Centralized Study Spec II in Bangalore, India - Jobeax
Vacancy description
Centralized Study Spec II in Bangalore, भारत
Fortrea
ContractFixed-term or freelance
Bangalore, भारत
Fortrea seeks a Centralized Study Spec II professional to manage clinical trial agreements, protocol amendments, and site contracting activities. The role involves drafting contracts, coordinating with cross-functional teams, maintaining documentation systems, and ensuring compliance with ICH-GCP standards and sponsor requirements.
Responsibilities
Draft, review, negotiate, and finalize clinical trial agreements, confidentiality agreements, and site contracts
Coordinate with sponsors, legal teams, and study teams to ensure timely contract execution and milestone alignment
Manage protocol amendment submissions and coordinate associated documentation updates across sites and systems
Track contract and amendment progress, maintain accurate status updates in SAMS and UCV systems
Identify contracting risks and delays proactively, escalating issues to management and providing regular progress updates
Requirements
University degree in life sciences or allied health certification (nursing, medical technology)
3-5 years clinical research experience with strong ICH-GCP knowledge
Expertise in clinical trial contracting and protocol amendment processes
Excellent communication, negotiation, and stakeholder management abilities
Proficiency with contract tracking systems and Microsoft Office applications
Strong organizational skills and ability to manage multiple priorities simultaneously
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