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 outcomes.

What you’ll get:

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.

• A full and comprehensive benefits program.

• Growth opportunities on a global scale.

• Access to career development through in-house learning programs and/or qualified tuition reimbursement.

• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

Travel Required:

• 5-15%

Experience and Education Requirements:

• Typically requires a Bachelors degree with 13+ years of industry experience.

• 5-8 years of previous people management experience.

Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.

Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com. 

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at talentacquisition@dexcom.com. 

View the OFCCP's Pay Transparency Non Discrimination Provision at this link. 

Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided:  https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
 

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