Senior Clinical Site Contracting Consultant, MedTech

We are seeking a Senior Clinical Site Contracting Consultant, MedTech to serve as a senior strategic point of contact for site contract template development, clinical site contract negotiations, escalation management, and contract execution across European medical device clinical studies. This individual will bring deep expertise in site contracting, clinical trial agreements, and stakeholder management, partnering with sponsors, hospitals, health systems, and investigative sites to support study start-up and trial execution. The successful candidate will provide oversight on site agreement and budget development based on country requirements, resolve escalated contracting challenges, and provide strategic guidance on site agreement development and execution while ensuring alignment with study timelines, regulatory requirements, and business objectives. This role requires a strong understanding of the differing country contracting requirements across Europe and unique contracting considerations associated with medical device clinical research, including pre-market studies, post-market clinical follow-up (PMCF) activities, and investigations conducted under the European Medical Device Regulation (EU MDR). Key Responsibilities Serve as the senior escalation point for complex clinical site contract negotiations across European medical device studies. Develop and maintain clinical site contract templates, country budget templates, fallback language, negotiation playbooks, and country-specific contracting guidance. Provide strategic contracting support for medical device clinical investigations, PMCF studies, registries, and other evidence-generation activities. Partner with clinical operations, legal, regulatory, study start-up, finance, and procurement stakeholders to resolve contract-related issues and accelerate site activation timelines. Advise project teams on contract risk mitigation, negotiation strategy, and country-specific contracting challenges. Manage escalations involving indemnification, subject injury, intellectual property, publication rights, data privacy, confidentiality, payment terms, and device-specific contractual provisions. Ensure contracts comply with applicable regulatory requirements, including EU MDR, GDPR, and local country regulations. Support on the ground clinical research associates through day to day negotiations and provide subject matter expertise to internal and external teams. Qualifications Bachelor's degree required; advanced degree or legal background preferred. 5+ years of experience in European clinical site contracting, clinical trial agreements, study start-up, or contract negotiation within the medical device, MedTech, CRO, or life sciences industry . Demonstrated experience negotiating contracts directly with hospitals, healthcare systems, academic medical centers, and investigative sites across Europe. Strong knowledge of European clinical trial and medical device clinical investigation contracting practices. Experience supporting clinical investigations conducted under EU MDR and/or ISO 14155 preferred. Proven expertise in contract template development, clause negotiation, and escalation management. Experience collaborating with sponsors, CROs, legal departments, and clinical operations teams in a global environment. Strong understanding of GDPR and data privacy considerations in clinical research. Exceptional communication, negotiation, stakeholder management, and problem-solving skills. Ability to manage multiple studies and priorities within a fast-paced consulting environment. Preferred Experience Experience supporting European medical device clinical trials, clinical investigations, PMCF studies, registries, or real-world evidence programs . Bilingual in English, Dutch, French, Italian, or Spanish is preferred. Experience within a MedTech CRO, sponsor organization, or strategic consulting environment. Knowledge of EU MDR requirements and device development lifecycle. Experience supporting multinational European studies across multiple therapeutic and device categories. Familiarity with CTMS, eTMF, and contract management systems. Location: This role may be based remotely in Germany, France, Italy, Spain, or the Netherlands . The consultant will support medical device clinical trial site contracting activities across Europe and work closely with sponsors, CROs, legal stakeholders, and investigative sites in a multi-country environment.