Clinical Site Manager
1 day ago
Vallés
Job OverviewThe Position As a Clinical Site Manager for the Study Delivery Near Patient Care CVMD team, you are designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies at the clinical study sites. You are responsible for delivering other data generation methodologies and ensuring that studies are delivered, recorded, and reported in accordance with protocol, standard operating procedures, good clinical practices, and other applicable regulatory requirements.Responsibilities- Act as the primary contact and clinical trial expert for assigned study site personnel, coordinating training, certification, and providing technical assistance to ensure successful study execution.- Perform site assessments and qualification visits to support the site selection decision process and site activation activities, including contracting and obtaining IRB/EC/Health Authority approvals in compliance with regulatory requirements.- Develop and manage key study site documentation, such as Study Monitoring Plans, informed consent documents, source documents, patient instruction guides, and case report forms, while contributing technical expertise to review study protocols, data management plans, reports, and manuscripts.- Oversee CROs for the delivery of site management activities, including training CRO CRAs, escalating issues, and collaborating with international investigators and key customers while mentoring and supporting colleagues to enhance their skills and expertise.- Execute site management activities for sponsored studies in assigned focus areas across all phases of study (start‑up, conduct, and close‑out) for both registrational and non‑registrational purposes.- Validate product performance claims, supply data for critical regulatory submissions, define the functional and clinical utility of products, and gather feedback and opinions from laboratories or customers regarding the products.- Work in local and global study teams, including virtual teams, demonstrating diversity, cultural awareness, and fostering strong, collaborative relationships with cross‑functional team members, internal stakeholders, and external partners to achieve business goals and ensure operational excellence.Qualifications- Bachelor’s degree in Science, preferably in Health Sciences such as Clinical Diagnostics or Engineering, or an equivalent combination of education and work experience.- 3 years of experience in the Medical Device or Diagnostics industry and 2 years of experience in clinical studies of IVD/Medical Device/Drug.- Experience in the cardiovascular/metabolic indication and Near Patient Care or Point of Care settings.- Experience with studies conducted in an emergency department setting is a plus.- Excellent understanding of ICH GCP guidelines in the execution of clinical trials.- Demonstrates the ability to make sound decisions, analyze and solve problems, take independent choices, and assume responsibility.- Shows flexibility and adaptability to perform in a fast‑paced, matrixed environment where fluid cross‑team collaboration is crucial.- Primary location: Sant Cugat del Vallès.Equal Opportunity StatementRoche is an Equal Opportunity Employer.#J-18808-Ljbffr
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