Job Title: Clinical Studies Project Manager
Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As the top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear 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.
About the role
In order to help Cochlear bring new products to market, we are recruiting for a Clinical Studies Project Manager in our Americas head office based in Centennial, CO.
To be successful in this role you’ll be an Audiologist based in Denver, Colorado who is able to partner with premier research institutions and collaborate on ground breaking research involving implantable hearing technology. You’ll work collaboratively with individuals across the organization including Clinical, Research & Development, Marketing, Regulatory, and Legal to manage multi-center Cochlear sponsored research projects. This manager role is responsible for managing FDA regulated and non-significant risk clinical trials investigating Class II and Class III medical devices according to specified timelines, internal standards, and applicable regulations.
In this role you'll have the opportunity to make a significant contribution to Cochlear's successful history of innovation by applying your knowledge of implantable hearing technology, project management experience, and clinical research. You'll know you've been successful in this role when you've contributed to Cochlear’s research presence as the market leader.
- Collaboration with Global colleagues as well as Regional Clinical, Marketing and Health Economics to define investigational plans
- Management of Significant Risk (SR) and Non-Significant Risk (NSR) studies
- Monitoring of clinical studies as needed with appropriate follow-up
- Data review and analysis including adverse event reporting
- Preparation of progress reports, updates and presentations as required
- Compliance with internal and external applicable standards and procedures
- Good clinical and documentation practices
To add value to Cochlear in this role you'll be able to demonstrate the following skills and experience in your application and at interview:
- Advanced degree in Audiology, Hearing Science or associated field
- Minimum 5 years clinical trial experience with Class II or III devices
- Strong project management skills
- Strong in Microsoft based software (Microsoft Word, Project and Excel)
- Statistical analysis software experience (SAS, SPSS or Sigma Plot)
- Excellent verbal and written communication skills as well as industry related presentation experience
- Ability to travel 1 – 2 times per month
Working at Cochlear Americas:
- Work with dedicated and passionate colleagues to help more people hear
- Diverse culture
- Highly collaborative team environment
- Opportunities for growth and development
- Competitive salary, benefits and bonus
- State of the art facility with great work/life balance conveniences (daily on-site coffee barista, onsite gym, dry cleaning services and more)
Apply now by completing your application form online. Cochlear is an equal employment opportunity organization. Applicants must meet the job specific application criteria to be considered.
Cochlear pioneered and is the global leader in the research and development, manufacture and marketing of implantable hearing solutions. Cochlear’s global headquarters is located in Sydney, Australia where we design and manufacture the leading cochlear implant devices in the world. A success story in the commercialization of R&D, Cochlear has a 60% share of the global market, employs more than 2,500 people worldwide, operates directly in over 20 countries and sells in over 100 countries. Over 250,000 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 Organization – A global leader in active implantable medical device hearing technology
- The Opportunity – To make a difference to the quality of people’s lives and grow your career
As a world-leader in innovative medical devices, Cochlear encourages continuous learning for employees. Visit www.cochlear.com/careers for more information.
Apply now by completing your application form online. Applicants must meet the job specific application criteria to be considered.
Cochlear Americas is an Equal Opportunity, Affirmative Action Employer and provides equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, marital status, veteran status, or any other characteristic protected by federal, state or local law. In addition, Cochlear will provide reasonable accommodations for qualified individuals with disabilities. If you require accommodation with completing the online application, please contact us via web or phone at 303-264-2349. #cochlearcareers