Contracts Specialist II – Site Agreements
Location: Bangalore, India
Category: Clinical / Regulatory Operations
Employment Type: Full-Time
Experience Required: 2–4 years
Job Overview
We are seeking a Contracts Specialist II – Site Agreements to join our Bangalore team, responsible for preparing, negotiating, and managing clinical study site agreements, confidentiality agreements, letters of indemnification, and other contracts with sponsors. This role ensures all contractual obligations are met in compliance with internal SOPs, sponsor requirements, and applicable regulatory guidelines. The Contracts Specialist II serves as the primary interface with investigative sites and supports project timelines for regulatory submissions and site readiness activities.
The ideal candidate will have experience in clinical contracts management, site agreement negotiation, and regulatory operations within the pharmaceutical or clinical research environment.
Key Responsibilities
Draft, review, negotiate, and execute site agreements and related contracts for clinical studies, ensuring alignment with sponsor requirements and company policies.
Maintain and update contract tracking systems (e.g., Site Agreement Management System) and ensure accurate documentation for all executed contracts.
Interface with investigative sites to collect required investigator and essential documents, ensuring timely submission to EC/IRB/Third Party/Regulatory Authorities.
Monitor contract approval workflows, escalate issues, and collaborate with line managers, project teams, Business Development, and Budgets & Proposals staff to resolve delays.
Support regulatory submissions by liaising with internal and external vendors, reviewing final submission documents, and ensuring compliance with ICH-GCP standards.
Provide guidance to junior contracts staff and ensure delegated tasks are completed accurately and on time.
Track contract deliverables, identify potential risks, and proactively escalate to Submission Leads or line management.
Contribute to the development and continuous improvement of departmental processes, SOPs, and best practices.
Ensure all corporate compliance requirements are fulfilled, including timesheet entry, training documentation, and expense reporting.
Required Qualifications & Experience
Education: Bachelor’s degree (LLB, JD, BA, or BS) preferred; a university-level law degree (UK/EU) is advantageous. Fortrea may consider relevant and equivalent experience in lieu of formal education.
Experience: Minimum 2–4 years in contracts management, clinical site agreements, regulatory operations, or related areas within the pharmaceutical, biotechnology, or CRO industry.
Strong understanding of clinical study contracts, regulatory requirements, and sponsor obligations.
Knowledge of ICH-GCP principles and ability to apply them to contracting and site agreement management.
Excellent communication, negotiation, and interpersonal skills for engaging with internal teams and external stakeholders.
Detail-oriented with strong organizational and tracking skills to manage multiple projects simultaneously.
Work Environment
100% office-based in Bangalore, India.
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