This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Site Contracts Associate II based in India.
This role sits at the core of clinical trial execution, ensuring that site agreements are accurately drafted, negotiated, and executed in alignment with regulatory standards and study requirements. You will work closely with clinical sites, internal study teams, and cross-functional stakeholders to manage contract lifecycles from initiation through execution. The position requires strong attention to detail, legal and contractual interpretation skills, and the ability to balance compliance with operational timelines. You will play a key role in supporting clinical research studies that ultimately contribute to the development of life-changing therapies. The environment is highly collaborative, quality-driven, and fast-paced, with a strong emphasis on accuracy, communication, and regulatory compliance. This is an opportunity to contribute directly to the success of global clinical trials while building expertise in site contracting and clinical operations.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Site Contracts Associate II based in India.
This role sits at the core of clinical trial execution, ensuring that site agreements are accurately drafted, negotiated, and executed in alignment with regulatory standards and study requirements. You will work closely with clinical sites, internal study teams, and cross-functional stakeholders to manage contract lifecycles from initiation through execution. The position requires strong attention to detail, legal and contractual interpretation skills, and the ability to balance compliance with operational timelines. You will play a key role in supporting clinical research studies that ultimately contribute to the development of life-changing therapies. The environment is highly collaborative, quality-driven, and fast-paced, with a strong emphasis on accuracy, communication, and regulatory compliance. This is an opportunity to contribute directly to the success of global clinical trials while building expertise in site contracting and clinical operations.
Accountabilities:
- Draft, review, and negotiate clinical site agreements and related documents including service agreements, amendments, letters, and notices.
- Ensure contract terms align with study budgets, negotiation parameters, protocols, timelines, and applicable legal and regulatory requirements such as ICH-GCP.
- Act as a key liaison between internal teams and clinical sites, ensuring clear communication of contract status, updates, and outstanding issues.
- Manage the full contract execution process, including coordinating signatures and ensuring timely completion by all stakeholders.
- 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 effectively.
- Support site contracting strategy discussions and contribute to process improvements to enhance efficiency and quality.
- Monitor contracting timelines and milestones, ensuring adherence to agreed delivery schedules and escalation where necessary.
- Ensure completeness of required documentation such as insurance certificates, indemnification letters, and informed consent-related materials.
- 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.
- Opportunity to contribute directly to global clinical trials that support 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 and mission-driven environment centered on improving patient outcomes.
- Opportunity to build deep expertise in site contracting and clinical operations.