Associate Director Clinical Trial Site Contracts And Budget

Overview

• Lead strategy and execution for clinical trial site contracts and budgets in a dynamic, remote role.
• Collaborate with cross-functional teams to ensure timely study start-up and compliance with corporate goals.
• Drive continuous improvement initiatives focused on efficiency and risk mitigation in contracting processes.
• Oversee vendor and CRO performance related to site contracting deliverables and adherence to milestones.
• Implement tools and systems to optimize contract lifecycle management and financial tracking.
• Provide insights and support for governance meetings and leadership decision-making.
• Ensure compliance with GCP, SOPs, and regulatory requirements in all contracting activities.
• Contribute to audit readiness and inspection activities as required.

Key Responsibilities & Duties

• Develop and implement global site contracting strategies aligned with clinical trial timelines.
• Negotiate Clinical Trial Agreements (CTAs), Confidential Disclosure Agreements (CDAs), and amendments.
• Lead development and negotiation of site budgets using FMV benchmarks and historical data.
• Ensure alignment with legal, compliance, and risk frameworks in all agreements.
• Analyze cost drivers and identify opportunities for savings and efficiency improvements.
• Manage CRO performance and ensure adherence to KPIs and SLAs.
• Collaborate with Finance to manage forecasting, accruals, and budget performance.
• Standardize templates, playbooks, and negotiation guidelines for contracting processes.

Job Requirements

• Bachelor’s degree in Life Sciences, Business, Finance, or related field required; advanced degree preferred.
• Minimum 8 years of experience in clinical trial contracting and budgeting within biotech, pharma, or CRO.
• Proven expertise in negotiating global CTAs and site budgets.
• Strong understanding of FMV methodologies and regulatory requirements.
• Advanced negotiation and influencing skills with strong financial acumen.
• Experience with systems such as CTMS, eTMF, and budgeting tools.
• Excellent stakeholder management and communication skills.
• Ability to manage multiple studies and priorities in a fast-paced environment.