Our client, a leading global biopharmaceutical organization, is seeking an experienced Regional Contracts Lead to oversee and drive the on-time execution of all regional clinical contract agreements. This role plays a critical part in ensuring effective site engagement, timely study start-up, and operational excellence across multiple therapeutic areas. About the Role The Regional Contracts Lead will be responsible for managing the end-to-end lifecycle of clinical site contracts, including Clinical Trial Agreements (CTAs), investigator agreements, confidentiality agreements, pharmacy agreements, site master service agreements, consulting agreements, and other contract types. This position will provide regional oversight, serve as the escalation point for contracting matters, and ensure contract negotiations align with fair market value, internal guidelines, and regulatory requirements. Key Responsibilities Provide functional line management to the regional Clinical Contracts team (Contract Managers and Associates), delivering feedback and supporting professional development. Ensure contract negotiation processes are efficient, consistent, and aligned with financial and operational needs. Oversee the negotiation of clinical site budgets, ensuring compliance with Fair Market Value and internal approval processes. Partner with Clinical Operations and CBO colleagues to improve contracting and budgeting metrics across portfolios. Apply consistent standards and processes across Therapeutic Areas and support continuous improvement initiatives. Serve as the primary regional escalation point for clinical site contracts and provide oversight at program level. Monitor and mitigate contracting risks, delays, and performance gaps, ensuring timely execution across regions. Provide insights leveraging industry data tools to ensure contract and budget decisions meet both company parameters and FMV guidance. Develop and implement new policies and procedures to enhance contracting practices. Maintain a strong compliance mindset, ensuring alignment with ICH-GCP, regulatory guidelines, and company standards. Qualifications & Experience Bachelor’s degree required; 8 years’ experience managing and negotiating Clinical Trial Agreements and budgets in the CRO or pharmaceutical industry. Deep knowledge of ICH-GCP, clinical trial contracting processes, and pharmaceutical regulations. Proven experience leading negotiations with clinical sites and stakeholders, with a strong understanding of intellectual property, indemnification, and publication issues in site contracts. Strong organizational and planning skills, with the ability to manage competing priorities in a fast-paced environment. Excellent communication, problem-solving, and conflict-resolution skills with fluency in English (and local language, if applicable). Proficiency in Microsoft Office, CTMS, Contract Lifecycle Management systems, Veeva, Jira, and SharePoint. Demonstrated leadership and ability to influence effectively at all levels of an organization. What We Offer The opportunity to play a pivotal role in accelerating clinical development and patient access to innovative medicines. A collaborative, dynamic environment where your expertise in contracts and negotiation will have a direct impact on global clinical trial success. Competitive compensation and benefits. If you are a proactive leader with proven experience in clinical site contract negotiations and a strong track record of operational excellence, we invite you to apply for this exciting opportunity. Apply Now to join a global leader in clinical research and shape the future of medicine.
