Where You Come In
You serve as a key member of cross-functional core teams, providing strategic direction and leadership to clinical study teams to ensure successful execution against goals and timelines.
You partner with Executive Management, Product Development, Regulatory Affairs, Quality Assurance, Operations, and external Clinical Research Organizations (CROs) to establish operational strategies and clinical study plans.
You collaborate with functional leaders to develop and implement clinical study strategies, ensuring alignment with business objectives and regulatory requirements.
You lead the full lifecycle of clinical studies, from protocol design and study startup through execution, closeout, and reporting.
You manage study operations, including timelines, milestones, budgets, financial tracking, performance metrics, and key performance indicators (KPIs).
You coordinate and prioritize activities across multiple studies to ensure project deliverables and timelines are achieved.
You identify, assess, and mitigate risks related to study implementation, enrollment, compliance, data quality, and overall study success.
You drive the selection, onboarding, and management of CROs and external vendors through competitive bid processes and ongoing performance oversight.
You oversee CRO deliverables and study execution to ensure quality, compliance, and achievement of study objectives.
You develop, review, and maintain key study documentation, including Clinical Investigation Plans (CIPs), Informed Consent Forms (ICFs), and Case Report Forms (CRFs), in accordance with applicable regulations.
You oversee study startup activities, including contracts, Ethics Committee submissions, site initiation visits, site training, monitoring activities, and data integrity reviews.
You develop and maintain dashboards, executive reports, and portfolio updates that communicate study progress, milestones, risks, and outcomes to leadership and stakeholders.
You champion process improvements and innovative approaches that enhance study efficiency, quality, and operational excellence.
You support clinical studies conducted across Asia Pacific markets, including Australia, New Zealand, Japan, Korea, Singapore, and other regional locations as needed.
What Makes You Successful
Must-Have Qualifications
You have strong knowledge of clinical research regulations and Good Clinical Practice (GCP) requirements.
You have experience planning, managing, and executing clinical studies within the medical device industry.
You have demonstrated success leading complex, multi-country clinical programs and collaborating with global stakeholders.
You have experience developing clinical protocols, Informed Consent Forms (ICFs), and other essential clinical study documentation.
You have exceptional project management skills, including the ability to manage multiple priorities, budgets, timelines, and risks simultaneously.
You have strong analytical, problem-solving, and decision-making capabilities in complex and rapidly changing environments.
You have outstanding written, verbal, and presentation communication skills.
You have proven leadership and stakeholder management skills, with the ability to influence and drive alignment across cross-functional teams.
You have strong interpersonal skills and thrive in collaborative, global team environments.
You are comfortable working across APAC and U.S. time zones and are willing to travel regionally as needed.
Your experience includes working in regulated environments such as medical devices, biotechnology, pharmaceuticals, or healthcare technologies.
Nice-to-Have Qualifications
You have experience managing external CROs supporting Class II and Class III medical device clinical studies.
You have experience supporting diabetes, digital health, or glucose monitoring device studies.
You bring working knowledge of clinical research regulations and operational practices within Asia Pacific markets, including Australia, New Zealand, Japan, Korea, and Singapore.
Your proficiency includes Microsoft Excel, Word, PowerPoint, Microsoft Project, and Smartsheet.
You have experience implementing process improvement initiatives that enhance clinical study efficiency, quality, and scalability.
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
25-50%
Experience and Education Requirements
Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 13+ years related experience or a Master’s degree and 8+ years equivalent industry experience of a PhD and 5+ years of experience.
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