Clinical Affairs Manager

Dexcom

full-time

Posted on: 8/23/2025

Origin: • 🇺🇸 United States • California

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💰 $116,600 - $194,400 per year

SeniorLead

Google Cloud Platform

About the role

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.

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%