Headline

Clinical Data Management Associate | GxP, Medidata Rave, Data Integrity (ALCOA+) | Computer System Validation (CSV)

About

Clinical Data Management professional with experience supporting GxP-regulated clinical trials across global studies. Currently working as a Clinical Data Management Associate at Accenture, contributing to clinical data review, discrepancy management, data quality activities, and cross-functional collaboration within the Life Sciences domain. Prior to joining Accenture, I gained hands-on experience at IQVIA, working with Medidata Rave EDC and supporting critical clinical data management processes including data validation, query management, IRT reconciliation, data cleaning, and ensuring audit-ready datasets aligned with ALCOA+ data integrity principles. My experience has strengthened my understanding of clinical trial operations, regulatory expectations, and the importance of maintaining high-quality, reliable clinical data throughout the study lifecycle. Alongside my operational responsibilities, I continue to build expertise in: • Computer System Validation (CSV) • GAMP 5 Methodology • Risk-Based Validation Approaches • 21 CFR Part 11 Compliance • EU Annex 11 Requirements • GxP Compliance & Data Integrity I am particularly interested in the intersection of Clinical Data Management, Life Sciences Technology, Validation, and Regulatory Compliance, with a long-term focus on consulting and technology-enabled quality solutions within regulated environments. Core Competencies: • Clinical Data Management (CDM) • Medidata Rave EDC • Query Management & Data Validation • Clinical Data Review & Cleaning • Data Integrity (ALCOA+) • Computer System Validation (CSV) • GxP Compliance • Regulatory Readiness Always open to connecting with professionals across Clinical Research, Clinical Data Management, CSV, Digital Validation, and Life Sciences Consulting.

Location

Greater Bengaluru Area

AI stack

deepseek

lovable

metaai

openai

ChatGPT

Microsoft Copilot

Work experience

Clinical Data Management Associate at Accenture in India, Aug 2026 - Present · 2 mos, Asia

Associate Clinical Data coordinator at IQVIA Asia Pacific, Jan 2026 - Aug 2026 · 8 mos, Bengaluru

Trainee Clinical Data Coordinator at IQVIA Asia Pacific, Dec 2024 - Jan 2026 · 1 yr 2 mos, Bangalore Urban, During my time at IQVIA so far, I’ve gained hands-on experience in core clinical data management processes and contributed to ongoing study activities. My key responsibilities have included: 🔹 Actioning clinical data queries – Reviewing and resolving discrepancies to ensure data accuracy and completeness. 🔹 IRT Reconciliation – Comparing data between EDC and IRT systems to identify and correct mismatches. 🔹 Missing Lab Review – Identifying and following up on missing lab data to ensure protocol compliance. 🔹 Vendor Issue Log Updates – Tracking and updating issues reported to external vendors to support timely resolution. 🔹 DMT Reviews – Participating in Data Management Team reviews to support study data cleaning and validation activities.

Placement Coordinator at Dayananda Sagar University, Jan 2024 - Aug 2024 · 8 mos, Bengaluru, Karnataka, India

Summer Internship at Kusum Group of Companies, Jul 2023 - Jul 2023 · 1 mo, Rajasthan, India, excited to share that I've successfully completed my journey with Kusum health care (P) LTD. greatful for the incredible learning experience, challenging project an opportunity to collaborate with talented individual throughout this internship. looking forward to applying my newfound knowledge skills to drive growth and innovation in professional world #bioinformatics #pharmaworld #stem #pharmaplant

Campus Ambassador at Verzeo, Mar 2022 - Aug 2022 · 6 mos, India

Education

Bachelor of Pharmacy - BPharm, Final Year Pharma Student, Dayananda Sagar University

Professional Diploma in Clinical Research, CLINICAL RESEARCH, Catalyst Clinical Services