08 Aug
|
Cochlear
|
City of Sydney
08 Aug
Cochlear
City of Sydney
The Opportunity
Cochlear is seeking a Clinical Evaluation Manager to join the Clinical Evaluation team in our global headquarters located in Sydney. This role has a global scope and reports to the Director, Clinical Evaluation.
The Clinical Evaluation Manager is a critical leadership role responsible for overseeing a global team of specialists who develop and maintain clinical evaluation documentation to support the registration of Cochlear's product portfolio. Combining people leadership with hands-on technical contribution, the role focuses on delivering high-quality, scientifically robust documentation within a high-volume, regulated environment.
You will coach and develop a geographically dispersed team, ensure timely delivery of key clinical assets, and work closely with stakeholders to support compliance, continuous process improvement, and ongoing regulatory requirements.
Key Responsibilities
- Lead the planning, assignment and delivery of clinical evidence and scientific dissemination assets across the Clinical Evaluation team
- Ensure delivery of Clinical Evaluation Plans, Clinical Evaluation Reports, Summaries of Safety and Clinical Performance (SSCPs), systematic literature reviews and manuscripts to agreed timelines and quality standards
- Maintain consistency, traceability and scientific integrity across clinical assets throughout their lifecycle
- Ensure compliance with internal quality procedures and applicable regulatory requirements
- Support audits and inspections through inspection-ready documentation and traceability
- Drive continuous improvement in templates, workflows and documentation practices
- Partner with Regulatory, Quality, Medical Engagement and study teams to align priorities and timelines
- Oversee external writing vendors where required, including direction, review and performance feedback
- Escalate risks and capacity constraints with proposed mitigations
- Degree in life sciences, medicine, audiology, clinical research or a related discipline
- Proven experience in scientific or technical roles, with an understanding of clinical evidence generation, regulatory expectations and/or scientific writing standardsDemonstrated people leadership experience, including coaching, developing and providing constructive feedback to geographically dispersed teams in a matrixed or corporate setting.
- Ability to balance strong attention to detail with delivery in a high-volume, highly regulated environment
- Strong organisational and prioritisation skills, with the ability to oversee multiple workflows and ensure timely delivery within a regulated environment.
Ideal
- Experience delivering clinical evaluation or scientific evidence documentation in a regulated setting
- Familiarity with implantable medical devices or hearing health
- Experience coordinating vendor-supported medical writing or evidence delivery
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📌 Clinical Evaluation and Communications Manager (City of Sydney)
🏢 Cochlear
📍 City of Sydney