Clinical Trial Manager
hace 4 días
Madrid
Clinical Trial Manager 📍 Madrid, Spain Join Crovelis, an Insud Pharma company, and be part of a team shaping the future of clinical research through innovation, scientific expertise, and technology. About Crovelis & Insud Pharma Crovelis is part of Insud Pharma, a global pharmaceutical group with more than 45 years of experience in healthcare, committed to improving people’s lives through innovation, scientific excellence, and sustainable growth. As a specialized clinical research company within the Insud Pharma ecosystem, Crovelis combines deep expertise in clinical development with innovative approaches and technology to support the successful execution of clinical trials and accelerate the development of new therapies. Being part of Insud Pharma provides Crovelis with the strength, experience, and global perspective of a leading pharmaceutical group operating across the entire value chain, including research and development, manufacturing, and commercialization of healthcare solutions. Insud Pharma has a global presence with more than 10,000 professionals across more than 50 countries, supported by a network of industrial facilities, R&D centers, and commercial operations worldwide. The Opportunity 🔎 We are looking for a Clinical Trial Manager to join Crovelis’ Clinical Operations team in Madrid. In this role, you will play a key role in the operational management and oversight of clinical trials, ensuring studies are delivered according to quality standards, timelines, regulatory requirements, and project objectives. You will collaborate with internal teams, sponsors, CRO partners, investigators, vendors, and clinical sites, contributing to the successful execution of clinical programs from study start-up through close-out. Key Responsibilities Clinical Trial Management & Oversight • Manage and oversee clinical trial activities throughout the study lifecycle., • Collaborate with Clinical Operations teams, sponsors, CROs, and external partners to ensure study milestones are achieved., • Develop and review essential study documents, including Informed Consent Forms, Clinical Monitoring Plans, and study-related materials., • Lead study team meetings and CRA meetings, ensuring effective communication and alignment among stakeholders., • Ensure study teams and sites are appropriately trained on protocols, processes, and documentation., • Act as a point of contact for protocol-related questions and operational escalations., • Ensure Trial Master File (TMF) quality, completeness, and compliance throughout the study., • Support inspection readiness activities and compliance with ICH-GCP and applicable regulations. Study Performance & Vendor Management • Provide oversight, guidance, and support to CRAs and clinical research teams., • Monitor study timelines, risks, deliverables, and key milestones., • Collaborate with vendors to ensure quality execution and delivery of study activities., • Contribute to continuous improvement initiatives within Clinical Operations. Budget & Financial Oversight • Support study budget management and operational forecasting., • Monitor site and vendor payments., • Review clinical invoices and ensure alignment with approved scopes of work. What are we looking for? 🎯 • Bachelor’s degree or equivalent in Life Sciences, Health Sciences, Pharmacy, Nursing, or related field., • Master’s degree or additional clinical research training is a plus., • Minimum 4 years of experience in clinical research, including clinical monitoring and clinical trial management., • Experience working within a CRO and/or pharmaceutical sponsor environment., • Strong knowledge of clinical research processes, ICH-GCP guidelines, regulatory requirements, and clinical development., • Experience managing clinical studies across different phases and therapeutic areas., • Strong organizational, communication, and stakeholder management skills., • Fluent English is required. Why join Crovelis? 🚀 Joining Crovelis means becoming part of Insud Pharma, a global pharmaceutical group where science, innovation, and patient impact are at the center of everything we do. You will have the opportunity to work in a dynamic clinical development environment, collaborate with international experts, and contribute to bringing new healthcare solutions to patients worldwide.
75 Calle de Francisco Silvela, Lista, 28028, Madrid
