Tejas Parve

Clinical Data Manager (2+ years experience) Tata Consultancy Services, Mumbai | March 2023 – Present As a Junior Clinical Data Manager, I manage and support clinical data activities across the study lifecycle—from study start-up through database lock—for Phase III trials in oncology, respiratory, and metabolic indications. My responsibilities include: eCRF & DVS Testing: Conducting user acceptance testing (UAT), amendment validations, and end-to-end data validation checks for study builds. Query & Discrepancy Management: Generating, resolving, and tracking queries to ensure data integrity and compliance with protocol and ICH-GCP guidelines. Vendor Reconciliation: Leading reconciliation of third-party data (SAE, IRT, central/local lab, CBO, sample, and patient trackers) to maintain consistency across datasets. Data Review & Listings: Reviewing manual and programmed data listings and Data Review Plans (DRPs) to ensure clinical relevance and accuracy. Documentation & Compliance: Familiar with key study documents including DMP, eCCG, CRF, test migration and protocol amendment documents. Therapeutic Areas: Hands-on experience in oncology (Mantle Cell Lymphoma, Acute Myeloid Leukemia), respiratory (Bronchial Asthma), and metabolic conditions (Obesity, Cardiac Arrest, Kidney Failure). Collaboration & Training: Engaging with project managers and cross-functional teams while mentoring junior team members and supporting team training initiatives. Tools & Skills: Medidata Rave, InForm, CDISC standards, MS Office Suite, ICH-GCP compliance, Strong interpersonal and time-management skills.