Roche
ClinicalSiteManager
Neural analysis suggests this role is
optimal for Mid candidates.
“Clinical Site Manager at Roche. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. designing, planning, coordinating and conducting all activities involved in initiating, monitoring, and completing clinical research studies in the clinical study sites and delivering as appropriate other data generation methodologies.. Work independently to ensure studies are delivered, recorded and reported in ”
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.; meeting business goals; ensuring operational excellence.
What They're Looking For.
Must Have
Bachelor’s degree in a scientific discipline, 3 years of experience in a regulated, CRO, diagnostic and or pharmaceutical industry, Adhere to regulations, guidelines and standard operating procedures, and ensure ongoing audit/inspection readiness., Prior experience with clinical trial management and bio-sample (clinical testing) management and quality assurance, Prior experience validating product performance claims, supplying data for critical Regulatory submissions, defining the functional and clinical utility of our products, and obtaining the opinions and input regarding our products from laboratories or customers., Executed Site Management activities for sponsored studies for assigned areas of focus for registrational and/or non-registrational purposes through all study phases (start-up, conduct and close-out)., Worked in local and global study teams, including virtual teams and exhibit diversity and cultural awareness., Built and maintained strong, collaborative relationships with cross-functional team members, relevant internal and external stakeholders, in meeting business goals and ensuring operational excellence.
Nice to Have
Experience working in a clinical laboratory environment or clinical lab study, Experience in In Vitro Diagnostics (IVD) and Clinical Research Associate (CRA) operations., Experience with Ultra/Ultra Plus instrumentation and complex data transfer protocols., Prior experience within Companion Diagnostics
What You'll Do.
designing, planning, coordinating and conducting all activities involved in initiating, monitoring, and completing clinical research studies in the clinical study sites and delivering as appropriate other data generation methodologies., Work independently to ensure studies are delivered, recorded and reported in accordance with protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements., Act as 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 providing technical assistance, as necessary., Perform site assessments/site qualification visits in the site selection decision process., May participate in and ensure site activation (contracting, IRB/EC/Health Authority approvals are, etc.
) are properly obtained, maintained and meet regulatory requirements in collaboration with relevant RDS Functions prior to initiation of the investigational site., Develop key study site documents (e.
Study Monitoring Plan, informed consent documents, source documents, patient instruction guides and case report forms, etc.
) and contribute technical expertise in the review of study protocols, data management plans, reports and manuscript, etc., Deliver all data generation/validation and site monitoring activities including end-to-end site visits per relevant regulations and processes., May participate in the oversight of CRO delivery of Site Management activities, including training of CRO CRAs.
This includes escalation of any issues., Accountable for site-level budget of assigned sites.
How You'll Work.
Team & Collaboration
Collaborate cross-functionally with R&D, Field Service, Study Management, Biometrics, etc. to deliver best solutions.; Worked in local and global study teams, including virtual teams and exhibit diversity and cultural awareness.; Built and maintained strong, collaborative relationships with cross-functional team members, relevant internal and external stakeholders, in meeting business goals and ensuring operational excellence.
Communication Scope
open dialogue
Process & Methodology
clinical trial management, Site Management activities, operational excellence
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 A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. The Clinical Site Manager is responsible for designing, planning, coordinating and conducting all activities involved in initiating, monitoring, and completing clinical research studies in the clinical study sites and delivering as appropriate other data generation methodologies. Work 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:**** * Act as 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 providing technical assistance, as necessary. * Perform site assessments/site qualification visits in the site selection decision process. * May participate in and ensure site activation (contracting, IRB/EC/Health Authority approvals are, etc.) are properly obtained, maintained and meet regulatory requirements in collaboration with relevant RDS Functions prior to initiation of the investigational site. * Develop key study site documents (e.g. Study Monitoring Plan, informed consent documents, source documents, patient instruction gu
Applying for this Clinical Site Manager role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Roche?
Real rants from real employees. Read before you apply.