Senior Clinical Research Associate

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.

We invite you to become a part of a fast growing, purpose driven team in our newly established business centre in Vilnius! 

Summary:

As a Senior Clinical Research Analyst, you will support the execution and oversight of Dexcom Clinical Trials conducted globally (predominantly Trials based in the United States and Europe).  Be part of multi-national project teams and focus on delivering exemplary levels of customer service on multiple, challenging studies.

 
About the Role:

• Perform on-site or remote Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site are adequate for the conduct of the study. 
• Ensure compliance with pertinent regulations and accuracy of trial data
• Prepare monitoring visit reports to document all discussions, measures and actions made during a monitoring visit and/or remote monitoring.
• Conduct regular Trial Master File (TMF) site audits to ensure inspection readiness and support audit activities.
• Maintain regular communication with Clinical Trial Lead and Site Management personnel (based globally). 
• 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 as applicable.
• Collaborate effectively with peers and leadership across departments and professionally interact/build relationships with Investigators, IRBs, and key opinion leaders. 
• Develop study documentation, perform site selection/qualification, monitor study data and compliance, and other activities related to study operations.
• Contribute to process improvements across all aspects of clinical study operations.

About You:

• Ability and judgement to work under minimal supervision to plan and execute study operations, including on-site and remote monitoring, documentation, and generating progress reports.
• Strong GCP and clinical study background, including experience as a CRA; experience in the medical device industry and/or with diabetes is a plus.
• Skill and experience at working cross-functionally and globally to achieve goals.
• Ability to work on multiple studies concurrently and to work with co-monitors successfully to reduce overall time from last patient off study to database lock while improving site compliance.
• Experience with using electronic data capture systems (EDC), electronic source systems, Clinical Trial Management Systems (CTMS), and electronic trial master files (eTMF).
• Preference for multi-lingual candidates.

Travel:

15-30%

We Offer:

• Opportunity to work in global, innovative, fast-growing company.
• Flexible work.
• 5 additional vacation days.
• Health, Life and Accident insurance.
• Health and Wellness programs.
• Private Pension plan.
• Access to the best-in-class training and development programmes.
• Team buildings and events.
• Competitive salary and additional bonuses.

Sounds like you? Apply!

Monthly base salary for this position is from € 4025,00 gross. Final offer will depend on your qualifications, competencies, and professional experience.

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.