Centralized Study Spec I in Bangalore, India - Jobeax
Vacancy description
Centralized Study Spec I in Bangalore, भारत
Fortrea
Bangalore, भारत
Fortrea seeks a Centralized Study Spec professional to support clinical trial operations in Bangalore. The role involves reviewing study documentation, managing informed consent forms, ensuring regulatory compliance, and coordinating with internal and sponsor teams to meet submission deadlines.
Responsibilities
Review and implement study-specific plans and protocols for assigned tasks
File task-related documentation in the Electronic Trial Master File (eTMF)
Review country and site ICFs for regulatory and sponsor compliance
Liaise with local teams and sponsors to ensure timely ICF approvals
Conduct quality checks and support process improvement initiatives
Requirements
University degree in life science or allied health certification
3-5 years clinical research work experience
Knowledge of ICH, FDA, IRB/IEC regulations and GCP guidelines
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