Regional Clinical Research Lead – Orthopedic Devices

Johnson & Johnson; Sydney; On-site; AUD 140,000 - 210,000; Full time

Benefits offered by this job

Competitive remuneration

Continuous training

Inclusive working arrangements

Job summary

DePuy Synthes is seeking a Manager, Clinical Research in North Ryde, Australia to lead regional clinical programs and coordinate with the global clinical team. The role focuses on evidence generation for orthopedic devices and ensures alignment with regulatory and patient-outcome objectives.

The ideal candidate has hands-on device clinical research experience, strong cross-functional communication, and a track record managing studies, vendors, and sites in a matrix environment.

Qualifications

• 6-8 years of progressive clinical research or clinical operations experience.
• Experience managing medical device clinical studies across multiple phases.
• Knowledge of ISO 14155, GCP, ethics and safety reporting.
• Experience with global and local cross-functional teams.
• Experience managing CROs, vendors, clinical sites and timelines.

Responsibilities

• Serve as Australia-based clinical research lead and interface with global team to inform plans.
• Identify regional evidence needs and translate into global strategy recommendations.
• Lead or support local execution of medical device clinical studies (feasibility, start-up, site management).
• Manage CRO and vendor activities, including scope, budget, timeline, and quality deliverables.
• Build relationships with investigators, sites, registries, and networks.
• Support AOANJRR and other registries with data requests and analyses.
• Ensure compliance with ISO 14155, ICH GCP, ethics, and regulatory requirements.
• Develop study plans, projections, milestones, monitoring approaches, and risk mitigation.
• Support audit readiness and timely CAPAs for study findings.
• Provide status reports and handoffs across time zones to align with global team.

Skills

Clinical research

CRO management

Medical devices

Regulatory knowledge

Stakeholder management

Communication

Job description

DePuy Synthes is seeking a Manager, Clinical Research in North Ryde, Australia to lead regional clinical programs and coordinate with the global clinical team. The role focuses on evidence generation for orthopedic devices and ensures alignment with regulatory and patient-outcome objectives.

The ideal candidate has hands-on device clinical research experience, strong cross-functional communication, and a track record managing studies, vendors, and sites in a matrix environment.