Site Specialist - Contracts & Budgets
Core
Leading negotiation, execution, and management of Clinical Trial Agreements (CTAs) and site budgets with investigative sites to ensure timely clinical trial start-up and regulatory compliance.
Role type
Senior IC contracts specialist (clinical trials)
Builds
Clinical trial agreements and site budgets for global clinical studies
Domain
Healthcare / Clinical Research / CRO
Required skills
Clinical Trial Agreement negotiation, site budget management, regulatory compliance knowledge, contract execution, risk mitigation, cross-functional collaboration, stakeholder communication, process improvement, mentoring junior staff, strategic insights
Preferred skills
Experience in pharmaceutical/biotech/CRO environment, understanding of local laws and regulatory requirements across jurisdictions, ability to manage multiple priorities in fast-paced environments
Technologies
Contract databases, submission packages for EC/IRB and Competent Authorities
Responsibilities
Negotiate and manage CTAs and site budgets with investigative sites; Collaborate with Clinical Operations and Project Management for site activation; Partner with Functional Management on regulatory adherence; Support study start-up including translation coordination and submission packages; Review and evaluate contract changes and deviations; Manage multiple contracts simultaneously; Identify and escalate risks; Ensure contract completeness and filing; Mentor junior Contract Associates; Provide strategic insights to management
Seniority
Mid-Senior, hands-on IC with mentoring responsibilities