Clinical Research Associate

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 Study Start-up Team, you are responsible for start-up activities for the assigned studies. You manage the end-to-end start-up process for clinical research sites using data-driven approaches to identify sites, regulatory submissions, contract negotiations, and essential document collection to ensure site readiness. You will act as a critical liaison between study teams, legal, privacy, CROs, and external sites to speed study start. You ensure all activities comply with global GCP, Global Standard procedures, and local regulatory requirements for high-quality study delivery.

The Opportunity

• Delivering high-quality and timely global study start-up by providing guidance and oversight to site activation specialists for initial activities, monitoring progress, and ensuring compliance with regulatory timelines and requirements.
• Understanding global regulatory, IRB, and ethics committee submission processes, coordinating submissions when needed, facilitating document translations for approvals, and supporting clinical trial insurance processes to meet study requirements.
• Coordinating contract and budget negotiations with sites and internal teams, managing investigational product release authorizations, and ensuring purchase orders and Fair Market Value assessments are completed to enable timely study start-up.
• Supporting study instrument placements, obtaining import/export approvals, and overseeing the implementation and use of eTools at sites to ensure operational efficiency during clinical trials.
• Participating in internal audits and external inspections, contributing to corrective and preventive actions (CAPAs) as required, and driving continuous improvement activities for essential document-related tasks and processes.
• Leading site identification and selection activities, collaborating across teams to ensure appropriate site partnerships are established for study success.

Who You Are

• Bachelor's Degree scientific discipline or related field OR equivalent combination of education and work experience. Medical technology or similar experience is a plus
• 1 year of experience in clinical trials, preferably study start-up, is required
• Knowledge and understanding of ICH/GCP and global regulatory guidelines/directives
• Experience in leading Sponsor and Site-related essential documents, including the use of CTMS for Site Creation & management, eTMF,  Sponsor vs. Site requirements
• Familiarity in engaging with and coordinating third-party service providers (CROs, Labs, etc.)

Behaviors, competencies, and qualities of the ideal applicant.

• Strong analytical skills and attention to detail; handling ambiguity; making decisions under minimal guidance
• Anticipate business needs, good organizational skills and prioritization, underrstanding that the job that have a significant impact on the organization’s financial and business operations. Good understanding of study financial management.
• Participate and work effectively on multiple cross-functional teams. Lead initiatives to implement change in the organization when needed
• Good communication and interpersonal skills.

Relocation Benefits are not offered for this job posting.

 

The expected salary range for this position based on the primary location of Pleasanton is 62,100 - 91,200 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

 

 

 

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.