Amar Vhadade
Sr. Clinical Data Associate at TCS Clinical Data Management Specialist | Global Clinical Trials | EDC Systems | Data Integrity & Compliance | Argus Safety & Veeva UAT Expert
- Role
- Sr Clinical Data Associate at Tata Consultancy Services
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Amar Vhadade
Experienced Clinical Data Management Specialist with 5+ years in global clinical trials, skilled in EDCsystems, query resolution, vendor data reconciliation (SAE, RAMOS, PK), protocol deviation review, anddatabase lock/freezing. Proven expertise in Argus Safety UAT and Veeva Studies UAT using ALMsoftware, ensuring compliance, data integrity, and audit readiness. Strong track record in study set‑ up,conduct, and close‑ out activities, delivering high‑ quality outputs through cross- functional collaborationand adherence to GCP/SOP standards.
Experience
Sr Clinical Data Associate
Jan 2023 — Present · Mumbai, IN
Key Responsibilities: Led daily Query Management Reporting (QMR), allocating tasks across the team and ensuringtimely query resolution in EDC systems, which improved overall data quality and compliance. Issued and tracked database queries for missing, inconsistent, illegible, or erroneous data; droveresolution and close-out to maintain 100% audit readiness. Performed Veeva Studies User Acceptance Testing (UAT) using ALM (Application LifecycleManagement) software, ensuring system functionality, compliance, and data integrity acrossclinical studies. Reviewed and validated IQD queries, proactively identifying discrepancies and escalatingunresolved issues to the Study Data Manager (SDM). Participated in Argus Safety Database Upgradation UAT, validating process workflows andensuring seamless transition to upgraded system. Managed Local Lab Normal Ranges (LNR) data entry, performed QC checks, and archiveddocuments in compliance with SOPs and regulatory standards. Prepared weekly/monthly LNR reports and coordinated with CRAs to resolve missing ranges,reducing turnaround time for lab data reconciliation.
Education
Bhavans College
High School Diploma, Science
2013 — 2015
University of Mumbai
Master of Science - MS, Chemistry
Clinomic Center for Clinical Research Pvt. Ltd.
Post Graduate Diploma in Clinical Research, Clinical Research
2019 — 2020
Bhavans College
Bachelor of Science, Chemistry
2015 — 2019
Indian Education Society Secondary School Marol, Powai
SSC, Marathi
2008 — 2013
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