Centralized Study Specialist I

Overview

Centralized Study Specialist I to execute day-to-day centralized study monitoring, reporting, and document/record management for clinical studies.

What you'll do

• Follow departmental Standard Operating Procedures and Work Instructions and complete daily tasks.
• Run monitoring and specialized monitoring requests, and produce timely monitoring reports.
• Track and report study metrics and proactively suggest process improvements.
• Manage clinical systems, study documents, and maintain study databases (CTMS, IWRS, EDC).
• Support CRA follow-ups for outstanding site issues and help generate study-specific reports.
• Maintain Trial Master File documentation in the TMF platform and participate in TMF QC as assigned.
• Update timelines/milestones in MS Project, CTMS, and trackers; escalate when timelines are at risk.

What you'll need

• Minimum 3+ years of experience in clinical development or start-up/regulatory process.
• 5–8 years of relevant clinical research experience in pharmaceutical/CRO industries or healthcare settings.
• Working knowledge of ICH, RA, IRB/IEC, and applicable regulations/guidelines.
• Basic understanding of the clinical trial process.
• Ability to organize and communicate effectively.
• Computer literacy including Microsoft Office (Word, Excel, PowerPoint).
• Demonstrated attention to detail and ability to deliver consistent high-quality work.

Details

• Location: Bangalore.