Senior Manager, Monitoring, 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 Senior 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 direct reports and oversee the delivery of high-quality and compliant monitoring activities for all clinical studies sponsored by Dexcom. You will be responsible for the direct management and development of Monitoring 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.

• Manage the quality and compliance of monitoring activities across global studies, ensuring that the monitoring of clinical studies meets the highest standards for scientific quality, integrity, and ethics, and is conducted in accordance with Dexcom’s global clinical procedures, study protocols, GCP, and all applicable regulations.

  • Provide support and allocate resources for internal or external audits/inspections and ensure resolution of audit/inspection findings.

• Lead the development and implementation of improved monitoring 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 monitoring.

  • Develop and oversee key performance metrics for the team and provide regular and ad hoc reporting of metrics to Clinical Affairs Leadership.

• Ensure that staff meet or exceed project and functional timelines and deliverables (e.g., site start-up, 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.

What makes you successful:

• 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 experience developing and managing monitoring systems, frameworks, and tools.

• You have strong experience managing individuals.

• You are proficient at utilizing clinical management systems and electronic data capture systems.

• You have experience in global 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 ou