Site Contracts Associate II

Overview

A partner organization is seeking a Site Contracts Associate II based in India to support clinical trial execution. This role involves drafting, negotiating, and managing clinical site agreements in compliance with regulatory standards and study requirements. The position requires close collaboration with clinical sites, internal study teams, and cross-functional stakeholders to ensure contract lifecycles are managed efficiently from initiation through execution.

Responsibilities

• Draft, review, and negotiate clinical site agreements and related documents such as service agreements, amendments, letters, and notices.
• Ensure contract terms align with study budgets, negotiation parameters, protocols, timelines, and applicable legal and regulatory requirements including ICH-GCP.
• Serve as a liaison between internal teams and clinical sites to communicate contract status, updates, and resolve outstanding issues.
• Manage the full contract execution process, coordinating signatures and ensuring timely completion by all parties.
• Maintain accurate records, tracking systems, and archived documentation in compliance with SOPs and regulatory standards.
• Identify risks, inconsistencies, or issues in contract terms and collaborate with stakeholders to resolve them.
• Support site contracting strategy discussions and contribute to process improvements to enhance efficiency and quality.
• Monitor contracting timelines and milestones, ensuring adherence to delivery schedules and escalating issues as needed.
• Ensure completeness of required documentation such as insurance certificates, indemnification letters, and informed consent-related materials.

Requirements

• 2–5 years of experience in site contracting, clinical operations, or a related role within the CRO or life sciences industry.
• Bachelor’s degree in law, business, economics, social sciences, or a related field, or equivalent professional experience.
• Strong understanding of clinical trial processes, site agreements, and regulatory requirements such as ICH-GCP.
• Excellent negotiation, analytical, and contract interpretation skills with strong attention to detail.
• Ability to manage multiple contracts and priorities in a fast-paced, deadline-driven environment.
• Strong written and verbal communication skills in English; additional languages are a plus.
• Proficiency in MS Office tools, particularly Excel, Word, and PowerPoint.
• Ability to work effectively in a virtual, cross-functional, and global team environment.
• Strong problem-solving mindset with the ability to identify issues and implement practical solutions.
• High level of professionalism, organization, and accountability in all deliverables.

Benefits

• Opportunity to contribute directly to global clinical trials supporting the development of life-changing therapies.
• Fully remote working model based in India.
• Exposure to international stakeholders and cross-functional clinical research teams.
• Structured learning and development opportunities within the clinical research industry.
• Strong focus on quality, compliance, and professional growth.
• Collaborative environment centered on improving patient outcomes.
• Opportunity to build deep expertise in site contracting and clinical operations.

Location

• Remote position based in India.