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About the Role
As a Sr. Staff Technical Program Manager, you will lead the planning and execution of complex clinical programs across the Asia Pacific region, helping shape clinical strategies that support product development, regulatory submissions, and business objectives. This is an exciting opportunity to drive impactful, multi-country studies while collaborating with diverse global stakeholders in a fast-paced and highly innovative environment.
Responsibilities
- 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.
- 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.
- Collaborate with functional leaders to develop and implement clinical study strategies, ensuring alignment with business objectives and regulatory requirements.
- Lead the full lifecycle of clinical studies, from protocol design and study startup through execution, closeout, and reporting.
- Manage study operations, including timelines, milestones, budgets, financial tracking, performance metrics, and key performance indicators (KPIs).
- Coordinate and prioritize activities across multiple studies to ensure project deliverables and timelines are achieved.
- Identify, assess, and mitigate risks related to study implementation, enrollment, compliance, data quality, and overall study success.
- Drive the selection, onboarding, and management of CROs and external vendors through competitive bid processes and ongoing performance oversight.
- Oversee CRO deliverables and study execution to ensure quality, compliance, and achievement of study objectives.
- 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.
- Oversee study startup activities, including contracts, Ethics Committee submissions, site initiation visits, site training, monitoring activities, and data integrity reviews.
- Develop and maintain dashboards, executive reports, and portfolio updates that communicate study progress, milestones, risks, and outcomes to leadership and stakeholders.
- Champion process improvements and innovative approaches that enhance study efficiency, quality, and operational excellence.
- Support clinical studies conducted across Asia Pacific markets, including Australia, New Zealand, Japan, Korea, Singapore, and other regional locations as needed.
Requirements
- Strong knowledge of clinical research regulations and Good Clinical Practice (GCP) requirements.
- Experience planning, managing, and executing clinical studies within the medical device industry.
- Demonstrated success leading complex, multi-country clinical programs and collaborating with global stakeholders.
- Experience developing clinical protocols, Informed Consent Forms (ICFs), and other essential clinical study documentation.
- Exceptional project management skills, including the ability to manage multiple priorities, budgets, timelines, and risks simultaneously.
- Strong analytical, problem-solving, and decision-making capabilities in complex and rapidly changing environments.
- Outstanding written, verbal, and presentation communication skills.
- Proven leadership and stakeholder management skills, with the ability to influence and drive alignment across cross-functional teams.
- Strong interpersonal skills and thrive in collaborative, global team environments.
- Comfortable working across APAC and U.S. time zones.
- Experience working in regulated environments such as medical devices, biotechnology, pharmaceuticals, or healthcare technologies.
- Experience managing external CROs supporting Class II and Class III medical device clinical studies.
- Experience supporting diabetes, digital health, or glucose monitoring device studies.
- Working knowledge of clinical research regulations and operational practices within Asia Pacific markets, including Australia, New Zealand, Japan, Korea, and Singapore.
- Proficiency in Microsoft Excel, Word, PowerPoint, Microsoft Project, and Smartsheet.
- Experience implementing process improvement initiatives that enhance clinical study efficiency, quality, and scalability.
Skills
- Clinical research regulations
- Good Clinical Practice (GCP)
- Clinical study planning
- Clinical study management
- Clinical study execution
- Medical device industry
- Multi-country clinical programs
- Global stakeholder collaboration
- Protocol development
- Informed Consent Forms (ICFs)
- Project management
- Budget management
- Timeline management
- Risk management
- Analytical skills
- Problem-solving
- Decision-making
- Communication skills
- Leadership skills
- Stakeholder management
- Interpersonal skills
- Team collaboration
- CRO management
- Process improvement
- Microsoft Excel
- Microsoft Word
- Microsoft PowerPoint
- Microsoft Project
- Smartsheet
Location
- Asia Pacific
Work Type
- Hybrid
Experience Level
- Senior Staff
Education Level
- Bachelor's degree in a technical discipline
- Master's degree
- PhD
Benefits
- 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
About the Company
- Australasian Medical and Scientific Limited (AMSL) and New Zealand Medical & Scientific (NZMS) are subsidiaries of Dexcom, a worldwide leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes.
- We form partnerships with world leading medical device, pharmaceutical and scientific innovators and are passionate about introducing and establishing advances in healthcare and science for the benefit of patients and healthcare providers.
- Working in the Medical Devices Industry, you will be exposed to a broad range of products that have life changing effects on a patient's quality of life.
- At Dexcom, Clinical Affairs plays a critical role in advancing innovative diabetes technology through high-quality clinical evidence and strategic study execution.
- As part of a global, cross-functional organization, our team partners closely with Product Development, Regulatory Affairs, Quality, and Operations to bring life-changing medical devices to market.
- An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Equal Opportunity
- At Dexcom, we are committed to providing a fair and inclusive recruitment process, and welcome candidates of all genders and gender identities to apply.
- If any wording in this description appears unintentionally gendered or exclusionary, please be assured this is not intentional.
- Should a reasonable accommodation be necessary to aid a disability, requests should be sent to Dexcom Talent Acquisition at talentacquisition@dexcom.com.