- Location
- Penang,MY, MY
- Type
- Full-time
- Department
- Healthcare
- Education
- Master
- Source
- Eightfold
Description
Meet the Team
At Dexcom, our mission is to empower people to take control of their health through innovative continuous glucose monitoring technology. The Clinical Affairs team plays a critical role in advancing this mission by generating high-quality clinical evidence that supports product innovation, regulatory compliance, and patient outcomes.
As a Clinical Affairs Supervisor, you will lead a team responsible for executing sponsor-investigator clinical studies. You'll have the opportunity to collaborate with cross-functional teams, clinical experts, and key stakeholders while driving operational excellence and continuous improvement within clinical research activities.
Where You Come In
- You will lead and oversee sponsor-investigator clinical studies from study start-up through study close-out.
- You will supervise and develop a team of Clinical Research professionals responsible for study execution and trial management.
- You will create and maintain study-related documentation, including source documents, case report forms (CRFs), IRB submissions, clinical training materials, and study tools.
- You will partner with Clinical Affairs leadership and cross-functional stakeholders to plan, execute, and monitor clinical studies.
- You will establish and track study timelines, deliverables, and operational milestones to ensure successful trial execution.
- You will oversee subject recruitment, study visits, regulatory documentation, data collection activities, and study close-out processes.
- You will ensure studies are conducted in accordance with study protocols, Good Clinical Practice (GCP), ICH Guidelines, applicable regulations, and Dexcom SOPs.
- You will identify, document, and escalate adverse events, serious adverse events, protocol deviations, and other study risks as required.
- You will establish performance metrics and quality benchmarks while driving continuous improvement initiatives across clinical operations.
- You will build and maintain strong working relationships with internal stakeholders, Institutional Review Boards (IRBs), healthcare professionals, regulatory agencies, and key opinion leaders.
What Makes You Successful
- You have a Bachelor's degree in Life Sciences, Nursing, Pharmacy, Healthcare, or a related discipline.
- You have 10+ years of Clinical Affairs and Clinical Operations experience within the medical device, pharmaceutical, or Clinical Research Organization (CRO) industry.
- You possess comprehensive knowledge of clinical trial design, Good Clinical Practice (GCP), ICH guidelines, regulatory requirements, quality systems, and risk management practices.
- You hold an active healthcare practitioner license and are eligible to serve as a Principal Investigator (RN, MD, PharmD, or equivalent).
- You have demonstrated success leading and developing clinical research teams in a global environment.
- You have strong project management skills with the ability to manage multiple priorities in a fast-paced environment.
- You have exceptional written and verbal communication skills and can effectively engage with stakeholders across diverse cultures and functions.
- You are proficient in clinical trial systems, clinical databases, and study management tools.
- You are fluent in English; additional Asian language proficiency is considered an advantage.
- You are highly organized, detail-oriented, and capable of driving operational excellence through continuous improvement.
- You demonstrate strong leadership, professional integrity, sound judgment, and the ability to build collaborative relationships.
- Experience with continuous glucose monitoring (CGM) technologies and diabetes management is preferred.
What You'll Get
- A front-row opportunity to contribute to innovative clinical research that improves the lives of people living with diabetes.
- The chance to lead and develop a high-performing clinical operations team within a growing global organization.
- Opportunities to collaborate with global cross-functional partners, healthcare professionals, and industry experts.
- A culture that values innovation, continuous learning, collaboration, and operational excellence.
- Meaningful work supporting groundbreaking technology that positively impacts patients worldwide.
Travel Required
- 15-25%
Experience and Education Requirements
- Typically requires a Bachelor’s degree with 5-8 years of industry experience
- Informal management/ team lead experience
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