Headline

Clinical Data Specialist | Oncology & Rare Disease

About

Clinical Data Specialist with 7+ years of end-to-end CDM experience across global CROs — delivering audit-ready, GCP-compliant data from study startup through database lock in Oncology and Rare Disease trials (Phase I–III). I architect data management frameworks that work: DMPs that anticipate protocol risk, CRFs designed for clean data capture, and edit check programs that catch discrepancies before they compound. At IQVIA, I proactively flagged discrepancies across oncology trials — preventing protocol deviations from reaching lock. At Atorus, I led concurrent Phase II/III studies while cutting data discrepancy rates and accelerating CDM onboarding. Beyond the data, I build teams. I've mentored junior CDMs, served as primary sponsor-facing contact, and led cross-functional coordination with Biostatistics, Clinical Operations, Pharmacovigilance, and Medical Coding — consistently earning recognition for technical depth and responsiveness. What I bring to the table: Full-cycle CDM across Medidata Rave, Oracle InForm, and Veeva Vault CDMS SAS programming for listings, macros, and reconciliation CDISC/CDASH, SDTM, MedDRA, WHODrug — applied, not just known Regulatory fluency: ICH E6(R2/R3), 21 CFR Part 11, GCP Scientific grounding: M.Pharm + two peer-reviewed pharmacology publications Currently at Fortrea Development India, driving data quality and compliance for oncology and rare disease programmes with zero lock-related audit findings. Open to senior CDM and lead roles in global CROs and pharmaceutical environments.

Location

Mumbai

AI stack

claude

gemini

perplexity

Microsoft Copilot

Work experience

Clinical Data Specialist at Fortrea, Mar 2025 - Present · 1 yr 5 mos, Bengaluru, Karnataka, India, Lead end-to-end data review and validation across Phase II/III oncology and rare disease trials, maintaining 100% adherence to DMPs and sponsor timelines with zero database integrity issues. Drive database lock/unlock procedures — authoring lock checklists, managing closure criteria, and ensuring full ICH E6(R2) and 21 CFR Part 11 compliance — achieving zero lock-related audit findings to date. Generate and QC SAS-based data listings, reconciliation programs, and sponsor-facing reports that meet CDISC/CDASH submission standards. Collaborate cross-functionally with Biostatistics, Clinical Operations, Medical Coding, and Safety teams to streamline database setup, milestone tracking, and data review — eliminating communication bottlenecks across teams. Train and onboard new CDM staff on Medidata Rave and Oracle InForm workflows; maintain eTMF documentation packages for regulatory inspection readiness. Recognised by management for exceeding delivery expectations during a major data migration and cleaning initiative, directly improving downstream reporting accuracy and data quality.

Sr. Clinical data manager at Atorus, Nov 2022 - Dec 2023 · 1 yr 2 mos, Bengaluru, Karnataka, India, Spearheaded full-cycle data management across 4+ concurrent Phase II/III oncology and rare disease trials — from protocol review, study startup, and Medidata Rave database build through to database lock — ensuring on-time, high-quality data delivery across all studies. • • • • • Authored Data Management Plans (DMPs), designed Case Report Forms (CRFs), and developed data validation specifications and edit check programs from protocol and SAP requirements, cutting data discrepancy rates by approximately 30% against baseline. Supervised and mentored a team of 3–4 junior data managers and CDM associates; conducted structured performance reviews and hands-on guidance sessions that measurably improved individual data quality KPIs and accelerated onboarding timelines by 25%. Served as the primary sponsor-facing Data Management point of contact for oncology and rare disease programme leads; led data review meetings, and query escalation discussions — earning consistent positive sponsor feedback on responsiveness and technical depth. Partnered with Biostatistics and Pharmacovigilance teams to resolve critical SAE and PK discrepancies, supporting clean regulatory submissions within aggressive timelines. Managed MedDRA and WHODrug medical coding reviews, reconciliation with safety database, and external data vendor reconciliation for lab and ECG data. ★ KEY CONTRIBUTION: Promoted to primary client contact reflecting technical credibility and communication quality.

Clin data validation specialist at IQVIA, Mar 2021 - Nov 2022 · 1 yr 9 mos, Bengaluru, Karnataka, India, Reviewed and validated clinical oncology datasets against study protocols, edit check specifications, and regulatory standards (ICH E6 R2, 21 CFR Part 11), achieving 100% GCP compliance across all assigned studies with zero critical audit findings. Conducted systematic data quality audits across multiple oncology trials, proactively identifying 150+ discrepancies and escalating risk-ranked issues to senior DM leads — preventing downstream protocol deviations from reaching the database lock stage. Collaborated cross-functionally with CDM, Clinical Operations, and Biostatistics teams to resolve complex data queries within SLA timelines, contributing to on-schedule database lock for 3 Phase III oncology studies. Gained hands-on expertise in SAS-generated data listings, CRF annotation reviews, and reconciliation programming within the Medidata Rave EDC environment. ★ KEY CONTRIBUTION: Promoted to primary client contact within 6 months, reflecting technical credibility and communication quality recognised by senior management and sponsors.

Senior Process Associate at Tata Consultancy Services, Jan 2018 - Jun 2022 · 4 yrs 6 mos, Mumbai, Maharashtra, India, Built clinical data management foundations over 3+ years, generating database queries and executing data validation checks across Phase I–III oncology and metabolic disease clinical trial data management operations.• • • Trained and mentored junior associates in data discrepancy identification and resolution; acted as designated POC for local laboratory site data coordination across 5+ multi-country studies. Created and maintained site-specific user documentation for local lab data handling, standardising practices across studies and reducing site-level query volumes. Demonstrated strong communication and stakeholder management skills, recognised for self-motivation and ability to manage multiple study workstreams simultaneously without supervision. ★ KEY CONTRIBUTION: Received internal recognition for creating a lab documentation template adopted programme-wide

Education

Master's degree, Pharmacology, R.C.P.I.P.E.R

Bachelor of Pharmacy (B.Pharm.), Pharmacology, North Maharashtra University