05 oct
|
Jobrapido
|
La Granja de la Costera
05 oct
Jobrapido
La Granja de la Costera
Overview In this role, you drive end-to-end study start-up for clinical trials at designated sites, ensuring compliant launch and ongoing execution. You will liaise with cross-functional teams to secure EC/CA approvals, prepare key study documents, and act as the primary start-up expert for site personnel. You’ll foster inclusive, cross-regional collaboration while converting regulatory requirements into actionable, timely study activities. This position shapes efficient, compliant trial initiation within Roche’s mission to improve global health. Responsabilidades Lead end-to-end study start-up activities, including site identification, selection, and activation Manage Ethics Committee (EC) and Competent Authority (CA) submissions to meet regulatory timelines Serve as primary contact for start-up activities for assigned study site personnel Develop essential study documents (informed consent,
patient guidance) Collaborate with global/local/virtual teams to deliver clinical diagnostic solutions Foster inclusive team environments across regions and time zones Requisitos principales Degree in a scientific discipline or related field (or equivalent experience) Proven track record in clinical operations or clinical trial coordination Hands-on experience with EC and CA regulatory submissions Strong understanding of IVD/MDR frameworks and integral standards (ICH-GCP) Exceptional verbal and written communication (English) and ability to influence cross-functional partners proactive collaborative highly organized EC/CA submissions for diagnostic trials IVD/MDR knowledge ICH-GCP familiarity
📌 Clinical Site Manager (Study Start Up For Npc - German Speaking) (La Granja de la Costera)
🏢 Jobrapido
📍 La Granja de la Costera