Fortrea, a global Contract Research Organization (CRO), is hiring a Centralized Study Specialist I for its Bangalore location. This full-time opportunity is ideal for experienced clinical research professionals with strong exposure to CTMS, eTMF, EDC, study operations, and ICH-GCP compliance.
The role plays a critical part in centralized study operations, supporting clinical teams, CRAs, vendors, and project leads to ensure high-quality, compliant, and timely trial execution.
🔑 Key Responsibilities – Centralized Study Specialist I
As a Centralized Study Specialist / Analyst, you will be responsible for:
- Following departmental SOPs and Work Instructions
- Executing monitoring, reporting plans, and specialized study requests
- Managing clinical systems such as CTMS, IWRS, EDC
- Supporting eTMF management, TMF QC, archival, and compliance metrics
- Tracking CRA action items and outstanding site issues
- Preparing CRA Prep Packs prior to site visits
- Supporting study payments (site and vendor)
- Generating study-specific reports and dashboards
- Managing internal and external study communications
- Supporting training compliance for study teams
- Maintaining study timelines and milestones using MS Project & CTMS
- Initiating RIM changes, managing PCC logs, and documentation impact tracking
- Assisting with vendor management, invoice tracking, and PO requisitions
- Handling PII assessments, XRIM documentation, and system updates
- Supporting Xcellerate Intelligence / Trial Efficiency (XITE) alerts and customization
- Mentoring junior team members and supporting cross-functional collaboration
Senior-level responsibilities may include leading centralized delivery teams and facilitating stakeholder communication.
🎓 Qualifications & Experience
Minimum Qualifications
- Bachelor’s or Master’s degree in Life Sciences (preferred)
or certification in allied health professions (Nursing, Lab Technology, etc.) - 5–8 years of clinical research experience in CRO, pharmaceutical, or healthcare settings
- Strong understanding of ICH-GCP, IRB/IEC, regulatory requirements
- Experience with investigator start-up documents, budgets, and contracts (preferred)
- Prior interaction with CRAs, project teams, and investigative sites
Required Skills
- Strong organizational and time-management skills
- High attention to detail and data accuracy
- Excellent communication and collaboration abilities
- Proficiency in Microsoft Word, Excel, PowerPoint
- Ability to manage multiple systems and trackers efficiently
Preferred
- Willingness to work in shifts, if required
- Experience with centralized monitoring or study operations
💼 Why Join Fortrea?
- Global CRO exposure with complex clinical trials
- Strong focus on process excellence and compliance
- Opportunities for leadership and career growth
- Collaborative, cross-functional work environment
- Competitive compensation and benefits
📍 Job Location
Bangalore, Karnataka, India
💰 Salary (Estimated)
₹8,00,000 – ₹14,00,000 per annum
(Salary may vary based on experience, skills, and internal assessment)
📝 How to Apply
