Clinical Affairs Manager

August 23

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $116.6k - $194.4k / year

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

🦅 H1B Visa Sponsor

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Dexcom

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Healthcare Insurance • Biotechnology • Wearable Technology

Dexcom is a leading provider of continuous glucose monitoring (CGM) systems, revolutionizing how people manage diabetes and track their glucose levels. Known for their best-in-class glucose biosensing technology, Dexcom offers products like the Dexcom G7 CGM system, which provides real-time glucose monitoring and insights to help individuals become healthier. Founded in 1999, Dexcom has consistently innovated in the field of diabetes management, empowering users to take control of their health with accurate and advanced glucose monitoring solutions. Their products are designed for both adults and children and do not require a prescription.

10,000+ employees

Founded 1999

⚕️ Healthcare Insurance

🧬 Biotechnology

📋 Description

• Lead a team of global direct reports responsible for comprehensive site management activities including site selection, qualification, activation, training, proctoring, communications, and closeout for clinical studies sponsored by Dexcom. • Direct management and development of personnel including hiring, mentoring, performance reviews, and remedial actions. • Drive development and improvement of clinical procedures, processes, and templates to support continuous quality improvement. • Oversee site identification, qualification, selection processes, SQVs, SIVs, COVs, and ensure site activation readiness. • Provide support for audits/inspections and ensure resolution of findings; maintain site-level and sponsor TMF for archiving. • Facilitate IRB/EC submissions and end-of-study notifications; oversee investigator site files and study manuals. • Develop and implement systems, frameworks, policies, and tools to support data-driven decision-making across programs. • Provide strategic direction as a subject matter expert in site management; develop and report team performance metrics. • Lead Site Managers to facilitate training on study-specific equipment and ensure proper use and adherence to the Clinical Investigation Plan. • Ensure staff meet project timelines (site start-up, enrollment targets, database lock, close-out) and partner with leadership to mitigate issues.

🎯 Requirements

• You must be open to a dynamic work environment which includes regular interaction with several different physicians and site staff across a variety of locations. • You have extensive prior experience in a similar role with a proven track record of successful clinical study completion with adherence to timelines and milestones. • You bring knowledge and experience with GCP and global medical device regulations and have experience leading complex medical device studies. • You have strong experience of managing individuals. • You are proficient at utilizing clinical management systems and electronic data capture systems. • You have experience in global Contract Research Organization (CRO)/vendor management. • You bring an operational-excellence mindset, critical thinking, and make data-driven decisions. • You are a detail-oriented, critical thinking, independent problem-solver. • You are proficient at working in an extremely fast-paced environment while maintaining high attention to detail, quality, and accuracy. • You have excellent communication (written and verbal) and proven ability to influence outcomes. • Travel Required: 5-15%

🏖️ Benefits

• A front row seat to life changing CGM technology. • Learn about our brave #dexcomwarriors community . • A full and comprehensive benefits program. • Growth opportunities on a global scale. • Access to career development through in-house learning programs and/or qualified tuition reimbursement. • An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.