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Sr. Centralized Study Coordinator

Fortrea
Fortrea
2+ years
Not Disclosed
Bangalore, India
10 May 18, 2026
Job Description
Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Centralized Study Coordinator

Location: Bangalore, India
Employment Type: Full-Time
Job ID: 261436
Application Deadline: June 30, 2026


Job Overview

The Senior Centralized Study Coordinator supports clinical study management activities across systems, documentation, reporting, and operational processes. This role ensures efficient coordination of study tasks, compliance with SOPs, and accurate execution of study-level activities in alignment with ICH-GCP and organizational standards.


Key Responsibilities

Clinical Systems & Study Setup

  • Manage clinical systems access and user permissions (CTMS, EDC, IWRS, etc.)

  • Maintain study databases and ensure data accuracy

  • Support system setup for newly awarded studies

  • Ensure CTMS compliance across assigned studies

  • Assist in project communications and coordination activities


Data Review & Study Support

  • Support study teams in data review activities

  • Follow up with CRAs to resolve outstanding issues and action items

  • Assist in generating study-specific reports and metrics

  • Provide operational support to study management teams

  • Assist in eTMF (electronic Trial Master File) management and documentation processes


Investigator Payments & Financial Operations

  • Review EDC and contract data to identify payment-ready items (e.g., “Ready to Pay” or “Screen Failure”)

  • Support generation of invoices, cover letters, and payment batches in CTMS

  • Perform invoice quality checks (QC) and prepare supporting documentation

  • Coordinate approvals with clinical and project teams (CTL, PM, etc.)

  • Process out-of-pocket and pass-through expense invoices

  • Support payment reconciliation during study close-out or ad hoc requests


Study Documentation & Compliance

  • Ensure adherence to all applicable SOPs, work instructions, and regulatory requirements

  • Support document management, including collection, tracking, review, and eTMF filing

  • Assist in preparation of investigator submission and regulatory packages

  • Support site start-up and study initiation activities

  • Follow up on document uploads and resolve related queries

  • Ensure timely escalation of issues and compliance with timelines


Quality & Reporting

  • Perform quality checks to ensure accuracy and completeness of work

  • Track and report study metrics as required by management

  • Support implementation of updated processes and procedures

  • Ensure consistent delivery of high-quality outputs


Qualifications

  • University/college degree in Life Sciences preferred, or allied health certification (e.g., nursing, laboratory, or medical technology)

  • 2–3 years of experience in clinical research

  • Strong understanding of ICH-GCP guidelines and regulatory requirements

  • Equivalent experience may be considered in lieu of formal education

  • Fluent in English (written and verbal)


Required Skills & Competencies

  • Strong organizational and coordination skills

  • High attention to detail and accuracy

  • Ability to manage multiple priorities in a fast-paced environment

  • Strong communication and teamwork skills

  • Proficiency with clinical systems and standard office tools

  • Ability to maintain consistent, high-quality output

  • Strong problem-solving and escalation management skills


Role Summary

This role plays a key operational support function in clinical trial execution, ensuring smooth coordination across systems, documentation, reporting, and payment processes. It requires strong attention to detail, regulatory awareness, and the ability to manage multiple study-related tasks efficiently.