Looking for a Centralized Study Analyst job in Bangalore with a leading global CRO? A reputed clinical research organization is hiring experienced professionals with 3–5 years of clinical research experience to support centralized study operations, CTMS management, eTMF oversight, and compliance tracking.
This opportunity is ideal for candidates with experience in clinical trial management systems (CTMS), eTMF management, ICH-GCP compliance, study documentation, CRA coordination, and project tracking within pharmaceutical or CRO environments.
With strong exposure to clinical trial process management, regulatory documentation, study payments, and TMF quality control, this role offers excellent growth in centralized clinical operations.
📌 Job Overview – Centralized Study Analyst
- Role: Centralized Study Analyst
- Location: Bangalore, India
- Employment Type: Full Time
- Experience Required: 3–5 Years
- Industry: Clinical Research / CRO / Pharmaceutical
- Shift Requirement: Flexible / Shift-based
🔬 Key Responsibilities
The Centralized Study Analyst will support end-to-end clinical study coordination and operational management, including:
Clinical Systems & Database Management
- Manage clinical systems access (CTMS, IWRS, EDC)
- Maintain study databases and tracking tools
- Update project timelines, milestones, and governance tools
- Implement study-level customizations in XITE (upon approval)
eTMF & Documentation Oversight
- Maintain Trial Master File (TMF) documentation
- Participate in TMF QC activities
- Archive study documents appropriately
- Track compliance metrics (TMF, CTMS, project health)
Study Operations Support
- Prepare and send CRA Prep Packs before site visits
- Track outstanding site issues and escalate risks
- Generate study-specific operational reports
- Maintain communication between CRAs, Clinical Team, and Vendors
- Assist in vendor management, invoice tracking, PO requisitions
Risk & Compliance Management
- Update XRIM (Risk Identification & Issue Resolution tool)
- Track protocol deviations and risk mitigation actions
- Support ICH-GCP compliance and regulatory adherence
- Manage training compliance for study teams
Financial & Administrative Coordination
- Manage study payments (Site & Vendor)
- Maintain PCC logs and RIM changes
- Support contract and budget tracking processes
🎓 Qualifications Required
- University/College Degree (Life Sciences preferred)
- OR Certification in Nursing / Medical Laboratory Technology / Allied Health
- Working knowledge of:
- ICH-GCP Guidelines
- IRB/IEC processes
- Regulatory Affairs procedures
- Clinical trial documentation lifecycle
- Familiarity with investigator start-up documentation (preferred)
- Experience in project coordination within CRO or pharmaceutical industry
💼 Experience Required
- 3–5 years of relevant clinical research experience
- Experience in:
- CTMS management
- eTMF maintenance
- Study documentation tracking
- CRA coordination
- Clinical trial database oversight
- Strong Microsoft Office proficiency (Word, Excel, PowerPoint)
- Excellent organizational and communication skills
💰 Salary & Benefits (Estimated)
- Expected Salary Range: ₹8,00,000 – ₹12,00,000 per annum (based on experience)
- Exposure to global clinical projects
- Strong learning curve in centralized trial management
- Opportunities for cross-functional collaboration
- Career growth in clinical operations and project management
🌍 Why This Role Matters
The Centralized Study Analyst plays a critical role in ensuring:
- High-quality clinical trial documentation
- Regulatory compliance under ICH-GCP standards
- Effective coordination between CRAs, clinical teams, and vendors
- Accurate data tracking across CTMS, EDC, and TMF platforms
This role is essential for maintaining clinical trial efficiency, inspection readiness, and study milestone adherence.
📩 How to Apply
