Clinical Site Manager (Study Start Up / In Vitro Diagnostic Regulation)
Roche Sant 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 collaborate across global, local, and virtual teams to support IVDR-compliant clinical studies and provide expert guidance at assigned sites.The position sits within Roche Diagnostics Solutions’ CDMA, contributing to faster, high-quality clinical evidence generation. You will influence study execution through training, governance, and cross-functional partnership.
Compensaciones / Beneficios- Lead end-to-end study start-up activities including site selection, activation, and qualification assessments
- Manage Ethics Committee (EC) and Competent Authority (CA) submissions ensuring regulatory compliance
- Provide CRO oversight, monitor external partner deliverables, track milestones, and escalate issues
- Serve as primary contact for assigned study site personnel, support study execution and training
- Develop critical study documents (informed consent, patient guides, EC/CA submission documents)
- Collaborate cross-functionally with global/local/virtual teams to achieve business goals and operational excellence
- Degree in a scientific discipline or related field (or equivalent experience) + proven track record in clinical operations or trial coordination
- Hands-on experience with EC and CA regulatory submissions
- Experience in CRO oversight and monitoring external partner deliverables
- Understanding of IVDR frameworks and global standards (ICH-GCP)
- Strong verbal and written communication skills in English
- Ability to build trusted cross-functional relationships and influence stakeholders
- Nice to have: German-speaking skills
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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 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...
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...