Roche
ClinicalSiteManager
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“Clinical Site Manager at Roche. Designing, planning, coordinating, and conducting clinical research studies. Delivering other data generation methodologies”
What You'll Achieve.
ensure studies are delivered, recorded, and reported in accordance with protocol, standard operating procedures, good clinical practices, and other applicable regulatory requirements; ensure successful study execution; achieve business goals and ensure operational excellence
Industry & Context.
analyze and solve makes independent choices and takes responsibility
What They're Looking For.
Must Have
3 years of working experience in either the Medical Device or Diagnostics industry, 2 years of working experience in clinical study of IVD/Medical Device/Drug, Excellent understanding of ICH GCP guidelines in the execution of clinical trials
Nice to Have
Experience with studies in an emergency department setting is a plus
What You'll Do.
and conducting clinical research studies
Delivering other data generation methodologies
Working independently to ensure studies are delivered
Acting as the primary contact and clinical trial expert
Coordinating training
and providing technical assistance
Performing site assessments and qualification visits
Developing and managing key study site documentation
Contributing technical expertise to review study protocols
Overseeing CROs for the delivery of site management activities
Executing site management activities for sponsored studies
Validating product performance claims
Supplying data for critical regulatory submissions
Defining the functional and clinical utility of products
Gathering feedback and opinions from laboratories or customers
How You'll Work.
Team & Collaboration
Collaborating with international investigators and key customers; Working in local and global study teams, including virtual teams; Fostering strong, collaborative relationships with cross-functional team members, internal stakeholders, and external partners
Full Job Description
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. ### ### The 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 delivering other data generation methodologies, working independently to ensure studies are delivered, recorded, and reported in accordance with protocol, standard operating procedures, good clinical practices, and other applicable regulatory requirements. **The Opportunity** Acting 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. * Performing 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. * Developing and managing 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. * Overseeing 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
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