Clinical Site Manager

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $90.9k - $142.8k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Roche

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1896

🏥 Healthcare

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Healthcare • Healthcare Insurance • Pharmaceuticals

Roche is at the forefront of technological advancements in healthcare. The company emphasizes the importance of diversity, equity, and inclusion across its global workforce of over 101,000 employees. Roche is particularly focused on research and development, digital innovation, and creating sustainable collaborations to benefit patients worldwide. With a strong culture of rewarding employee performance, Roche provides a diverse range of career opportunities in areas such as tech, manufacturing, and business strategy, encouraging innovation to transform global healthcare. The company also offers various programs for students and graduates, and operates in several countries, including Germany, Austria, and Switzerland.

📋 Description

• Design, plan, coordinate, and conduct activities involved in initiating clinical research studies at assigned sites • Lead end-to-end study start-up activities, including site identification, selection, and activation • Manage Ethics Committee (EC), Competent Authority (CA), and/or Institutional Review Board (IRB) submissions • Ensure trial documentation, local contracts, and institutional approvals meet regulatory timelines • Act as the primary contact and clinical trial expert for start-up activities for assigned study site personnel • Coordinate necessary certifications • Develop study documentation, including informed consent documents and patient instruction guides • Collaborate with global, local, and virtual teams to deliver clinical diagnostic solutions • Partner across diverse regions, cultures, and time zones to build inclusive team environments • Ensure studies are delivered, recorded, and reported according to protocols, standard operating procedures, and global regulatory guidelines

🎯 Requirements

• A degree in a scientific discipline or related field (or equivalent combination of education and experience) • Proven track record in clinical operations or clinical trial coordination • Hands-on experience navigating diagnostic and medical device trials • Experience managing Ethics Committee (EC) and Competent Authority (CA) regulatory submissions • Exceptional verbal and written communication skills in English • Ability to build trusted relationships and influence cross-functional partners • German speaking is a plus • Strong problem-solving skills • Ability to make sound independent decisions • Experience managing external vendor relationships • Ability to work in a fast-paced, matrixed environment • Flexibility and adaptability for fluid, cross-team collaboration

🏖️ Benefits

• A discretionary annual bonus may be available based on individual and Company performance • Benefits detailed at the provided link

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