16 sep
|
Roche
|
San Cugat del Vallés
16 sep
Roche
San Cugat del Vallés
At Roche you can show up as yourself, embraced for the unique qualities you bring. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. As a Clinical Site Manager specialising in IVDR and Study Start-Up, you will be responsible for designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies at assigned sites.
You will work independently to ensure studies are delivered, recorded, and reported in accordance with protocols, standard operating procedures, and global regulatory guidelines. Lead end-to-end study start-up activities, driving site selection, activation, and qualification assessments to ensure clinical trials launch efficiently and are compliance-ready Manage Ethics Committee (EC) and Competent Authority (CA) submissions, ensuring all trial documentation is available, local contracts, Ethics Committee and Competent Authority approvals meet stringent regulatory requirements Provide robust CRO oversight, monitoring external partner deliverables, tracking milestones, and escalation of any issues. Act as the primary contact and clinical trial expert for assigned study site personnel, for execution of the study - including training and coordinating certification of study site personnel, and provide technical assistance, as necessary Collaborate cross-functionally with global,
local, and 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 Validate product performance claims, supply data for critical regulatory submissions, define the functional and clinical utility of our products, and obtain the opinions and input regarding our products from laboratories or customers Work in local and global study teams, including virtual teams and exhibit diversity and cultural awareness Bachelors Degree in scientific discipline or related field required, or equivalent combination of education and work experience, experience in a clinical laboratory, clinical study coordination is a plus Provides informal guidance to new team members Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come.
Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a general impact.
📌 Clinical Site Manager (San Cugat del Vallés)
🏢 Roche
📍 San Cugat del Vallés