Amar Vhadade
Sr. Clinical Data Associate
About me
Sr. Clinical Data Associate at TCS | Clinical Data Management Specialist | Global Clinical Trials | EDC Systems | Data Integrity & Compliance | Argus Safety & Veeva UAT Expert
Experienced Clinical Data Management Specialist with 5+ years in global clinical trials, skilled in EDC systems, query resolution, vendor data reconciliation (SAE, RAMOS, PK), protocol deviation review, and database lock/freezing. Proven expertise in Argus Safety UAT and Veeva Studies UAT using ALM software, 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 collaboration and adherence to GCP/SOP standards.
Skills
Work Experience
Sr. Clinical Data Associate
Tata Consultancy Services
2023-01-02
-
Present
Led daily QMR activities, assigning tasks and ensuring timely query resolution in EDC systems to improve data quality and compliance.
Raised and tracked queries for missing or inconsistent data, ensuring prompt resolution and audit readiness.
Conducted Veeva Studies UAT using ALM, validating system functionality, compliance, and data integrity.
Reviewed IQD queries, identified discrepancies, and escalated unresolved issues to the SDM.
Supported Argus Safety UAT during database upgrades, ensuring smooth workflow transitions.
Managed LNR data entry, QC, reporting, and coordination with CRAs to streamline lab data reconciliation.
Executive
Clearsynth
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* Maintained site communication and trackers, following up on discrepancies and ensuring timely updates from CRAs.
* Prepared study metrics reports, providing insights into data management performance.
* Supported study setup activities including database design, CRF development, and SOP compliance.
* Ensured documentation aligned with GCP/SOP and created MOMs for clear communication.
* Managed AE/SAE reconciliation and oversaw study conduct and closeout with zero major audit findings.
Unilever
Research And Development Coordinator
2019-12-01
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2020-10-08
Monitored study progress and ensured data quality by identifying and resolving issues promptly.
Collected, analyzed, and reported data in line with protocols and industry standards.
Trained study sites and personnel on protocols and procedures.
Contributed to CRF design, data tools, study materials, and protocol development per FDA and GCP guidelines.
Trainee
Health Prime
2019-08-01
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2019-12-12
Maintained strict client confidentiality and ensured compliance with HIPAA regulations for all information requests.
Managed and retrieved medical records efficiently using both physical and electronic systems.
Education
Master of Science - MSc- Chemistry
Masters
2019-04-01
-
2021-04-01
University of Mumbai
Grade A
Activities and societies: Laboratory protocols and safety practices
Dedicated to driving scientific research, innovation, and contributing to the advancement of chemical knowledge and industry solutions.
Bachelor of Science, Chemistry
Bachelors
2015-04-01
-
2019-04-29
Bhavans College
Grade: B
Activities and societies: Scientific research, innovation, demonstrating lab procedures
Dedicated to driving scientific research, innovation, and contributing to the advancement of chemical knowledge and industry solutions.
Painpoints
Pls tick the issues faced in the previous interviews.
Lengthy process
Open-To-Work
Are You Open To Work?
Definitely yes