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Sr. Centralized Study Coordinator

Fortrea
Fortrea
2-3 years
Not Disclosed
Bangalore, India
7 May 11, 2026
Job Description
Job Type: Full Time 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

Job Title

Senior Centralized Study Coordinator

Company

Fortrea

Location

Bangalore, India

Employment Type

Full-time


Job Overview

This role supports clinical trial operations and study coordination activities across multiple clinical systems. You will be responsible for managing study documentation, databases, investigator payments, system access, and supporting clinical study teams throughout the trial lifecycle.


Key Responsibilities

1. Clinical Systems & Data Management

  • Manage clinical systems and user access (CTMS, IWRS, EDC, eTMF)

  • Maintain and update study databases

  • Perform system setup for newly awarded studies

  • Ensure CTMS compliance and data accuracy


2. Study Support & Reporting

  • Assist study teams with data review and issue resolution

  • Track and follow up with CRAs on pending actions

  • Generate study-specific reports and metrics

  • Support project communication activities


3. eTMF (Electronic Trial Master File) Support

  • Assist in document collection, processing, and filing

  • Support eTMF maintenance throughout study lifecycle

  • Ensure proper documentation management and tracking


4. Investigator Payments

  • Review EDC and contracts for payment readiness

  • Mark invoices as “Ready to Pay” or “Screen Failure” in CTMS

  • Prepare invoices, cover letters, and payment batches

  • Perform invoice quality checks (QC)

  • Handle reimbursements and expense processing

  • Support payment reconciliation during study close-out


5. Study Start-up & Contract Support

  • Assist in investigator site submission packages

  • Support site activation and start-up activities

  • Manage clinical trial contracts within timelines

  • Support startup teams with documentation and coordination


6. Quality & Compliance

  • Follow SOPs and Work Instructions strictly

  • Ensure adherence to ICH-GCP guidelines

  • Perform quality checks on completed work

  • Escalate issues and support timely resolution

  • Track and report operational metrics


7. Administrative & Operational Support

  • Support internal teams with documentation and system tasks

  • Assist in implementing process improvements

  • Manage project documentation in an organized manner

  • Support cross-functional clinical operations activities


Required Qualifications

  • University/College degree (Life Sciences preferred)

  • OR Nursing / Medical / Laboratory Technology certification

  • Equivalent experience may be considered


Required Experience

  • 2–3 years in clinical research or clinical operations

  • Strong understanding of:

    • ICH-GCP guidelines

    • Clinical trial processes and regulations


Required Skills

Technical Skills

  • Knowledge of clinical systems:

    • CTMS (Clinical Trial Management System)

    • EDC (Electronic Data Capture)

    • IWRS (Interactive Web Response System)

    • eTMF (Electronic Trial Master File)

  • Microsoft Office proficiency


Core Competencies

  • Strong attention to detail

  • Ability to manage multiple tasks

  • Good organizational skills

  • High-quality work delivery

  • Ability to follow structured processes


Soft Skills

  • Strong communication skills (written & verbal)

  • Team collaboration

  • Problem-solving ability

  • Time management

  • Ability to escalate issues appropriately


Role Summary (Simple Explanation)

This is an entry-to-mid level clinical trial operations role focused on:

  • Managing clinical trial systems (CTMS, EDC, eTMF)

  • Supporting study teams and CRAs

  • Handling investigator payments and documentation

  • Ensuring compliance with clinical trial regulations (GCP)

  • Supporting study start-up and reporting activities


Key Insight

  • Suitable for 2–3 years clinical research experience

  • Strong entry point into Clinical Research Operations / Clinical Data Management

  • Less technical, more operations + coordination + documentation