Manager, Clinical Research (Medical Devices)

Location: North Ryde, New South Wales, Australia; hybrid working arrangement. Up to 20% domestic and international travel may be required.

Company

Johnson & Johnson MedTech develops healthcare and orthopedic solutions, with DePuy Synthes focused on surgical and orthopedic products.

What you will do

• Lead end-to-end clinical study operations, including feasibility, vendor and CRO engagement, start-up, execution, and close-out.
• Assess and select clinical sites based on experience, enrollment potential, quality history, contracting, and start-up timelines.
• Develop study plans, enrollment projections, monitoring strategies, budgets, timelines, and escalation pathways.
• Coordinate cross-functional stakeholders across R&D, Medical Affairs, Regulatory, Quality, Biostatistics, and Data Management.
• Plan monitoring resources and coordinate CRA coverage, CRO capacity, and quality oversight.
• Support inspection readiness, audits, corrective and preventive actions, status reporting, and lessons learned.

Requirements

• Bachelor’s degree in Life Sciences, Health Sciences, Engineering, or a related discipline.
• 6–8 years of progressive experience in clinical research, clinical operations, medical device research, or healthcare research.
• Experience managing or leading clinical studies and cross-functional teams in a matrix environment.
• Strong knowledge of GCP, clinical research regulations, quality systems, informed consent, safety reporting, and data integrity.
• Strong written and verbal communication skills, including scientific and clinical documentation.
• English proficiency is required.

Nice to have

• Master’s or PhD in a scientific or clinical discipline.
• Experience in medical devices, orthopedics, or surgical products.
• People management or matrix leadership experience.
• Experience with regulatory submissions, post-market clinical studies, global trial execution, or investigator-initiated research.
• ACRP, SOCRA, PMP, or other clinical research and project management certification.

Culture & Benefits

• Competitive remuneration package.
• Continuous training and support.
• Award-winning leadership development programs.
• Inclusive, flexible, and accessible working arrangements.
• Equal opportunity environment supporting diversity and inclusion.