Centralized Study Specialist I Job at Fortrea in Bangalore for experienced clinical research professionals with centralized monitoring and study systems expertise.
Job Title: Centralized Study Specialist I
Company: Fortrea
Location: Bengaluru, India
Employment Type: Full-Time
Work Model: Office-based / Hybrid (project dependent)
Industry: Clinical Research / Clinical Operations
Experience Required: Minimum 3+ years (overall 5–8 years preferred)
Application Mode: Online Application
Fortrea is hiring a Centralized Study Specialist I for its Bangalore location. This role is intended for experienced clinical research professionals with strong exposure to centralized study operations, clinical trial systems, and cross-functional coordination. The position plays a key role in supporting global clinical trials by ensuring operational efficiency, documentation quality, and regulatory compliance across the study lifecycle. Centralized Study Specialist I Job at Fortrea
About the Company
Fortrea is a global Contract Research Organization (CRO) delivering end-to-end clinical development, pharmacovigilance, and regulatory services to pharmaceutical, biotechnology, and medical device companies worldwide. Operating under strict global regulatory standards such as ICH-GCP, Fortrea supports clinical trials across multiple phases and therapeutic areas. Its centralized study teams enable efficient trial delivery, data integrity, and inspection readiness for global programs. Centralized Study Specialist I Job at Fortrea
Job Details
- Job Title: Centralized Study Specialist I
- Company Name: Fortrea
- Job Location: Bengaluru, India
- Employment Type: Full-Time
- Functional Area: Centralized Study Operations / Clinical Operations
- Experience Level: 3+ years required (5–8 years preferred)
- Industry: Clinical Research / CRO
Job Description
The Centralized Study Specialist I supports day-to-day centralized study activities including monitoring execution, system maintenance, documentation management, and coordination with CRAs, vendors, and cross-functional teams. The role ensures studies are conducted efficiently, within timelines, and in compliance with regulatory and operational standards.
Key Responsibilities
Centralized Monitoring & Study Support
- Execute centralized monitoring and reporting plans for approved protocols
- Support specialized monitoring requests from study management
- Track, analyze, and report study metrics within defined timelines
- Identify process improvement opportunities and support implementation
- Mentor and train junior team members when required
Centralized Study Specialist I Job at Fortrea
Clinical Systems & Documentation Management
- Manage clinical trial systems including CTMS, IWRS, EDC, and other databases
- Support eTMF management, document filing, tracking, and quality control
- Maintain Trial Master File documentation and support TMF QC and archiving
- Document study activities using approved tracking and project tools
Centralized Study Specialist I Job at Fortrea
CRA and Site Coordination
- Track and follow up with CRAs on outstanding actions
- Prepare and distribute CRA Prep Packs prior to site visits
- Coordinate with CRAs and clinical teams to resolve site-related issues
- Provide consolidated issue snapshots to support efficient monitoring visits
Study Operations & Financial Support
- Generate study-level operational and compliance reports
- Track training compliance for study teams
- Support site and vendor payment activities
- Assist with vendor invoice tracking and PO requisitions
Project Governance & Advanced Support
- Update study timelines and milestones in CTMS, MS Project, and governance tools
- Escalate risks related to timelines or deliverables
- Support project leads with study planning and execution
- Initiate RIM changes, manage PCC logs, and track documentation impacts
- Support PII assessments, XRIM updates, and system documentation
- Assist with Xcellerate Intelligence for Trial Efficiency (XITE) customizations
Centralized Study Specialist I Job at Fortrea
Skills / Qualifications
Educational Qualification
- University or college degree (Life Sciences preferred)
- Allied health qualifications such as Nursing, Medical Technology, or Laboratory Technology may be considered
Relevant Backgrounds Include:
BSc Life Sciences, Biotechnology, Microbiology, BPharm, MPharm, MSc Clinical Research, MSc Biotechnology, MSc Life Sciences, Nursing, Medical Laboratory Technology Centralized Study Specialist I Job at Fortrea
Experience Requirements
- Minimum 3+ years in clinical development, start-up, or regulatory processes
- Overall 5–8 years of relevant clinical research experience preferred
- Prior experience in CRO, pharmaceutical, or healthcare environments
- Exposure to investigator start-up documents and site coordination preferred
- Familiarity with contracts, budgets, or vendor coordination is an advantage
Centralized Study Specialist I Job at Fortrea
Regulatory Knowledge & Skills
- Working knowledge of ICH-GCP, IRB/IEC, and clinical trial regulations
- Understanding of end-to-end clinical trial lifecycle
- Strong organizational, communication, and time management skills
- High attention to detail and quality-focused approach
- Proficiency in MS Word, Excel, and PowerPoint
Benefits / Perks
- Competitive salary aligned with clinical operations roles
- Exposure to global clinical trial programs
- Hands-on experience with advanced clinical systems
- Strong learning and long-term career growth opportunities
- Collaborative and compliance-driven work environment
Centralized Study Specialist I Job at Fortrea
Why You Should Join
This role offers a strong pathway for professionals looking to grow in centralized study operations, project coordination, and clinical operations leadership. At Fortrea, you will gain global exposure, system expertise, and opportunities to advance into senior study management and project leadership roles. Centralized Study Specialist I Job at Fortrea
How to Apply
Application Deadline: January 31, 2026
FAQs
Who can apply for this role?
Candidates with a life sciences or allied health degree and at least 3 years of clinical research experience.
Is this role suitable for freshers?
No. Prior CRO or clinical research experience is required.
What systems will I work with?
CTMS, IWRS, EDC, eTMF, MS Project, and other clinical trial systems.
Does the role involve leadership responsibilities?
Yes. The role includes mentoring, coordination, and study-level leadership support.
What are the career growth opportunities?
This role can lead to senior centralized study, project management, and clinical operations leadership positions.
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