancy management across study phases, ensuring FDA submission compliance. • Lead query management, vendor data reconciliations (e.g., cough monitor, PK, eCOA, IVRS, MRL), and QC reviews to deliver submission-ready, inspection-compliant datasets. • Develop and validate SAS outputs based on CDRP; support reprogramming and deployment of reconciliation tools. • Maintain study trackers (e.g., Clean Patient Tracker), generate operational reports, and perform image redaction to uphold data privacy and regulatory standards. • Collaborate cross-functionally with SAS Programmers, data managers, statisticians, and clinical operations to drive accuracy, efficiency, and workflow optimization
Karnataka Antibiotics Pharmaceutical Ltd
Jun 20232 mosJul 2023

Bengaluru, Karnataka, India

1. Training in diverse pharmaceutical formulations. 2. Adept in aseptic Small Volume Parenteral production. 3. Skilled in pharmaceutical inventory and compliance. 4. Experienced in maintaining industry-standard quality control.
Aug 20205 mosDec 2020

Answering phones and explaining the product and services offered by the company. Contacting existing customers as well as prospective customers using scripts. Obtaining customer information and other relevant data Asking questions to the customer and understanding their specifications. Resolving queries and issues related to the services.

Education

Dayananda Sagar University

Bachelor of Pharmacy, Pharmaceutical Sciences

Dayananda Sagar University

20204 yrs2024

Pre-university Education, Science

Vidyodaya Pre University College

20182 yrs2020

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Headline

Clinical Data Management | Full-cycle clinical data delivery |AI-Driven Data Review & Validation | Multi-vendor reconciliation | Audit-ready documentation | Cross-functional collaboration | Clinical Data Associate

About

Clinical Data Management professional with hands-on experience supporting global Phase II-IV clinical studies across the full data review lifecycle. Experienced in clinical data review, discrepancy management, vendor data reconciliation, and database lock support, ensuring delivery of submission-ready datasets in compliance with ICH-GCP, FDA, and study-specific requirements. Currently supporting cross-functional study teams by reviewing and reconciling data from EDC and external vendor sources including eCOA, PK, IVRS/IWRS, device, and laboratory data. Skilled in identifying data trends, resolving complex discrepancies, maintaining audit-ready documentation, and driving timely issue resolution with internal stakeholders and external vendors. Strong foundation in clinical trial operations, quality-focused execution, and continuous process improvement with working knowledge of Power BI, Excel, and AI-assisted data review approaches.

Location

Bengaluru

Work experience

Clinical Data Associate I at Sitero, Apr 2026 - Present · 3 mos, Bengaluru, • Perform clinical data review and discrepancy management for global Phase II-IV clinical studies, ensuring data quality and submission readiness. • Execute reconciliation activities across EDC and external vendor datasets including eCOA, PK, IVRS/IWRS, laboratory, and device data. • Investigate data inconsistencies, perform root-cause analysis, and collaborate with vendors and study teams to drive timely resolution. • Maintain study trackers, reconciliation specifications, and audit-ready documentation supporting inspection readiness. • Support database lock activities by ensuring completion of critical data review and reconciliation milestones. • Collaborate with Clinical Operations, and external vendors to ensure on-time study deliverables.

Junior Clinical Data Associate at Sitero, Nov 2024 - Apr 2026 · 1 yr 6 mos, Mysore, • Perform end-to-end data handling, cleaning, and discrepancy management across study phases, ensuring FDA submission compliance. • Lead query management, vendor data reconciliations (e.g., cough monitor, PK, eCOA, IVRS, MRL), and QC reviews to deliver submission-ready, inspection-compliant datasets. • Develop and validate SAS outputs based on CDRP; support reprogramming and deployment of reconciliation tools. • Maintain study trackers (e.g., Clean Patient Tracker), generate operational reports, and perform image redaction to uphold data privacy and regulatory standards. • Collaborate cross-functionally with SAS Programmers, data managers, statisticians, and clinical operations to drive accuracy, efficiency, and workflow optimization

Internship Trainee at Karnataka Antibiotics Pharmaceutical Ltd, Jun 2023 - Jul 2023 · 2 mos, Bengaluru, Karnataka, India, 1. Training in diverse pharmaceutical formulations. 2. Adept in aseptic Small Volume Parenteral production. 3. Skilled in pharmaceutical inventory and compliance. 4. Experienced in maintaining industry-standard quality control.

Tele calling and Costumer Support at Spandana, Aug 2020 - Dec 2020 · 5 mos, Answering phones and explaining the product and services offered by the company. Contacting existing customers as well as prospective customers using scripts. Obtaining customer information and other relevant data Asking questions to the customer and understanding their specifications. Resolving queries and issues related to the services.

Education

Bachelor of Pharmacy, Pharmaceutical Sciences, Dayananda Sagar University

Pre-university Education, Science, Vidyodaya Pre University College