Clinical Evaluation Manager
On-site · Sydney, New South Wales, Australia
Job Summary
Clinical Evaluation Manager leading a global Clinical Evaluation team to develop and maintain clinical evaluation documentation for regulatory submissions. Responsible for planning, assigning, and delivering clinical evidence, Clinical Evaluation Plans, Clinical Evaluation Reports, Summaries of Safety and Clinical Performance (SSCPs), systematic literature reviews, and manuscripts to tight timelines while ensuring scientific integrity and regulatory compliance. Partners with Regulatory, Quality, Medical Engagement and study teams; oversees external writing vendors; drives process improvements; coaches and develops geographically dispersed staff; supports audits/inspections, and ensures traceability across documentation within a regulated environment.
Required Qualifications
- Degree in life sciences, medicine, audiology, clinical research or a related discipline
- Proven experience in scientific or technical roles with understanding of clinical evidence generation and regulatory expectations
- Demonstrated people leadership experience managing geographically dispersed teams
- Ability to balance attention to detail with delivery in a high-volume, regulated environment
- Strong organizational and prioritization skills with ability to oversee multiple workflows
- Ideal: experience delivering clinical evaluation or scientific evidence documentation in a regulated environment
- Ideal: familiarity with implantable medical devices or hearing health
- Ideal: experience coordinating vendor-supported medical writing or evidence delivery
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