Clinical Quality and Compliance Manager

6 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

Our research teams collaborate with top hearing professionals and have more than 100 active research partners in 20 different countries to continuously innovate and provide breakthroughs to those with hearing loss. We are involved in regulated clinical trials and advanced clinical studies designed to improve hearing health.

Working as part of the Global Clinical Innovation and Strategy team, the Clinical Quality and Compliance (CQC) Manager will be responsible for deploying and maintaining quality management processes for clinical research, ensuring compliance with applicable standards and regulations. Working cross functionally you will support and initiate processes and standards which support the execution of high quality, compliant clinical evidence. This role will play a key role in supporting the “advanced innovation team” with a strong focus on early research and developing technologies for the future.

Responsibilities include:
- Maintain compliance CSI Quality Management System (QMS) processes.-
- Conduct and continuously develop clinical research Quality Control (QC) activities.- Conduct and continuously develop clinical research Quality Assurance (QA) activities.

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- Advanced knowledge of clinical research encompassing two or more of the following elements:
- Development of GCP processes.-
- Development or delivery of training on standard operating procedures or GCP.-
- Wide ranging responsibilities in the planning and delivery of risk-based monitoring approachesOversight or management of outsourced activities.-
- Direct audit or CAPA experience.-
- Prior experience or responsibility for the development of standard operating procedures processes and/or delivery of process and/or GCP training-
- Strong attention to detail and organisational skills demonstrated by the ability to manage and deliver multiple projects simultaneously.- Proficiency in MS Office and clinical trial management software and electronic trial master files.- Flexible and adaptable with ability to manage ambiguity and complexity.

Desired Skills- Relevant experience obtained in medical device clinical research or in contexts external to Cochlear.- Previous success in the delivery of relevant projects, such as implementation or integration of systems for management of clinical investigations.- Experience with evaluation and selection of vendors for outsourcing or resourcing- Experience with different electronic platforms for clinical trial or project management- Flexible and adaptable with ability to manage ambiguity and complexity.

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 f

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