Contracts Specialist II – Site Agreements
Location: Bangalore, India
Category: Clinical Research / Site Contracts
Job ID: 255960
Work Mode: Office-Based
Job Overview
We are hiring a Contracts Specialist II – Site Agreements to support global clinical research operations by managing, negotiating, and executing site-related contracts. This role is critical to ensuring timely site activation, regulatory compliance, and smooth coordination between investigative sites, sponsors, and internal clinical teams.
The position requires strong experience in clinical trial site agreements, regulatory submissions, and contract lifecycle management within a CRO or pharmaceutical environment.
Key Responsibilities
Prepare, draft, negotiate, and manage site agreements, confidentiality agreements, letters of indemnification, and related clinical research contracts
Act as the primary point of contact for investigative sites during site maintenance activities
Ensure timely collection and review of investigator and essential documents to support IRB/IEC, Regulatory Authority, and third-party submissions
Track, negotiate, approve, and maintain site agreements using the Site Agreement Management System (SAMS) or other study-specific systems
Ensure compliance with SOPs, sponsor requirements, ICH-GCP guidelines, and applicable regulatory standards
Identify contractual, regulatory, or operational risks and escalate issues to line management as per departmental processes
Liaise with internal stakeholders and external vendors to support regulatory submissions and approvals
Review final submission documentation to ensure accuracy, completeness, and regulatory compliance
Oversee and validate tasks delegated to Contracts Associates to ensure quality and adherence to processes
Maintain accurate and timely updates in departmental contract tracking and reporting systems
Support contract administration activities including approvals, execution tracking, document filing, and communication of executed contracts to study teams
Upload and monitor submission documentation in CTIS, ensuring trial milestones are met within mandated timelines
Provide regular contract status updates to management, highlighting risks, delays, or out-of-scope efforts
Support departmental goals, process improvements, and continuous operational enhancements
Coordinate closely with clinical study teams to ensure contract timelines align with study start-up and delivery objectives
Perform all required training, timesheet entries, and expense reporting in compliance with corporate policies
Required Qualifications
Bachelor’s degree in Law, Business, Life Sciences, or related field
LLB, JD, BA, or BS preferred
University-level law degree (UK/EU) is an advantage
Relevant and equivalent experience may be considered in lieu of formal education
Experience Requirements
Minimum 2 to 4 years of experience in clinical trial site agreements, contracts management, or clinical research administration
Hands-on experience within a CRO, pharmaceutical, biotechnology, or clinical research organization preferred
Proven experience negotiating site contracts and coordinating regulatory submissions
Skills & Competencies
Strong understanding of clinical trial contracting, site start-up, and regulatory processes
Working knowledge of ICH-GCP principles and clinical research regulations
Excellent negotiation, communication, and stakeholder management skills
High attention to detail with strong organizational and documentation skills
Ability to manage multiple studies and deadlines simultaneously
Proficiency in contract tracking systems and Microsoft Office applications
Ability to work independently with minimal supervision while collaborating effectively with cross-functional teams
Work Environment
100% office-based role
Standard corporate clinical research work environment
Why Join This Role
This position offers the opportunity to work on global clinical trials, gain exposure to complex site contracting processes, and contribute directly to the successful execution of regulated clinical research programs.
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