Clinical Operations Manager, China
Job no: 611862
Work type: Permanent
Categories: Clinical Studies, Quality & Regulatory, Asia Pacific, People Manager
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. 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 people to Hear Now. And Always.
Cochlear China, one of the fastest growing division of Cochlear Ltd, has a direct market presence. Our implantable hearing device portfolio includes cochlear implant systems (Nucleus®) and bone conduction implant systems (Baha®)
Cochlear now has a unique opportunity for an experienced Clinical Studies Operations Manager to be based in our Beijing office. In this role, you will ensure that local and global regulatory requirements for the conduct of clinical investigations within Greater China are addressed and support the implementation of clinical investigation quality management processes.
- Participation in global clinical investigation operational initiatives.
- Development, maintenance and deployment of supplemental local quality management processes applicable to the conduct of clinical investigations within the Greater China area to ensure regulatory compliance.
- Local deployment and oversight of clinical investigation quality management processes and systems through development and execution of training, metrics, audits etc.
- Supporting the execution of clinical investigations through document reviews and translations.
- Management of local Clinical research Associate and Clinical Project Management staff.
- Vendor selection and management for outsourced clinical investigation responsibilities.
- Raising the profile of clinical studies operations locally by collaboration and participation in both regional and global initiatives with internal stakeholders.
You Bring Your Skills and Experience
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:
- Prior experience and responsibility for the development of processes and the implementation of integrated clinical investigation standard operating procedures
- Extensive working knowledge and application of Good Clinical Practice through experience in delivery of process and/or training
- Subject matter expert contributor to relevant quality or efficiency measures, such as prior audit and/or CAPA experience, management dashboard reporting
- Experience with evaluation and selection of vendors for outsourcing or resourcing
- Demonstrated experience in writing and/or review of standard operating procedures
- Tertiary degree (min. Bachelor degree) in health sciences, nursing, biomedical sciences, pharmacy, pharmacology, or related discipline.
- Excellent interpersonal and communication skills with internal stakeholders and external customers
- Strong attention to detail and organisational skills
- Proficiency in MS Office
- Flexible and adaptable with ability to manage ambiguity and complexity
- Experience in medical device clinical research with previous success in the delivery of relevant projects, such as integration, rollout or leadership in application of systems for management of clinical investigations, clinical evidence or clinical risk management.
In return, you will have the unique opportunity to work in a multinational organization engaged in the delivery of life changing technology. As you manage clinical studies operations for China, you will be able to share in the excitement of bringing new technologies to market and seeing the profound impact that it has in the lives of the hearing impaired.
Working for Cochlear:
Cochlear is the global leader in implantable hearing solutions. The company has a global workforce of more than 4,000 people worldwide and invests more than AUD$160 million each year in research and development. Over 550,000 people across more than 100 countries now experience hearing as a recipient of a Cochlear hearing solution.
Cochlear can offer:
- The Work - A high impact job supporting world leading technology
- The Organisation – A global leader in active implantable medical device hearing technology
- The Opportunity – To make a difference to the quality of people’s lives
As a world-leader in innovative medical devices, Cochlear encourages continuous learning for employees. Visit www.cochlearcareers.com for more information.
Advertised: China Standard Time
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