Headline

Driving Global Clinical Trials | Biosample Lifecycle & Biomarker Ops | 8+ Years | GCP | CTMS | Pharma & CRO Experience

About

Results-driven Life Sciences professional with 9+ years of progressive experience spanning biosimilar characterization, clinical trials management, biosamples operations, and market intelligence. Currently serving as Senior Process Associate (Biosamples Management Associate) at Tata Consultancy Services supporting Roche's global clinical studies. Proven expertise in PK/ADA sample logistics, clinical trial documentation, cross-functional stakeholder collaboration, and process quality control (PQC). Certified in Six Sigma, High-Stakes Communication, and Market Research. Adept in regulatory systems including eTMF, Medidata RAVE, Veeva Vault, and CTMS platforms.

Location

Mumbai

Work experience

Bio samples management Associate at Tata Consultancy Services, Apr 2022 - Present · 4 yrs 3 mos, Mumbai, Maharashtra, India, Manage end-to-end biosample lifecycle including shipment tracking, reconciliation, and storage. Coordinate with biomarker teams, central labs, and global stakeholders. Conduct study kickoff meetings and maintain clinical documentation. Track patient recruitment and site activation using CTMS. Lead knowledge sharing, SOP adherence, and training initiatives. Drive process improvements and ensure data quality across studies.

Module Lead at Ascentrik Research Pvt Ltd, Sep 2021 - Apr 2022 · 8 mos, Pune District, Maharashtra, India

Senior Clinical Research Associate (Module Analyst) at Ascentrik Research Pvt Ltd, Oct 2020 - Aug 2021 · 11 mos, Pune District, Maharashtra, India

Senior Scientist at Biocon, Sep 2019 - Jan 2020 · 5 mos, Banglore

Research Associate at Ipca Laboratories Limited, Dec 2015 - Mar 2019 · 3 yrs 4 mos, Mumbai, Maharashtra, India

Education

Data Analyst Fellowship, Data Analytics, Nextleap

Post Graduate Diploma, Clinical research, MITCON Consultancy and Engineering Services