This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Site Contracts Associate based in India.
This role offers an opportunity to lead and manage complex clinical site contracting activities within a global research environment.
You will support clinical trial operations by negotiating agreements, ensuring regulatory compliance, and enabling successful study execution.
The position focuses on contract strategy, stakeholder collaboration, risk management, and maintaining high-quality documentation standards.
You will act as a key partner between clinical sites, internal teams, and external stakeholders to facilitate efficient contract execution.
This opportunity provides exposure to international clinical research operations, regulatory frameworks, and strategic process improvements.
The ideal candidate will bring strong contract expertise, negotiation skills, and the ability to manage complex projects in a global setting.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Site Contracts Associate based in India.
This role offers an opportunity to lead and manage complex clinical site contracting activities within a global research environment.
You will support clinical trial operations by negotiating agreements, ensuring regulatory compliance, and enabling successful study execution.
The position focuses on contract strategy, stakeholder collaboration, risk management, and maintaining high-quality documentation standards.
You will act as a key partner between clinical sites, internal teams, and external stakeholders to facilitate efficient contract execution.
This opportunity provides exposure to international clinical research operations, regulatory frameworks, and strategic process improvements.
The ideal candidate will bring strong contract expertise, negotiation skills, and the ability to manage complex projects in a global setting.
Accountabilities:
- Draft, review, negotiate, and manage clinical site agreements, service agreements, team member agreements, and related contractual documents.
- Analyze contract comments and provide context based on local legal requirements, business practices, and negotiation experience.
- Review agreements and revisions against approved negotiation strategies, budget parameters, and project requirements.
- Ensure contracts comply with applicable laws, regulations, guidelines, and clinical research standards including ICH-GCP.
- Protect the interests of all stakeholders by facilitating balanced and effective contract solutions.
- Serve as a key communication point between site contracting teams, clinical trial sites, internal stakeholders, and external partners.
- Manage the full contract execution process, including approvals, signatures, tracking, and timely completion.
- Maintain accurate contract records, documentation, and archival processes according to established guidelines.
- Build and maintain strong relationships with clinical trial sites and study teams.
- Develop a thorough understanding of study protocols, budgets, timelines, and operational requirements to ensure contract alignment.
- Identify contract risks, resolve issues proactively, and collaborate with stakeholders to develop effective solutions.
- Monitor contracting milestones, maintain accurate status reporting, and ensure timelines are achieved.
- Perform quality checks on contracts and documentation to ensure completeness, accuracy, and compliance.
- Identify and implement process improvements to increase efficiency and quality within contracting operations.
- Provide guidance and support to study teams and project management teams on site contracting matters.
- Mentor and train less experienced team members while supporting consistent quality standards.
- Maintain awareness of country-specific contracting trends, regulations, and industry practices.
- Support the development and improvement of site contracting strategies and operational processes.
- 8+ years of experience in site contracting, contract management, clinical research, CRO environments, or a related field.
- Bachelor’s degree in law, economics, business, social sciences, or another relevant discipline, or equivalent professional experience.
- Strong understanding of clinical trial agreements, contract processes, budgets, and regulatory requirements.
- Experience reviewing and interpreting complex legal language and contractual terms.
- Strong negotiation, diplomacy, and stakeholder management skills.
- Ability to manage multiple projects, priorities, and deadlines in a fast-paced environment.
- Excellent written and verbal communication skills in English; additional languages are beneficial.
- Strong analytical and problem-solving abilities with attention to detail.
- Ability to identify issues independently and implement effective solutions.
- Experience working with virtual teams and global stakeholders.
- Strong organizational skills and ability to maintain high-quality documentation.
- Proficiency with Microsoft Office applications, particularly Excel, Word, and PowerPoint.
- Ability to mentor junior team members and provide constructive guidance and feedback.
- Professional approach with the ability to remain effective under pressure.
- Strong understanding of quality standards, operational processes, and compliance requirements.
- Competitive salary package aligned with experience and contract management expertise.
- Opportunity to support global clinical research initiatives with meaningful healthcare impact.
- Exposure to international stakeholders, regulatory environments, and complex contracting projects.
- Professional growth opportunities through leadership, mentoring, and strategic responsibilities.
- Flexible remote working arrangement.
- Collaborative environment with global teams and cross-functional partners.
- Healthcare benefits and employee support programs.
- Opportunities to expand expertise in clinical operations, contract strategy, and regulatory compliance.
- Continuous learning opportunities within a science-driven and innovation-focused environment.
The Principal Site Contracts Associate will oversee site contracting activities, ensuring agreements are accurately prepared, negotiated, executed, and aligned with regulatory requirements and study objectives. The role requires strong ownership of contract processes, stakeholder communication, and quality-driven execution.
Requirements:
The ideal candidate will have extensive experience in clinical site contracting, contract negotiation, and global research operations, with strong communication and leadership capabilities.