Staff Clinical Program Manager

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:

• The Clinical Program Manager provides leadership and direction to Clinical Affairs in planning and execution of clinical strategies in a key business area. A successful leader in this role will understand and translate business strategy into planning an execution of clinical studies to support broader objectives.

• Excellent communication skills are required to manage and facilitate collaborations within the Clinical Affairs team, with all internal core team functional groups, and with external partner stakeholders. This role requires a strong technical background and experience in both product development and clinical study planning and execution, ideally in a regulated environment such as medical device development.

Where you come in:

• You will serve as a member of core team(s), providing strategic direction to study teams to meet goals and timelines
• You will interface with representatives from key functional groups including Executive Management, Product Development/R&D, Regulatory Affairs, Quality Assurance, and Operations as well as Clinical Research Organizations (CROs) to set operational direction and strategy for clinical study activities.
• You will work in collaboration with functional leaders to design/implement strategies and track project plans related to study design
• You will drive the full spectrum of the clinical execution from the design phase to close-out in collaborating closely with the study team. 
• You will track and manage strategic study operations including KPIs, study timelines, all budgetary and financial information, etc.
• You will coordinate and prioritize activities amongst trials/establish study milestones to ensure timelines are met
• You will recommend and implement innovative ideas to increase efficiency and quality of study management activities
• You will identify and mitigate risks to study implementation, enrollment, conduct, compliance, and completion
• You will drive selection of Contract Research Organizations (CROs) through competitive bid process and other necessary vendors to support study requirements
• You will provide oversight and execution of CRO study deliverables to ensure that objectives are met

What makes you successful:

• You have a strong regulatory knowledge, including Good Clinical Practices (GCPs).
• You have experience with protocol and ICF development.
• You have experience with clinical study planning and execution in the medical device industry.
• You have exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.
• You have excellent communication (written and verbal) and presentation skills along with leadership qualities.
• You have strong interpersonal skills and ability to work effectively on cross-functional & global teams.
• You thrive in an extremely fast-paced environment.

Optional/nice to have:

• Successful experience managing outside CRO groups in Class II/III, preferably diabetes, device studies
• Proficient with MS Office Suite (Excel, Word and PowerPoint), MS Project, and Smartsheet

What you’ll get: (this section should not be modified)

• A front row seat to life changing CGM technology. Learn about our br