Clinical Project Manager
Job no: 614882
Work type: Permanent
Categories: Clinical Studies, Asia Pacific, Oceania, Individual Contributor
- Change people’s lives and love what you do!
- Sydney based HQ, Global medical device Icon
- Macquarie Park based role with parking and flexible working arrangements
Cochlear is an ASX Listed success story and develops world-leading medical devices that help people hear. As a top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other.
We are looking for a Clinical Project Manager to join our Global Head Office in Sydney to work in a full time, permanent capacity.
In this role you will be responsible for the management of all aspects of Clinical Trial activities for assigned projects on a regional or global basis. In conjunction with the Director Clinical Operations, you will be responsible for achieving the successful delivery of Cochlear clinical team activities at the project level by meeting company and regulatory requirements according to time, quality and budget constraints.
Key accountabilities include:
- Overall development of clinical trial protocols to support our State of the Art products in development
- Proactively manage project level operational aspects of Clinical Trials including management of trial timeline, budget, resources and vendors
- Provide efficient updates on trial progress to the Director Clinical Operations with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation
- Lead sponsor study startup process, including but not limited to conduct of the trail kick-off meeting, the set up of trial master file, site selection and finalisation of site and Clinical Trial agreements and budgets
- Other duties as required
- Bachelor degree in Biology, Health, Life Sciences
- Significant Clinical Research Associate experience
- Clinical project management experience
- Experience writing study protocols, especially with adaptive design protocols
- Expert understanding of Good Clinical Practice and other relevant regulatory requirements across FDA, TGA and EMR?
- Extensive background in global or regional Medical Device studies
- Ideally experience working in matrix structures
Be part of something purposeful and APPLY NOW by clicking on the link below and see your career grow!
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. Cochlear is the global market leader in implantable hearing solutions including cochlear implant systems (CI) and bone anchored hearing aids (Baha™).
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.
Advertised: AUS Eastern Standard Time
Anticipated Application Closing: AUS Eastern Standard Time
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