Senior APAC Clinical Program Lead – Medical Devices

22 Australasian Medical & Scientific Limited; Sydney; Sur place; AUD 180 000 - 240 000; Plein temps

Avantages offerts par ce poste

CGM technology exposure

Global growth opportunities

Comprehensive benefits program

Tuition reimbursement

Career development

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

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

Formation

Bachelor’s degree in a technical discipline

Master’s degree or PhD in related field

Outils

Microsoft Excel

Microsoft Project

Smartsheet

Word

PowerPoint

Description du poste

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.