Manager, Clinical Research
Core
Australia-based clinical research lead supporting evidence generation and clinical study execution for DePuy Synthes' orthopedic medical device portfolio.
Role type
Manager, Clinical Research (People Leader)
Builds
High-quality clinical evidence for orthopedic medical devices to support patient outcomes, regulatory requirements, and business needs.
Domain
Healthcare / Medical Devices / Orthopedics
Required skills
Medical device clinical research execution, CRO and vendor management, clinical site and investigator relations, regulatory compliance (ISO 14155, ICH GCP), cross-functional stakeholder management, risk mitigation, study documentation and audit readiness.
Preferred skills
Orthopedics/joint replacement/surgical device experience, registry data analysis (e.g., AOANJRR), post-market surveillance, matrix leadership.
Technologies
ISO 14155, ICH GCP, AOANJRR
Responsibilities
Serve as primary interface with global clinical team for regional evidence needs; identify evidence gaps and translate into global strategy recommendations; lead local execution of clinical studies (feasibility, start-up, enrollment, monitoring, close-out); manage CRO and vendor activities; build relationships with orthopedic investigators and clinical sites; support registry interactions and data analysis; ensure compliance with regulatory and quality standards; provide status reporting and decision support to global team.
Seniority
Manager, hands-on IC with people leadership responsibilities
