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Fortrea, a leading global Contract Research Organization (CRO), is hiring an experienced Centralized Study Specialist II for its Bangalore location. This full-time role is ideal for clinical research professionals with strong experience in study start-up, regulatory maintenance, centralized monitoring, and clinical trial systems.
The Centralized Study Specialist II plays a pivotal role in global clinical trials, supporting project teams, investigative sites, sponsors, and vendors to ensure studies are executed in compliance with ICH-GCP, regulatory requirements, and Fortrea SOPs.
🔬 Key Responsibilities
Study Start-Up & Maintenance
- Act as primary contact for investigative sites during study maintenance
- Collect, review, and track essential regulatory documents
- Support EC/IRB/IEC/Regulatory Authority submissions
- Manage site agreements, confidentiality agreements, and contracts
- Maintain contract tracking systems and documentation repositories
Centralized Study Support
- Support Project Management, Start-up, Clinical Operations, Vendor Management
- Maintain and manage eTMF, CTMS, IWRS, EDC, XRIM, XITE
- Prepare CRA Prep Packs and resolve site-level issues
- Track metrics, dashboards, timelines, and milestones
- Support study payments, invoices, and reconciliation
- Ensure TMF QC, compliance metrics, and audit readiness
Regulatory & Amendment Management
- Compile and submit documents for IND/CTA and amendments
- Customize Informed Consent Forms (ICFs) as per country regulations
- Support CTIS uploads (EU studies)
- Track protocol deviations and regulatory impacts
- Support site agreement negotiations and approvals
Leadership & Collaboration
- Mentor and train junior team members
- Act as Subject Matter Expert (SME) for systems and processes
- Facilitate internal and external study meetings
- Proactively identify process improvements
- Exhibit strong stakeholder management and negotiation skills
🎓 Qualifications & Experience
Minimum Requirements
- Life Sciences degree (B.Pharm, M.Pharm, MSc, Nursing, Allied Health preferred)
- 6–8 years of clinical research experience in CRO, pharma, or healthcare
- Strong knowledge of ICH-GCP, regulatory guidelines, IRB/IEC processes
- Experience with study start-up, regulatory maintenance, and contracts
- Hands-on experience with clinical trial systems (CTMS, eTMF, IWRS, EDC)
Key Skills
- Clinical trial planning and execution
- Regulatory submissions & documentation
- Contract and budget negotiation
- Study financial acumen
- Advanced MS Excel, Word, PowerPoint
- Excellent written and verbal English communication
- Ability to work independently in a matrix environment
💼 Salary & Benefits (Indicative)
- Salary Range: ₹12,00,000 – ₹18,00,000 per annum (INR)
- Competitive CRO compensation structure
- Global exposure across multi-regional clinical trials
- Career growth in centralized monitoring and regulatory operations
- Opportunity to deputize for functional leads
- Hybrid/global collaboration environment
📍 Job Location
Bangalore, Karnataka, India
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📅 Important Dates
- Date Posted: January 29, 2026
- Last Date to Apply: February 28, 2026
📝 How to Apply
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