Job Title: Centralized Study Specialist I – Bangalore, India (Full-Time, Office-Based)
Company Overview:
Fortrea is a leading global provider of clinical development services, supporting pharmaceutical, biotechnology, and healthcare organizations in accelerating the delivery of innovative therapies. We foster an inclusive environment focused on operational excellence, regulatory compliance, and high-quality clinical research. Join us to contribute to the future of clinical trials and patient outcomes.
Position Summary:
We are seeking a highly motivated Centralized Study Specialist I to join our Bangalore office. This role plays a critical part in ensuring seamless execution of clinical trials by managing study systems, supporting site operations, monitoring metrics, and facilitating data management processes. You will collaborate with cross-functional teams, mentor colleagues, and contribute to process improvements that drive study efficiency and compliance.
Key Responsibilities:
Execute daily study activities in compliance with departmental SOPs, Work Instructions, and best practices.
Develop and maintain study documentation and systems including TMF, CTMS, IWRS, and EDC platforms.
Track site progress, follow up on outstanding issues with CRAs, and generate study-specific reports.
Support study start-up, training compliance, and vendor management activities including invoice tracking and purchase order requisitions.
Prepare CRA Prep Packs, liaise with CRAs and clinical teams, and ensure effective site visit planning.
Monitor project timelines, milestones, and compliance metrics, escalating issues proactively.
Assist Project Lead/Functional Lead with project plans, coordination, and execution.
Mentor junior team members and provide guidance on study management processes.
Support system customizations, documentation, and resolution of alerts in tools such as Xcellerate Intelligence for Trial Efficiency (XITE).
Actively participate in quality reviews and process improvement initiatives.
Qualifications & Experience:
Education: University/College degree in Life Sciences preferred, or certification in an allied health profession (e.g., Nursing, Medical, Laboratory Technology).
Experience: Minimum 5–8 years of relevant clinical research experience in pharmaceutical, CRO, or healthcare settings.
Familiarity with clinical trial start-up documents, contracts, budgets, and investigator site interactions is preferred.
Working knowledge of ICH-GCP, regulatory authority requirements, IRB/IEC procedures, and other applicable clinical trial guidelines.
Demonstrated organizational, communication, and time management skills.
Strong computer proficiency with Microsoft Office Suite (Word, Excel, PowerPoint) and study management systems.
Preferred Attributes:
Ability to work in shifts if required.
Experience mentoring junior team members.
Strong attention to detail and commitment to high-quality outputs.
Why Join Fortrea:
Work with global clinical research experts across diverse therapeutic areas.
Competitive salary and benefits package.
Opportunities for professional growth and cross-functional exposure.
Collaborative, inclusive, and performance-driven work culture.
Fortrea is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, or veteran status. Reasonable accommodations are available for applicants with disabilities throughout the hiring process.
Apply Now to be part of a team that drives innovation and excellence in global clinical research.
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