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@kiranyadav
Clinical research professional with 7+ years' experience in CTA, site and regulatory management.
I am a dedicated clinical research professional with over seven years of progressive experience as a Clinical Trial Assistant, working across pharmaceutical and medical device studies. I have supported full study lifecycles from start-up to close-out, handled regulatory submissions, maintained trial master files, and ensured audit readiness.
My background includes site management, co-monitoring, informed consent customization, safety reporting and SAE management, and financial operations such as purchase order and invoice processing. I have hands-on experience with eCRF/eTrack systems, Veeva Vault, and calibration of lab equipment to support study integrity.
I have contributed to therapeutic-area studies including cardiovascular devices (First-in-Human MyVal-1), orthopedics, infectious disease, ophthalmology and gastroenterology, and earned recognition such as the IQVIA Spotlight Award. I seek to apply my dual-industry expertise to deliver compliant, high-quality clinical trial outcomes.
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Work history, roles, and key accomplishments
Managed regulatory and trial documentation, vendor invoices/POs, and study trackers across full study lifecycles, ensuring audit readiness and supporting site management and patient follow-up for timely protocol adherence.
Served as POC for SMBS process and regulatory updates, maintained eTrack compliance, conducted investigator feasibility/debarment checks, and prepared periodic reports for global stakeholders.
Meril Life Sciences
Apr 2018 - Feb 2021 (2 years 10 months)
Supported study start-up, EC submissions, site coordination and TMF maintenance; performed co-monitoring, SIVs, close-outs, safety reporting, payment tracking, and assisted CRAs/PMs including temporary CRA coverage.
Degrees, certifications, and relevant coursework
Post Graduate Diploma in Clinical Research, Clinical Research
2017 - 2018
Completed a Post Graduate Diploma in Clinical Research, covering regulatory submissions, clinical trial operations, and safety documentation.
Bachelor of Science, Biotechnology
2015 - 2017
Bachelor of Science in Biotechnology with coursework in biological sciences and laboratory techniques.
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