Job Description
Please submit your application as soon as possible, as we reserve the right to close this advertisement at any time.
Cochlear’s mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a world full of sound. We aim to transform the way people understand and treat hearing loss and innovate to connect people with future technologies. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. Learn and grow with us as we tackle the most complex challenges in helping more people to experience a lifetime of hearing.
The Opportunity
Cochlear has an opportunity for a full-time permanent Clinical Operations Manager based in our Sydney office. In this role, the successful Clinical Operations Manager will lead a team of Clinical Research Associates and Clinical Trial Assistants while also acting as a Senior Clinical Project Manager, ensuring the successful delivery of Cochlear-sponsored clinical investigations in line with regulatory standards and business strategy.
Leading and mentoring CRAs and CTAs to deliver high-quality clinical research outcomes.
Managing resources, timelines and budgets across clinical operation plans.
Ensuring compliance with ISO 14155, ICH-GCP, local regulations and SOPs.
Overseeing execution of pre- and post-market clinical investigations.
Driving KPI tracking, reporting and continuous improvement initiatives.
Managing vendor relationships and supporting audits and inspection readiness.
What makes this opportunity unique?
This role offers a rare combination of people leadership and hands-on clinical project ownership within a global medical device organisation. You’ll play a critical role in delivering life-changing hearing solutions while working across diverse teams and geographies, influencing both strategy and execution.
About You. As we grow our operations, we are looking for people who share our passion for delivering quality hearing solutions to our customers. To add value to Cochlear in this role, you'll be able to demonstrate the following skills and experience:
Essential:
Significant experience in clinical investigations within medical devices or pharma.
Strong knowledge of ICH-GCP, ISO 14155:2020 and regulatory requirements.
Proven leadership experience in building and developing high-performing teams.
Experience with EDC, CTMS and eTMF systems.
Excellent organisational, problem-solving and communication skills.
Ability to manage multiple projects and stakeholders simultaneously.
Ideal:
Experience with CRO selection and vendor management.
Exposure to study design, reporting or quality support activities.
Experience working on global, cross-functional clinical programs.
Ability to influence stakeholders and drive continuous improvement initiatives.
If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.
#CochlearCareers
How we recognise your contribution
At Cochlear we value and welcome the unique contributions, perspectives, experiences, and backgrounds of our employees and aim to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to realise their full potential. Through our internal programs and employee benefits, we aim to create an environment where our people will feel value and supported. Whether your focus is on continuous learning, professional development or simply finding an environment which enables you to thrive whilst balancing family or personal life commitments, then we have several programs in place to support you.
For more information about Life at Cochlear, visit www.cochlearcareers.com