Centralized Study Spec II in 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