This job was posted by https://www.azjobconnection.gov : For more information, please see: https://www.azjobconnection.gov/jobs/6796346 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:

The Clinical Operations Supervisor will provide day-to-day direction, leadership, and execution of conducting sponsor-investigator studies. A successful leader in this role will be knowledgeable in each of the provided areas but also demonstrate a flexible and enthusiastic attitude in establishing new and creative approaches to drive the team forward. This role is fundamental in establishing and conducting a specific team, passionate about execution of feasibility clinical studies and will require creative and critical thinking, attention to detail, and a strong ability to prioritize efforts with maximum value add and drive the team toward those.

Where you come in:

• You will lead, assist and conduct clinical studies from start up to closure.
• You will assist with developing clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc) under little to no supervision.
• You will assist management with departmental audits of clinical studies and procedures.
• You will collaborate with project management, individual contributors and direct manager to establish and maintain study timelines.
• You will clearly demonstrate understanding of clinical study management/prioritization.
• You will manage all clinical tasks and deliverables to met clinical timelines.
• You will supervise a team of Clinical Research staff who will implement clinical studies. This includes mentor and training staff in the conduct of clinical trials, protocol requirements, communication, and Dexcom policies and procedures, build training strategies, ensure staff are delegated and trained appropriately and detailed.
• You will assist with the management of studies by coordinating daily operations including methods, workflow and implementation of procedures, establish KPI and benchmark metrics to measure responsible tasks, improve quality in the conduct of the studies, and lead continuous improvement initiatives.
• You will partner with Clinical Affairs management and direct reports to develop and execute clinical studies. This will include writing and/or reviewing assigned protocols in consultation with Clinical Affairs management and cross-functional partners.
• You will incorporate understanding of study objectives and key data points when planning for each assigned protocol
• Yo will execute and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Dexcom\'s SOPs
• You will work with direct reports to execute assigned clinical trials including start up, subject recruitment & scheduling, collection of regulatory documents, conducting study visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, and providing IRB close-out reports.
• You will be responsible for identifying and escalating safety events as well as identifying and escalating protocol deviations.
• You may assist with assessing trends for safety and protocol deviations and presenting this to study team and study manager. Maintain organization, preparation, ordering, and set-up of supplies and equipment for the Mesa site.
• You will be the quality control SME for study-related documents and be accountable for their correct distribution.
• You will provide training to study staff and subjects.
• You will communicate effectively and professionally with coworkers, leadership, and study subjects.
• You will collaborate effectively with peers and leadership across departments and can professionally interact/establish relationships with FDA, IRB, and key opinion leaders.
• This position assumes and performs other duties as assigned.