Dexcom · 5 months ago
Manager Clinical Affairs
United States
Full-time
Remote
Mid, Senior Level
$117K/yr - $194K/yr
8+ years expDexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM), dedicated to improving human health. As a Manager in Clinical Affairs, you will lead a team responsible for site management activities for clinical studies, ensuring high-quality regulatory compliance and timely delivery of milestones while driving the development of clinical procedures and processes.
DiabetesHealth DiagnosticsMedical DeviceSensor
Responsibilities
Perform line management for a team, including hiring, training/mentoring, resource allocation/assignments, performance and compliance assessments/reviews, recommending salaries and promotions, and implementing performance improvement plans and remedial actions as needed
Lead the team to ensure high-quality site management, regulatory compliance, and timely delivery of study site milestones, including, but not limited to:
Accountable for global or regional operational leadership on one or more clinical trials, depending on program’s priority and breadth
Oversee site identification, qualification, and selection processes
Ensure timely completion of Site Qualification Visits (SQVs) and approvals
Confirm site activation readiness, including supply and equipment receipt
Supervise Site Initiation Visits (SIVs) and Close-Out Visits (COVs)
Ensure ongoing site support and clear communication
Provide support and allocate resources for internal or external audits/inspections and ensure resolution of audit/inspection findings
Ensure maintenance of site-level Trial Master File (TMF) and sponsor TMF for archiving
Oversee development and distribution of Investigator Site Files and study manuals
Facilitate IRB/EC submissions and end-of-study notifications
Lead the development and implementation of improved systems, frameworks, policies, and tools to support a culture of data use for decision-making across programs
Provide strategic direction as a subject matter expert in site management
Develop and oversee key performance metrics for the team and provide regular and ad hoc reporting of metrics to Clinical Affairs leadership
Lead a team of Site Managers who will facilitate training on the use of study-specific equipment during the conduct of clinical study visits to ensure proper use of the equipment and adherence to the Clinical Investigation Plan
Educating site staff on use of the study-specific equipment, including calibration, use, and troubleshooting
Communicating technical information clearly and effectively
Developing effective working relationships with site staff, with whom you will interact on a regular basis
Ensure that staff meet or exceed project and functional timelines and deliverables (e.g., site start-up, enrollment targets, database lock, close-out, etc.). Partner with leadership to ensure shared study timelines are met or exceeded
Proactively identify issues and create mitigation strategies in collaboration with leadership
Qualification
Required
Typically requires a Bachelor's degree with 8 – 12 years of industry experience
Requires a degree in technical discipline
2 -5 years of previous management of lead experience
Extensive prior experience in a similar role with a proven track record of successful clinical study completion with adherence to timelines and milestones
Knowledge and experience with GCP and global medical device regulations and have experience leading complex medical device studies
Strong experience of managing individuals
Proficient at utilizing clinical management systems and electronic data capture systems
Experience in global Contract Research Organization (CRO)/vendor management
Operational-excellence mindset, critical thinking, and make data-driven decisions
Detail-oriented, critical thinking, independent problem-solver
Proficient at working in an extremely fast-paced environment while maintaining high attention to detail, quality, and accuracy
Excellent communication (written and verbal) and proven ability to influence outcomes
Benefits
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.
Company
Dexcom
Dexcom develops, manufactures, and distributes continuous glucose monitoring systems for diabetes management.
10001+ employees
H1B Sponsorship
Dexcom has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (54)
2024 (41)
2023 (67)
2022 (75)
2021 (49)
2020 (36)
Funding
Current Stage
Public CompanyTotal Funding
$2.16BKey Investors
RWI Group
2023-05-02Post Ipo Debt· $1B
2020-05-12Post Ipo Debt
2018-11-01Post Ipo Equity· $750M
Leadership Team
Jacob Leach
Chief Operating Officer
Matt Dolan
Executive Vice President, Strategy, Corporate Development & Dexcom Labs
Recent News
2026-01-16
Medical Device Network
2026-01-15
Company data provided by crunchbase