Principal Specialist, Site Contracts

This is a fully remote position, open to applicants in Spain.

📋 Description

• Lead the development, negotiation, review, and finalization of Clinical Trial Agreements, related documents, and site budgets.

• Serve as a subject matter expert on contracting processes at both the country and site levels.

• Offer guidance on contracting strategies, timelines, requirements, budgets, and associated risks.

• Review study budgets and site expenses, pinpoint necessary revisions, and assist in the development of country budget and contract plans.

• Address complex negotiation challenges, escalate requests that fall outside approved parameters, identify contracting risks, and formulate mitigation strategies.

• Conduct quality reviews of contracts and budgets.

• Facilitate the signature processes and ensure completed agreements are distributed to relevant stakeholders and systems.

• Collaborate with sites, investigators, legal, finance, data protection, clinical operations, and Site Contract Leads.

• Maintain precise, real-time contract tracking while balancing competing priorities, urgent requests, and multiple site agreements.

• Lead specific project-level activities, including oversight of investigator grant budgets, reviews of TMF structures, site agreement processes, and the communication of contracting strategies and timelines.

• Mentor and provide support to team members.

• Contribute to the development of SOPs, contract templates, and the ongoing enhancement of site contracting processes.

⛳️ Requirements

• Bachelor's degree or equivalent in business administration, finance, law, science, or a related discipline.

• 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 sectors.

• Exceptional verbal and written proficiency in English.

• Advanced contract negotiation abilities, including the resolution of complex issues and management of disputes.

• Strong understanding of ICH and GCP guidelines.

• Familiarity with local clinical trial legislation and regulatory requirements.

• Knowledge of the requirements within the biopharmaceutical/CRO industry.

• Comprehensive understanding of clinical trial budgets, financial principles, contract terminology, and risk identification and mitigation.

• Possess leadership, collaboration, problem-solving, analytical, organizational, and time-management skills.

• Capability to mentor colleagues and collaborate effectively within cross-functional teams.

• High attention to detail and accuracy in drafting and reviewing contracts, budgets, and related documents.

• Proficiency in MS Word, Excel, Outlook, and contract management tools.

• Candidates must be located in Spain.

🏝️ Benefits

• Collaborative and inclusive work environment.

• Opportunities for growth and career development.

• Access to mentoring and learning opportunities.

• Flexible remote work arrangement.

• Chance to contribute to impactful clinical research and transformative therapies.