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 Clinical Site Manager/Clinical Research Associate (CRA) 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 support execution of clinical studies while building strong relationships with clinical trial sites. 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:
You will support execution of clinical studies while building strong relationships with clinical trial sites, including, but not limited to:
Set-up and training remotely and/or on-site as needed.
Hosting regular meetings/communications with active sites.
Tracking & delivering milestones and enrollment targets; partnering to implement contingency/risk mitigation plans when needed. Providing regular, formal updates to Clinical Trial Lead, Clinical Program Manager, and to line manager.
Ensure site devices and supplies remain adequate for study.
On-site proctoring of visits as needed.
You will collaborate cross-functionally to ensure robust study processes, on-time monitoring, audit-readiness both at sponsor and sites, and will contribute to study reports and regulatory submission deliverables.
Ensure site provides accurate, complete, timely data.
Confirm correct data file naming for download files from study instrumentation.
Submitting monitoring visit reports in a timely fashion.
Data cleaning, DB lock, and COV support.
You will collaborate effectively with peers and leadership across departments and professionally interact/build relationships with Investigators, IRBs, and key opinion leaders.
You will support the development of study documentation, monitor study data and compliance, and other activities related to study operations.
You will contribute to process improvements across all aspects of clinical study operations.
Support the identification and qualification of new clinical research sites.
What makes you successful:
You have the ability and judgement to work under supervision to plan and execute study operations, including on-site and remote monitoring, requesting, and tracking supplies.
You have skill and experience at working cross-functionally to achieve goals.
You have strong GCP and clinical study background, including experience as a CRA; experience in the medical device industry and/or with diabetes is a plus.
You have the ability to work on multiple studies concurrently and to work with co-monitors successfully to reduce overall time from LPOS to database lock while improving site compliance.
You have experience with using electronic data capture systems (EDC), Clinical Trial Management Systems (CTMS), and electronic trial master files (eTMF).
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:
15 - 25% (may include some international travel)
Experience and Education Requirements:
Typically requires a Bachelor's degree in a technical discipline, and a minimum of 2-5 years related experience or Master's degree and 0-2 years equivalent experience.
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.
