Principal Specialist, Site Contracts

🔥 52 minutes ago

🇪🇸 Spain – Remote

⏰ Full Time

🔴 Lead

✨ Contracts Specialist

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Lead the preparation, negotiation, review, and finalization of Clinical Trial Agreements, associated documents, and site budgets • Act as a subject matter expert on country- and site-level contracting processes • Provide guidance on contracting strategies, timelines, requirements, budgets, and risks • Review study budgets and site costs, identify revisions, and support country budget and contract and budget plan development • Resolve complex negotiation issues, escalate requests outside approved parameters, identify contracting risks, and develop mitigation strategies • Perform quality reviews of contracts and budgets • Facilitate signature processes and distribute completed agreements to relevant stakeholders and systems • Partner with sites, investigators, legal, finance, data protection, clinical operations, and Site Contract Leads • Maintain accurate, real-time contract tracking while managing competing priorities, urgent requests, and multiple site agreements • Lead selected project-level activities, including investigator grant budget oversight, TMF structure reviews, site agreement processes, and communication of contracting strategies and timelines • Mentor and support team members • Contribute to SOPs, contract templates, and continuous improvement of site contracting processes

🎯 Requirements

• Bachelor’s degree or equivalent in business administration, finance, law, science, or a related field • 3–4 years of experience as a Senior Site Contracts Specialist or a minimum of 5 years of site contracting experience within the clinical research, pharmaceutical, or CRO industry • Excellent verbal and written English proficiency • Expert contract negotiation skills, including resolving complex issues and managing disputes • Strong knowledge of ICH and GCP guidelines • Knowledge of applicable local clinical trial legislation and regulatory requirements • Understanding of biopharmaceutical/CRO industry requirements • Strong understanding of clinical trial budgets, financial principles, contract terminology, and risk identification and mitigation • Leadership, collaboration, problem-solving, analytical, organizational, and time-management skills • Ability to mentor colleagues and work effectively with cross-functional teams • High attention to detail and accuracy when drafting and reviewing contracts, budgets, and related documentation • Proficiency with MS Word, Excel, Outlook, and contract management tools • Candidates must be based in Spain

🏖️ Benefits

• Collaborative and inclusive work environment • Growth and career development opportunities • Mentoring and learning opportunities • Remote work arrangement • Opportunity to contribute to meaningful clinical research and life-changing therapies

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