Job Description

Sr Clinical Study Manager

Hybrid in Sunnyvale, CA

12+ Month Contract (No C2C Available)

Job Summary:

Our client, a leader in robotic-assisted surgery, is seeking a Sr. Clinical Study Manager to lead the planning and execution of clinical studies that support regulatory approvals and key research initiatives. This role involves managing all aspects of clinical trials (pre- and post-market), including protocol development, site management, monitoring, and data analysis.

Key Responsibilities:

• Design and manage clinical and outcomes research studies
• Lead protocol development and study planning activities
• Oversee site selection, startup, monitoring, and closeout
• Ensure trials are conducted on schedule, within budget, and in compliance with regulations
• Collaborate with CRAs, CTAs, vendors, and internal teams
• Review data, write study reports, and support regulatory submissions
• Mentor junior study managers and guide monitoring activities
• Perform literature reviews to support study design and clinical strategies
• Work with commercial groups on post-market research
• Contribute to scientific publications and conference materials

Requirements:

Experience:

• 8+ years in clinical research (or equivalent based on education)
• Strong background in medical device trials and clinical study design
• Experience with protocol development, informed consents, and regulatory documentation
• Skilled in site management, clinical monitoring, and vendor coordination
• Strong communication, organizational, and leadership skills
• Ability to manage multiple priorities and travel 25–40%

Education:

• Bachelor’s degree in a scientific or engineering field required
• Advanced degree (M.S., Ph.D., or M.D.) preferred

Preferred:

• Experience in hospital or surgical settings
• Familiarity with statistics, outcomes research, and data analysis

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