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Title: International Lead CRA - Clinical LeadCompany: BiotechnologyLocation: Hybrid - LeidenPlanet Pharma is partnered with a rapidly growing biotech company in Leiden that is transforming the rare disease landscape. As part of their expansion, they are hiring for an International Clinical Lead (Lead CRA) to manage complex, global clinical trials in rare disease indications.Main Responsibilities:Lead and coordinate the execution of global clinical trials within the rare disease space.Oversee clinical trial sites and ensure effective performance and compliance across all trial locations.Provide strategic leadership and operational oversight to CROs and third-party vendors.Drive site selection, start-up, enrollment, and monitoring activities in collaboration with internal and external stakeholders.Ensure alignment with regulatory requirements, internal SOPs, and GCP standards.Serve as the main point of contact for study progress, issue resolution, and risk mitigation across global trial teams.Collaborate closely with cross-functional teams including regulatory, data management, and clinical operations.Contribute to continuous improvement of clinical trial processes, systems, and vendor relationships.Main Requirements:Proven experience as a Lead CRA, Clinical Lead, or Clinical Trial Manager (CTM) within the biotech industry.Extensive background in rare disease clinical trials.Strong SME biotech experience is essential.Demonstrated expertise in CRO and vendor oversight, including performance management of site monitoring teams.In-depth knowledge of ICH-GCP, global regulatory requirements, and clinical development processes.Ability to thrive in a fast-paced, agile biotech environment with a proactive and solution-oriented mindset.Strong leadership, communication, and cross-cultural collaboration skills.Interested? Apply now for immediate consideration or contact Maria Tsalpatourou at PLANET PHARMAPlanet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.We are an equal opportunities Recruitment Business and Agency.We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.