Centralized Study Analyst – Fortrea
Location
Bangalore, India
Job Type
Full-time (Hybrid)
Experience Required
3–5 years of experience in Clinical Research, Clinical Operations, Clinical Trial Management, or Study Coordination.
Prior experience working with clinical systems, eTMF, CTMS, EDC, and ICH-GCP guidelines is preferred.
Estimated Salary Package (Market Standard)
₹8 – ₹13 LPA (approx.), depending on experience, skills, and interview performance.
Job Overview
The Centralized Study Analyst provides operational and administrative support for global clinical studies by managing study systems, documentation, data review, investigator payments, and study communications. The role ensures regulatory compliance, supports study teams, and contributes to the smooth execution of clinical trials throughout the study lifecycle.
Key Responsibilities
Clinical Study Support
Manage clinical systems and user access.
Maintain study databases such as CTMS, IWRS, EDC, and related systems.
Support study teams with data review and operational activities.
Track and follow up with Clinical Research Associates (CRAs) on outstanding actions.
Generate study-specific reports and perform data analysis.
Manage internal and external study communications.
Monitor training compliance for study teams.
Support study start-up and close-out activities.
Document Review & eTMF Management
Review Investigator Packages for regulatory compliance.
Review amended Informed Consent Forms (ICFs) for compliance with sponsor and regulatory requirements.
File study documentation in TMF and eTMF systems.
Review Investigator Package Plans according to SOPs.
Assist in document collection, tracking, processing, and template management.
Prepare investigator submission packages for regulatory and site submissions.
Data Review
Follow up with CRAs to resolve outstanding issues.
Support study-specific data review activities.
Prepare and distribute study reports.
Perform additional data review activities assigned by project teams.
Investigator Payment Management
Review EDC and contract data for payment processing.
Process investigator and vendor payments through CTMS.
Perform invoice quality checks and payment reconciliation.
Coordinate approvals with Clinical Trial Leads (CTLs) and Project Managers.
Process out-of-pocket expenses and pass-through invoices.
Quality & Compliance
Follow Standard Operating Procedures (SOPs) and Work Instructions.
Complete mandatory training within required timelines.
Ensure high-quality and timely completion of assigned tasks.
Maintain project documentation and performance metrics.
Escalate issues appropriately and support resolution.
Participate in process improvement initiatives.
Educational Qualification
Bachelor's degree in Life Sciences (preferred), Pharmacy, Biotechnology, Nursing, Medical Laboratory Technology, or a related healthcare discipline.
Equivalent allied health certifications or relevant experience may also be considered.
Required Skills
Strong understanding of ICH-GCP guidelines and clinical research regulations.
Experience with CTMS, EDC, IWRS, eTMF, and other clinical trial systems.
Knowledge of clinical trial documentation and study management processes.
Excellent organizational and documentation skills.
Strong analytical and problem-solving abilities.
High attention to detail and accuracy.
Effective verbal and written communication skills.
Ability to work collaboratively in cross-functional teams.
Proficiency in Microsoft Office applications.
Preferred Qualifications
Experience in clinical trial start-up and study support activities.
Knowledge of investigator payment processing and site budget validation.
Experience with clinical trial contracts and regulatory submissions.
Familiarity with global clinical trial operations and document management systems.
Work Environment
Hybrid work model.
General office environment with collaboration across global clinical research teams.
Who Should Apply
Clinical Research Coordinators (CRC), Clinical Trial Associates (CTA), Clinical Operations professionals, and Study Support Specialists with 3–5 years of experience.
Candidates seeking to advance their careers in Clinical Trial Management, Clinical Operations, and Global Study Management within the CRO or pharmaceutical industry.
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