Site Contracts Lead, Europe

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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

• Be the main point of contact for Project Team and Sponsor, for all Study site contracting activities, during the life of contracting on the Study. • Act as a Subject Matter Expert (SME) on Clinical Trial Agreement processes at country and site level. • Agrees and negotiates Clinical Trial Agreements templates, fall back language and sites budget negotiation parameters with Global Project Lead and Sponsor. • Supports, supervises, and mentors allocated Site Contracts Specialists, ensuring effective planning, effective communication, on time issues escalation, problem solving and execution. • Negotiation and finalization or assistance in negotiation and finalization of Site Contracts with Worldwide Legal Department, project team, Sponsors, investigators and/or clinical sites, as well as amending and terminating such contracts. • Accountable for maintaining the housing of all draft, finalized, and executed Study contracting documents within each Study Sharepoint. • Creates and delivers on-going departmental trainings on various topics provided by contract management team.

🎯 Requirements

• Up to 2 years of experience as a Principal Site Contracts Specialist and 2 – 3 years’ experience leading projects OR Minimum 6 years Site Contract experience in Clinical Research Pharmaceutical or CRO industry and 2 – 3 years’ experience leading projects. • Bachelor's Degree or equivalent in business administration, finance, science or related field. • Knowledge and understanding of ICH and GCP Guidelines, as well as local country legislation in the sphere of clinical trials and local regulatory requirements. • High degree of organizational, analytical, and team management skills. • Adept knowledge of biopharmaceutical/CRO industry and applicable local regulatory requirements.

🏖️ Benefits

• Professional development opportunities • Flexible working arrangements