Vaibhav Dalvi

About Vaibhav Dalvi

Clinical Data Analyst I at Parexel with hands-on experience managing end-to-end clinical data — from study startup to database lock — across Phase I to Phase IV trials. I bring a strong command of ICH-GCP guidelines and a passion for delivering clean, compliant, and submission-ready data. My experience spans therapeutic areas like Oncology and Respiratory Disorders, working with industry-standard EDC systems including Oracle InForm and Medidata Rave. Startup Phase: Proficient in DVS creation, CRF completion guideline development, offline listing specification, UAT of MM/PPL/DM/PD listings, and testing dynamics, conditions, and email alerts. Conduct Phase: Skilled in query management, SAE reconciliation, lesion cleaning (RECIST 1.1), third-party vendor data reconciliation (Biomarkers, PK, Imaging, ECG), protocol deviation tracking, metrics preparation, and ongoing data reviews. Close-Out Phase: Experience in database freezing, study locking, and document archival using Veeva Vault. Additionally, I have foundational knowledge of SAS and SQL, supporting better understanding of raw datasets and contributing to clean data review. Certified in Clinical Data Management (CCDA), I am dedicated to upholding data integrity, ensuring compliance, and contributing to the success of high-quality clinical trials.

Experience

1. Clinical Data Analyst i

   Parexel

   Nov 2024 — Present · Mumbai, IN

   Performing end-to-end data management activities across Phase I–IV clinical trials, primarily in Oncology and Respiratory therapeutic areasWorking on EDC platform Medidata Rave for data review, discrepancy management, and eCRF reviewExecuting creation and testing of data validation specification ( dynamics, conditions, derivations and mapping, edit checks, system checks, email alerts ) and offline listings specifications (MM, PD, DM, PPL).Participating in database freezing and study lock activities, along with document archiving in Veeva VaultSupporting data quality through query resolution, metrics tracking, and cross-functional communicationThis role is allowing me to apply my CDM skills in a fast-paced global CRO environment while deepening my technical expertise and therapeutic area knowledge.

Education

• C.S.Kothari High School Nandura Dist. Buldhana

  SSC - 91.00%

  2014 — 2015

• Prof.Prakash Dawale Junior College,Akola

  HSC - 73.23%

  2016 — 2017

• Anuradha College of Pharmacy, Chikhali.

  Bachelor of Pharmacy

  2018 — 2022