Nandhini Mahendran

Detail-oriented clinical research professional with a PG Diploma in Advanced Clinical Research and practical experience gained through an independent clinical research practicum in site activation support., essential document management, and GCP-compliant monitoring workflows. Proficient in SDV tracking, CTMS data entry, and TMF filing — skills developed through an independent clinical research practicum aligned with ICH-GCP E6 R2 standards. Experienced in regulated documentation environments through current employment in stem cell processing, demonstrating audit readiness, SOP adherence, and data integrity.

Seeking a role in clinical operations at a global CRO to contribute to site activation, document management, and trial conduct activities.

Process Assistant (Stem Cell Processing) at Transcell Bioscience Pvt. Ltd. (2024-06 – Present)

• Maintained essential documents and records in a GCP-aligned regulated environment, supporting audit and inspection readiness requirements
• Performed detailed data verification and review of batch records, ensuring accuracy, consistency, and traceability of all assigned documentation.
• Identified documentation discrepancies and coordinated corrective actions, reflecting site-level query resolution and process improvement practices
• Supported process documentation and strict adherence to SOPs across compliance-driven workflows
• Collaborated with cross-functional teams to ensure timely task completion and smooth operational workflow

PG Diploma in Advanced Clinical Research – Learning Lab Research Institute (2024)

B. Tech in Biotechnology – Vivekanandha College of Engineering for Women (2024)