Manager Clinical Affairs

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.

We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

Meet the team:

As a Manager in Clinical Affairs at Dexcom, you’ll be an integral part of our mission to empower people to take control of their health. In this position, you’ll lead a team of global direct reports responsible for comprehensive site management activities. This includes site selection, qualifications, activation, training, proctoring, communications, and closeout for all clinical studies sponsored by Dexcom. You will be responsible for the direct management and development of personnel. Additionally, you will drive the development and improvement of clinical procedures, processes, and templates in support of Dexcom’s continuous quality improvement efforts. If you thrive in a fast-paced, evolving environment and are committed to building a world-class Clinical Affairs organization, we’d love to have you on our team.

Where you come in:

• 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. In support of this, the team will be responsible for:
  • 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 a