Manager Clinical Affairs

Dexcom; United States; Remote; USD 116,000 - 195,000; Full time

Job summary

A leading health technology firm seeks a Manager in Clinical Affairs to lead site management activities and ensure timely delivery of clinical studies. The ideal candidate has extensive experience in clinical study completion and team leadership. This role provides a unique opportunity to make a significant impact on health outcomes globally while working in a dynamic environment.

Benefits

Comprehensive benefits program

Growth opportunities

Access to career development programs

Qualifications

• 8-12 years of industry experience required.
• 2-5 years of previous management experience preferred.
• Proficiency in managing clinical studies.

Responsibilities

• Lead a team responsible for site management activities.
• Oversee site identification, qualification, and selection.
• Ensure timely delivery of study site milestones.

Skills

Line management

Team leadership

GCP knowledge

Clinical study completion

Data-driven decision-making

Education

Bachelor’s degree in technical discipline

Tools

Clinical management systems

Electronic data capture systems

Job description

Overview

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. 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 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 global direct reports responsible for comprehensive site management activities. This includes site selection, qualifications, activation, training, proctoring, communications, and closeout for all clinical studies sponsored by Dexcom. You will be responsible for the direct management and development of 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.
• Lead the team to ensure high-quality site management, regulatory compliance, and timely delivery of study site milestones, including, but not limited to:
  • Accountable for global or regional operational leadership on one or more clinical trials, depending on program\'s priority and breadth.
  • Oversee site identification, qualification, and selection processes.
  • Ensure timely completion of Site Qualification Visits (SQVs) and approvals.
  • Confirm site activation readiness, including supply and equipment receipt.
  • Supervise Site Initiation Visits (SIVs) and Close-Out Visits (COVs).
  • Ensure ongoing site support and clear communication.
  • Provide support and allocate resources for internal or external audits/inspections and ensure resolution of audit/inspection findings.
  • Ensure maintenance of site-level Trial Master File (TMF) and sponsor TMF for archiving.
  • Oversee development and distribution of Investigator Site Files and study manuals.
  • Facilitate IRB/EC submissions and end-of-study notifications.

• Lead the development and implementation of improved 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 site management.
  • Develop and oversee key performance metrics for the team and provide regular and ad hoc reporting of metrics to Clinical Affairs leadership.

• Lead a team of Site Managers who will facilitate training on the use of study-specific equipment during the conduct of clinical study visits to ensure proper use of the equipment and adherence to the Clinical Investigation Plan. In support of this, the team will be responsible for:
  • Educating site staff on use of the study-specific equipment, including calibration, use, and troubleshooting.
  • Communicating technical information clearly and effectively.
  • Developing effective working relationships with site staff, with whom you will interact on a regular basis.

• Ensure that staff meet or exceed project and functional timelines and deliverables (e.g., site start-up, enrollment targets, 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 must be open to a dynamic work environment which includes regular interaction with several different physicians and site staff across a variety of locations.
• 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 strong experience of managing individuals.
• You are proficient at utilizing clinical management systems and electronic data capture systems.
• You have experience in global Contract Research Organization (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.
• 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 Bachelor’s degree with 8 – 12 years of industry experience.
• Requires a degree in technical discipline.
• 2 -5 years of previous management of lead 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 [e-mail].

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 [e-mail].

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: $116,600.00 - $194,400.00