Clinical Development Manager

2 months ago

Sydney, Australia Cochlear Ltd Full time

Cochlear is the global market leader in implant hearing solutions. Cochlear's mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. A Cochlear Implant is an electronic device that is surgically implanted under the skin near the ear that restores hearing to those who suffer from severe hearing loss. It’s an incredible piece of engineering and the only product in the world that restores a sense through technology. Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the world in implantable hearing solutions. Our mission is to help more people to hear.

The Opportunity

Cochlear has an opportunity for a full-time Clinical Development Manager based in our Macquarie office. In this role, the successful Clinical Development Manager will play a critical role in creating, developing, and implementing clinical strategies to ensure products not only achieve regulatory approval but are also clinically impactful throughout their lifecycle.

Responsibilities include:

- Develop and contribute to clinical program strategies that support product approval and lifecycle.
- Collaborate with cross-functional teams to align portfolio strategies with business objectives.
- Design clinical investigations, oversee study documentation, and maintain clinical strategies.
- Support training initiatives to ensure compliance and alignment across study sites.
- Engage in data collation, analysis, and clinical alignment to bridge knowledge gaps.
- Advocate for portfolio strategies and optimise collaboration across project teams.

What makes this opportunity unique?

This role empowers you to work at the forefront of clinical research within the medical devices industry, focusing on hearing solutions. Collaborate with cross-functional and global teams, driving strategies that help Cochlear deliver life-changing products with measurable impact worldwide.

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:

- Background in the medical device/pharmaceutical industry with minimum 3 years of relevant experience.
- Degree level education (preferably health related or science).
- Proven experience as a Clinical Project Manager, Clinical Research Specialist, or Research Audiologist in medical devices.
- Expertise in study design and knowledge of relevant regulations (e.g., ISO13485, ISO14155, MDR, FDA21CFR820).
- Strong report writing and technical communication skills.
- Resilient, resourceful, and solution-oriented.
- Familiarity with data management and interpretation.

Ideal:

- Experience in writing clinical protocols, investigation reports, and planning evidence strategies for regulatory submissions.
- Commercial acumen and knowledge of hearing science practices.

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 life full of hearing. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We collaborate with the industry’s best clinical, research and support networks. That’s why more people choose Cochlear than any other hearing implant company. Learn and grow with us as we tackle the most complex challenges in helping more people to hear and experience life’s opportunities.

CochlearCareers

How we recognise your contribution

We want Cochlear to be a place where our people truly enjoy coming to work. 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.

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. We offer flexible working arrangements, and we understand flexibility is not the same for everyone. We're open to a conversation about what flexibility means for you.

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