Posted: 18 June
The role
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.
Essential Requirements
- 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 standards.
- Demonstrated 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 environment.
- Familiarity with implantable medical devices or hearing health.
- Experience coordinating vendor‐supported medical writing or evidence delivery.
Desired Skills and Experience
- Clinical evidence
- Clinical evaluation
- Scientific writing
- People management
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