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    Sr. Centralized Study Coordinator

    Fortrea
    Fortrea
    2-3 years
    preferred by company
    Bangalore, India
    1 May 12, 2026
    Job Description
    Job Type: Hybrid Education: M.Pharm/B.Pharm or M.Sc. Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing

    Sr. Centralized Study Coordinator | Clinical Research Operations & Study Management Support

    Job Location: Bangalore, India
    Job Type: Full-Time
    Department: Clinical Operations / Clinical Research / Study Management
    Work Mode: Office-Based / Hybrid / As per business requirements
    Experience Required: 2–3 Years
    Freshers Eligible: No
    Industry: Clinical Research / Pharmaceuticals / Biotechnology / CRO / Healthcare

    Job Overview

    We are hiring a Senior Centralized Study Coordinator for a clinical research operations role in Bangalore. This opportunity is ideal for professionals with experience in clinical trial coordination, study management support, CTMS administration, investigator payment processing, eTMF management, and clinical systems support.

    The selected candidate will support end-to-end study operations, clinical documentation workflows, investigator payments, study database management, project communication, and compliance-driven study coordination activities.

    This role is highly suitable for professionals seeking growth in clinical operations, trial coordination, study startup, clinical systems administration, and pharmaceutical research support.

    Key Responsibilities

    Clinical Study Operations Support

    • Support clinical study teams with day-to-day operational coordination activities.
    • Manage clinical trial systems and user access management.
    • Maintain and administer clinical study databases including:
      • CTMS (Clinical Trial Management System)
      • IWRS (Interactive Web Response System)
      • EDC (Electronic Data Capture)
      • Other study management platforms
    • Support study setup activities for newly awarded clinical projects.
    • Manage CTMS compliance and system governance requirements.
    • Generate study-specific operational and performance reports.
    • Coordinate project communications and internal stakeholder support.

    Data Review & Clinical Documentation

    • Support study teams in clinical data review, issue tracking, and query management.
    • Follow up with Clinical Research Associates (CRAs) for resolution of outstanding issues.
    • Assist study leads with protocol-specific data review and documentation tasks.
    • Support eTMF document collection, review, processing, tracking, and filing.
    • Assist in investigator submission package preparation for site and regulatory submission activities.
    • Maintain project and technical documentation in compliance with SOPs and regulatory standards.

    Investigator Payment & Financial Coordination

    • Review EDC data, study contracts, and CTMS payment milestones to determine payment eligibility.
    • Mark payment line items such as Ready to Pay / Screen Failure within CTMS.
    • Coordinate with project administration teams for:
      • Cover letters
      • Proforma invoices
      • Payment batch generation
    • Perform invoice quality control checks and prepare required financial documentation (GIA where applicable).
    • Coordinate approvals with:
      • Clinical Trial Leads (CTL)
      • Project Managers (PM)
      • Internal stakeholders
    • Process:
      • Out-of-pocket expense invoices
      • Pass-through invoices
      • Investigator payments
    • Perform payment reconciliation during study closeout or ad hoc requests.

    Operational Excellence & Compliance

    • Follow departmental SOPs, work instructions, and quality processes.
    • Complete required compliance training within assigned timelines.
    • Ensure high productivity, accuracy, and quality in all assigned tasks.
    • Track operational metrics and report performance as required.
    • Escalate operational issues proactively for timely resolution.
    • Support implementation of updated workflows, tools, and process improvements.
    • Assist study startup teams with operational and site activation activities.
    • Support site contract review and study agreement management.

    Required Qualifications

    • University / College Degree (Life Sciences preferred) OR
    • Certification in allied health professions such as:
      • Nursing
      • Medical Technology
      • Laboratory Technology
      • Related healthcare disciplines
    • Equivalent relevant professional experience may be considered
    • Fluent English communication (written and verbal)

    Experience Requirements

    • Minimum 2–3 years of experience in clinical research, study coordination, clinical operations, or clinical trial support
    • Strong understanding of ICH-GCP guidelines and clinical research compliance standards
    • Experience with clinical systems, documentation workflows, or study coordination preferred
    • Freshers are not eligible

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