Clinical Site Manager (Study Start-up)

Roche • Pleasanton, CA

1d

About 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.

Requirements

• Bachelor's degree in Science Degree preferably in Health Sciences like Clinical Diagnostics or engineering (or equivalent combination of education and work experience)
• 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
• 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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level