Senior Clinical Trial Lead
Dexcom, Inc

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 Clinical Trial Lead 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 will lead a team of your clinical operations peers to ensure the timely, effective, and high-quality completion of Dexcom's clinical studies. If you thrive in a fast-paced, evolving environment, and are committed to delivering on world-class Clinical Research, we'd love to have you on our team.

Where you come in:

For each clinical study assigned, you will be the single point of accountability for all clinical operations activities (activities span early study design and start-up through active study and close-out) with support from management and functional experts:

• You will provide direction and leadership to the clinical operations study team and manage the team's day-to-day study work.
  
• You will establish, track, and deliver on clinical operations milestones to meet program deliverables.
  
• You will 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 leading study team meetings, sending agendas & minutes.
  
• You will identify risks that may impact the overall project plan and propose contingency plans.
  
• You will lead study meetings and alignment meetings, as needed.
  
• You will be responsible for communication & escalation.
  
• You will develop and/or provide input in the development of clinical trial related documents, including but not limited to:
  
• Study protocols, training materials, case report forms, informed consents, IRB submissions, source documents, timelines, clinical monitoring plans, reference manuals, supply listings, monitoring tools, presentations, meeting materials (agenda and minutes).
  
• You will collaborate with Clinical Affairs management, Clinical Program Management, Clinical Science, Clinical Supply/Logistics, Compliance, and the various functional groups (R&D, Biometrics, Medical Affairs) as well as external contacts (study investigators and research coordinators).
  
• You may provide CRO oversight and management, with support from clinical program management and leadership.
  
• You will assist management with departmental audits of clinical studies and procedures.
  

What makes you successful:

• You bring experience in similar role, with proven track records of successful clinical study completion, adhering to timelines, budget, and milestones.
  
• You possess an in-depth knowledge of applicable clinical research guidelines and regulations, as well as software, tools, and systems used in clinical conduct (e.g., CTMS, eCRF, TMF, etc.).
  
• You can work independently and act proactively to manage all clinical tasks and deliverables. When support is needed, you come prepared with ideas/suggestions.
  
• You bring a throrough understanding and technical expertise in the processes associated with study preparation, study management, knowledge of Good Clinical Practices (GCPs), monitoring, clinical, and regulatory operations.
  
• You have good communication (written and verbal) and ability to lead a matrixed team.
  
• You think critically, you are organized, and have a strong attention to detail.
  
• You can manage multiple priorities well and quickly triage incoming work.
  
• You welcome feedback and approach your development with growth mindset.
  

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 opportunitites 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 communites we serve.
  

Travel Required:

• 15 - 25%
  

Experience and Education Requirements:

• Typically requires a Bachelor's degree in a technical discipline, and a minimum of 5-8 years of related experience or Master's degree and 2-5 years equivalent industry experience or a PhD and 0-2 years 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.

Salary:
$95,900.00 - $159,900.00

This job has expired.