Overview
This role supports timely negotiation, execution, and management of clinical trial agreements, budgets, and related documentation to enable efficient study start-up and site activation. The position collaborates with sponsors, investigative sites, legal teams, and internal study start-up stakeholders to ensure contracts are delivered accurately, compliantly, and within agreed timelines.
Responsibilities
- Prepare, review, negotiate, and manage clinical trial agreements, amendments, and associated contract documentation.
- Develop, negotiate, and manage site budgets within approved sponsor parameters.
- Serve as a primary liaison between sponsors, investigative sites, legal teams, and internal stakeholders for contract and budget activities.
- Ensure contracts and budgets are executed within agreed study timelines and project milestones.
- Maintain contract management systems, trackers, templates, and documentation to support compliance and transparency.
- Review contractual documents to ensure accuracy, completeness, and alignment with applicable regulations, sponsor requirements, and organization policies.
- Monitor contract status and proactively identify and resolve negotiation roadblocks.
- Support site payment activities and coordinate accurate and timely invoicing processes.
- Assist with country and site start-up activities, including document collection and study maintenance as required.
- Ensure contract-related documentation is appropriately filed and maintained throughout the study lifecycle.
- Participate in project meetings and provide updates on contract and budget progress.
- Support quality initiatives, audits, inspections, and process improvement activities.
- Contribute to the development of systems, tools, and best practices across contract and budget management functions.
Requirements
- Bachelor’s degree or equivalent qualification in a scientific, healthcare, legal, business, or related discipline.
- Previous experience within a CRO, pharmaceutical company, or clinical research environment.
- Proven experience in site contract negotiation and budget management for clinical trials.
- Strong understanding of clinical research processes, study start-up activities, and site activation requirements.
- Working knowledge of ICH-GCP guidelines and applicable regulatory requirements.
- Excellent negotiation, communication, and stakeholder management skills.
- Ability to review and interpret contractual, legal, financial, and operational documentation.
- Strong attention to detail with exceptional organizational and project coordination skills.
- Comfortable working with contract management systems, CTMS platforms, and Microsoft Office applications.
- Demonstrated ability to work independently while collaborating effectively within cross-functional teams.
- Proactive, solutions-focused mindset with the ability to manage competing priorities in a fast-paced environment.
Preferred Qualifications
- Experience working across multiple countries and cultures.
Compensation & Benefits
- Expected salary range: $75,000 - $110,000 per year, depending on experience and qualifications.
- Competitive compensation with a salary and benefits package aligned with skills and experience.
- Flexible working: remote or hybrid options depending on location and business requirements.
- Career development opportunities, including learning, mentorship, and global career pathways.
- Employee wellbeing initiatives designed to support work-life balance, health, and engagement.
Location
- Remote or hybrid working options are available depending on location and business requirements.