Lead Clinical Site Manager (Study Start Up / In Vitro Diagnostic Regulation)
Roche Sant Cugat del Vallès
Experteer Overview
In this Lead Clinical Site Manager role, you design and drive start-up, monitoring, and completion of clinical studies within Roche Diagnostics Solutions. You will oversee regulatory submissions, site activation, and vendor oversight to ensure compliant, timely trials.You’ll collaborate across global teams to deliver robust clinical evidence supporting product adoption and regulatory success. This is an opportunity to shape how studies are launched and executed in a patient-focused, cross-functional environment.
Compensaciones / Beneficios- Lead end-to-end study start-up activities including site selection, activation, and qualification assessments
- Manage Ethics Committee and Competent Authority submissions to meet regulatory timelines
- Provide CRO oversight, monitor external partner deliverables, and ensure alignment with Roche quality standards
- Serve as primary clinical trial expert for site personnel, providing training and coordinating necessary certifications
- Develop critical study documentation (e.g., Study Monitoring Plans, informed consent, case report forms)
- Conduct site monitoring and data validation activities across all study phases
- Collaborate with global, local, and virtual teams across R&D, Study Management, and Biometrics
- Lead, coach, and mentor colleagues to build team capabilities
- Degree in a scientific discipline or related field (or equivalent experience)
- Direct experience in Clinical Operations with EC/CA regulatory submissions
- Vendor management experience with CRO oversight and milestone tracking
- Strong understanding of IVDR and MDR frameworks, plus ICH-GCP and FDA regulations
- Excellent verbal and written communication in English with ability to influence cross-functional partners
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Page PersonnelBarcelona, 8 km de Sant Cugat del Vallès
Lead Engineer/CTO - StartUp
Perfil buscado (Hombre/Mujer)
Liderar técnicamente el desarrollo y la evolución de una plataforma tecnológica orientada a la protección de información sensible en entornos de inteligencia artificial.
Definir...
RocheSant Cugat del Vallès
Experteer Overview
In this role, you will lead end-to-end study start-up and site activation, ensure regulatory submissions and documentation meet stringent standards, and oversee external partners to drive compliant trial delivery. You will...
NovartisBarcelona, 8 km de Sant Cugat del Vallès
Experteer Overview
In this role, you drive end-to-end Study Start-Up performance across a global, highly matrixed portfolio. You lead a cross-functional SSU team to balance speed, quality, and risk, ensuring timely readiness for site activation...