Supervisor Clinical Affairs
Dexcom, Inc

Job Info

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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:

The Clinical Operations Supervisor will provide day-to-day direction, leadership, and execution of conducting sponsor-investigator studies. A successful leader in this role will be knowledgeable in each of the provided areas but also demonstrate a flexible and enthusiastic attitude in establishing new and creative approaches to drive the team forward. This role is fundamental in establishing and conducting a specific team, passionate about execution of feasibility clinical studies and will require creative and critical thinking, attention to detail, and a strong ability to prioritize efforts with maximum value add and drive the team toward those.

Where you come in:

• You will lead, assist and conduct clinical studies from start up to closure.
• You will assist with developing clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc) under little to no supervision.
• You will assist management with departmental audits of clinical studies and procedures.
• You will collaborate with project management, individual contributors and direct manager to establish and maintain study timelines.
• You will clearly demonstrate understanding of clinical study management/prioritization.
• You will manage all clinical tasks and deliverables to met clinical timelines.
• You will supervise a team of Clinical Research staff who will implement clinical studies. This includes mentor and training staff in the conduct of clinical trials, protocol requirements, communication, and Dexcom policies and procedures, build training strategies, ensure staff are delegated and trained appropriately and detailed.
• You will assist with the management of studies by coordinating daily operations including methods, workflow and implementation of procedures, establish KPI and benchmark metrics to measure responsible tasks, improve quality in the conduct of the studies, and lead continuous improvement initiatives.
• You will partner with Clinical Affairs management and direct reports to develop and execute clinical studies. This will include writing and/or reviewing assigned protocols in consultation with Clinical Affairs management and cross-functional partners.
• You will incorporate understanding of study objectives and key data points when planning for each assigned protocol
• You will execute and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Dexcom's SOPs
• You will work with direct reports to execute assigned clinical trials including start up, subject recruitment & scheduling, collection of regulatory documents, conducting study visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, and providing IRB close-out reports.
• You will be responsible for identifying and escalating safety events as well as identifying and escalating protocol deviations.
• You may assist with assessing trends for safety and protocol deviations and presenting this to study team and study manager. Maintain organization, preparation, ordering, and set-up of supplies and equipment for the Mesa site.
• You will be the quality control SME for study-related documents and be accountable for their correct distribution.
• You will provide training to study staff and subjects.
• You will communicate effectively and professionally with coworkers, leadership, and study subjects.
• You will collaborate effectively with peers and leadership across departments and can professionally interact/establish relationships with FDA, IRB, and key opinion leaders.
• This position assumes and performs other duties as assigned.

What makes you successful:

• You have prior experience as a study coordinator and/or Clinical Research Associate or CTL.
• You have experience in exercising good judgment in measuring risk vs business needs.
• You have excellent communication (written and verbal) and presentation skills along with leadership qualities.
• You have strong organizational skills and ability to take care of challenging priorities.
• You are proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.
• You have the ability to be independent, multitask and results-oriented with a hands-on attitude in a fast-paced and energetic environment with experience in assembling a plan and executing on the details.
• You are willing to work in a very fast-paced environment with high attention to detail and accuracy.
• You have a data-driven decision-making approach.
• You have strong interpersonal communication skills and ability to work optimally on cross-functional & global teams.
• You are a pro-active, energetic, self-assured professional with high personal integrity and the ability to develop and maintain good interpersonal relationships.
• You are an analytical, strategic thinker with leadership ability and style that demonstrates professionalism and establishes respect.
• You have excellent organizational skills and attention to detail.
• Having experience in continuous glucose monitoring (CGM) is a plus.

Experience and Education Requirements:

• Typically requires a Bachelor's degree in a technical discipline with 5-8 years of industry experience.
• Informal management/team lead experience.
• Active RN, BSN or LVN license in Arizona.
• Professional certification (CCRA (ACRP), CCRP (SoCRA), PMP, ACRP, RAPS).
• Current GCP (Good Clinical Practice) Training.

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%
• Local to Mesa, Arizona and willing to travel to San Diego, California.

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

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