Sr Staff Clinical Technical Program Manager, APAC

22 Australasian Medical & Scientific Limited; Sydney; On-site; AUD 180,000 - 240,000; Full time

Benefits offered by this job

CGM technology exposure

Global growth opportunities

Comprehensive benefits program

Tuition reimbursement

Career development

Job summary

Australasian Medical and Scientific Limited (AMSL) is seeking an Sr. Staff Technical Program Manager to lead complex APAC clinical programs.

You will guide study design, regulatory submissions, and partner with global teams to enable successful product development in a fast-paced environment. Role demands extensive clinical research experience in medical devices, strong leadership, robust project management, and willingness to travel regionally.

Qualifications

• Knowledge of clinical research regulations and GCP requirements.
• Experience planning, managing, and executing clinical studies in the medical device space.
• Proven success leading complex, multi-country programs with global stakeholders.
• Experience developing protocols, ICFs, and essential study docs.
• Strong project management: budgets, timelines, risks, priorities.
• Excellent analytical, problem-solving, and decision-making abilities.
• Outstanding written, verbal, and presentation skills.
• Proven leadership and stakeholder management across cross-functional teams.

Responsibilities

• Lead cross-functional clinical study teams to meet goals and timelines.
• Partner with executives, Product Development, Regulatory, QA, Operations and CROs to set study plans.
• Develop and implement study strategies aligned with regulatory and business needs.
• Oversee full lifecycle of clinical studies from protocol design to reporting.
• Manage study operations: timelines, milestones, budgets, KPIs.
• Coordinate multiple studies and prioritize deliverables and timelines.
• Identify and mitigate risks related to enrollment, data quality and compliance.
• Oversee CROs and vendors with bids and performance oversight.
• Maintain essential study documents (CIPs, ICFs, CRFs) respecting regulations.

Skills

GCP knowledge

Clinical study planning

Multi-country programs

Documentation development

Project management

Analytical thinking

Verbal and written communication

Leadership

Stakeholder management

Cross-functional collaboration

Travel willingness

Education

Bachelor’s degree in a technical discipline

Master’s degree or PhD in related field

Tools

Microsoft Excel

Microsoft Project

Smartsheet

Word

PowerPoint

Job description

About Australasian Medical and Scientific Limited (AMSL) and New Zealand Medical & Scientific (NZMS)

AMSL and 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.

Meet the Team

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.

Role Overview

As an 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.

Key Responsibilities

• 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. #LIHybrid

Since 1999, Dexcom has simplified and revolutionized diabetes management, positively impacting millions worldwide. At Dexcom, we're more than just a medical device company; we're a collective of visionary thinkers, trailblazers, and problem solvers. Our mission transcends the ordinary. We aim to revolutionize healthcare, one groundbreaking technology at a time.