Clinical Site Manager (Systems and Automation)

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 CVMD Core Lab SWA Systems & Automation team, you are designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies in 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

_This position's main location is Pleaseanton, but people from any part of the US are encouraged to apply._

• 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.
• Participating in and overseeing CRO delivery of site management activities, including training CRO CRAs, escalating issues, and collaborating with international investigators and key customers while mentoring and supporting colleagues to enhance their skills and expertise.
• Validating product performance claims, supplying data for critical regulatory submissions, defining the functional and clinical utility of products, and gathering feedback and opinions from laboratories or customers regarding the products.
• Executing site management activities for sponsored studies in assigned focus areas across all phases of study (start-up, conduct, and close-out) for both registrational and non-registrational purposes.
• Working in local and global study teams, including 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.

Who You Are

• You bring a Bachelor's degree in Science Degree preferably in Health Sciences like Clinical Diagnostics or engineering (or equivalent combination of education and work experience)
• You have 3 years of working experience in either the Medical Device or Diagnostics industry, and 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

Behaviors, competencies, and qualities of the ideal applicant.

• Exhibits the ability to make sound decisions and to analyze and solve problems; makes independent choices and takes responsibility
• Demonstrates flexibility and adaptability to perform in a fast-paced, matrixed environment where fluid, cross-team collaboration is crucial.

Relocation benefits are not offered for this position.

The expected salary range for this position based on the primary location of California is 90,900 - 150,480 USD annually. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits (https://roche.ehr.com/default.ashx?CLASSNAME=splash)

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Pleasanton. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.

Who we are

A healthier future drives us to innovate. 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 global impact.

Let's build a healthier future, together.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (https://docs.google.com/forms/d/e/1FAIpQLSdZWlsbfQOvFVIQgHE\_iDzWUTlhZvj6FytIzjS7xq6IGh1H5g/viewform) .