Fortrea Hiring Centralized Study Specialist II Jobs in Bangalore for experienced clinical research professionals supporting global study operations and compliance.
Company Overview
Fortrea is a global contract research organization (CRO) specializing in clinical development, regulatory services, and end-to-end clinical trial support. The company partners with pharmaceutical, biotechnology, and medical device organizations to accelerate the delivery of innovative therapies while maintaining the highest standards of quality, compliance, and patient safety. Fortrea Hiring Centralized Study Specialist II Jobs
With a strong global presence and a focus on operational excellence, Fortrea provides professionals with opportunities to work on complex, multi-regional clinical trials, collaborate with cross-functional global teams, and build long-term careers in clinical research operations.
Job Location & Employment Type
- Job Location: Bangalore, India
- Employment Type: Full-Time
- Work Model: Office-based / Project-based (as per study requirements)
- Industry: Clinical Research, CRO Operations
Open Positions / Department Details
- Position Title: Centralized Study Specialist II
- Department: Centralized Study Operations / Clinical Operations
- Job Requisition ID: 26194
- Experience Level: Senior / Specialist Level
This role supports global clinical research projects and plays a key role in study start-up, maintenance, and centralized study support activities. Fortrea Hiring Centralized Study Specialist II Jobs
Key Roles & Responsibilities
The Centralized Study Specialist II will serve as a core member of the project team, contributing to study execution, coordination, and compliance. Responsibilities include: Fortrea Hiring Centralized Study Specialist II Jobs
- Acting as the primary point of contact for investigative sites during study maintenance and start-up activities
- Collecting, reviewing, and tracking investigator and regulatory documents to support submissions to IRB/IEC, Ethics Committees, Regulatory Authorities, and third-party bodies
- Supporting preparation, negotiation, and execution of site agreements, confidentiality agreements, indemnification letters, and related contracts
- Maintaining contract trackers, regulatory logs, and paper/electronic filing systems
- Ensuring strict compliance with ICH-GCP, SOPs, regulatory guidelines, and sponsor requirements
- Communicating study updates effectively with Project Management, Clinical Operations, Start-Up, Vendor Management, and other functional teams
- Supporting centralized study systems including CTMS, IWRS, EDC, eTMF, and project governance tools
- Managing study documentation and ensuring ongoing audit readiness
- Supporting data integrity, quality checks, and resolution of study-related queries
- Monitoring metrics, timelines, milestones, and escalating risks proactively
- Preparing study reports, dashboards, and performance summaries
- Supporting site payments, vendor payments, invoice tracking, and reconciliation activities
- Managing Trial Master File activities including QC, filing, tracking, and archiving
- Supporting protocol amendments, personnel updates, and document revisions
- Assisting with EU CTIS submissions and regulatory maintenance activities under guidance
- Reviewing and customizing informed consent documents to meet country-specific requirements
- Coordinating vendor activities including translation, laboratories, IVRS/IWRS, and other service providers
- Mentoring junior team members and supporting process improvements
- Participating in internal and external meetings and documenting outcomes appropriately
Eligibility Criteria
Education
- Bachelor’s degree in Life Sciences (preferred)
- OR certification in allied health disciplines such as Nursing, Medical Technology, or Laboratory Sciences
- Equivalent relevant experience may be considered in place of formal education
Experience
- 6–8 years of relevant experience in clinical research, CROs, pharmaceutical companies, or healthcare environments
- Prior experience in study start-up, regulatory submissions, site maintenance, or centralized study operations is required
Skills Required
- Strong understanding of clinical trial processes and global regulations
- Working knowledge of ICH-GCP, IRB/IEC, Regulatory Authority requirements
- Experience handling investigator documents and site communications
- Familiarity with clinical systems such as CTMS, EDC, IWRS, and eTMF
- Excellent organizational and documentation skills
- Strong stakeholder management and negotiation abilities
- Ability to manage multiple studies and priorities simultaneously
- Advanced proficiency in Microsoft Word, Excel, and PowerPoint
- Strong written and verbal communication skills in English
- Ability to work independently with minimal supervision
- Basic project management and financial tracking skills
Fortrea Hiring Centralized Study Specialist II Jobs
Salary & Benefits
- Salary: As per company norms
- Competitive compensation aligned with experience and role scope
- Opportunities to work on global clinical trials
- Professional development and training programs
- Exposure to cross-functional and international project teams
Fortrea Hiring Centralized Study Specialist II Jobs
Selection Process
- Application screening
- Technical and competency-based interviews
- Final HR discussion
Selection stages may vary depending on project and business requirements.
How to Apply
Interested candidates can apply through the official Fortrea careers portal using Job Requisition ID: 26194.
Important Dates
- Last Date to Apply: February 28, 2026
Why Apply for This Pharma Job?
This role offers an opportunity to work at the center of global clinical trial operations with exposure to regulatory, start-up, vendor management, and study coordination activities. Professionals joining Fortrea gain hands-on experience with international studies, advanced clinical systems, and collaborative teams, making this an excellent career move for experienced clinical research professionals seeking leadership growth. Fortrea Hiring Centralized Study Specialist II Jobs
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent pharmaceutical and clinical research job information platform. We are not affiliated with Fortrea or involved in their hiring process. All job details are shared for informational purposes only. Candidates are advised to verify information directly through the official company website before applying. Fortrea Hiring Centralized Study Specialist II Jobs
Final Call-to-Action
If you have strong experience in clinical research operations and are ready to take on a senior centralized study role, apply now and advance your career with Fortrea. Fortrea Hiring Centralized Study Specialist II Jobs
