Sr. Manager, Clinical Affairs

The Company

Dexcom Corporation (NASDAQ DXCM; Market Cap $44.3B) 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 nearly 10,000 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 remote position, you’ll lead a team of direct reports, including leaders, ensuring the timely, effective, and high-quality completion of Dexcom’s global clinical studies. Your responsibilities will extend beyond study management – you’ll also drive organizational evolution by prioritizing needs, managing metrics/KPIs, and business project improvements. 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:

• You will lead a global team of Clinical Staff, possibly including people leaders (e.g., Supervisors and Managers), which involves:

  • Active mentoring, regular coaching, and developing people to build skills and elevate capabilities;

  • Accountability to ensure the team is trained and follows the currently approved protocol/amendment(s), SOPs, GCP, PHI, and applicable regulatory requirements;

  • Forecasting staffing demand, communication of needs, and assigning staff to studies; and

  • Establishing and driving organized reviews of metrics and KPIs to track progress and assign clear actions (e.g., cycle times, query age, SDV rate, partner ratings, system issue tracking, etc.). 

• You will lead the Clinical Operations team to drive deliverables to meet the overall project timelines, influencing internal and external partners to support on-time-delivery through relationship management skills as well as execute a well-controlled operation.

• You will be responsible for comprehensive operational and relationship management of clinical trial activities associated with our clinical research sites. 

• You will be responsible for successful research equipment proctoring, including set-up and training for specialized research equipment at our clinical research sites; ensuring operational success via in person oversight during procedures; remote review of equipment utilization/performance; and continuous training/education for site research staff.  Your team will also be responsible for guiding improvements from insights gained through hands on work with the research staff operating the equipment.

• You will provide team and project updates and reports.

• This position assumes and performs other duties as assigned.   

What makes you successful:

• You have strong experience managing individuals, with preference for individuals who have managed people leaders and global resources.

• You bring knowledge and experience with GCP and global medical device regulations and have experience leading complex medical device studies with FDA submission

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

• You have experience utilizing and training on technical equipment in a clinical research setting (e.g., new or technically challenging hardware and software)

• You have experience in global CRO/vendor management

• You bring an operational-excellence mindset make data-driven decisions.

• You are a detailed-oriented, critical thinking, independent problem-solver

• You are proficient at wor