Clinical 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 continue to bring new products to market and improve hearing outcomes, we are recruiting for a Clinical Project Manager to support Advanced Innovation research in our Americas head office based in Centennial, Colorado.
To be successful in this role, you will be able to manage internal and external early-stage clinical studies on medical devices. You will work collaboratively with clinicians, scientists, and engineers to help test novel stimulation methods to make our devices work better. You will also work with global and regional clinical operations managers to ensure compliance with procedures and seek ways to improve operational efficiency. This role is responsible for achieving high quality investigational outcomes and overseeing regulatory requirements.
In this role, you will have the opportunity to make a significant contribution to Cochlear's successful history of innovation by applying your knowledge of Good Clinical Practice and clinical research coordination. Ideally you also have an understanding of clinical audiology and cochlear implants. By managing early-stage clinical studies, you will have a unique opportunity to contribute to product design and clinical evaluation within a medical device company. You will know you have been successful in this role when you have become an integral part of a multi-disciplinary team that develops and evaluates promising new technologies.
- Manage early-stage clinical investigations to ensure success of project objectives.
- Develop and maintain relevant documents to plan, execute, and close out investigations.
- Ensure compliance with Cochlear’s clinical standard operating procedures and all applicable regulations.
- Maintain regulatory files, training and delegation records, subject files, and investigational device accountability records.
- Collaborate with internal and external team members to facilitate smooth regulatory submission and reporting to IRBs.
- Drive subject accrual, receipt of clinical data within specified timelines, and timely reporting of adverse events.
- Enter, review, and verify investigational data and applicable medical records.
- Conduct investigational site visits and actively communicate with sites to ensure study compliance and provide support as needed.
- Prepare clinical study progress reports to FDA and other regulatory bodies as required.
To add value to Cochlear, in this role you will be able to demonstrate the following skills and experience in your application and at interview:
- 2 or more years clinical research experience in an industry setting
- Bachelor’s Degree or higher within Health Sciences, Communication Sciences and Disorders, Nursing, general science, or equivalent. Knowledge of cochlear implants and/or audiology is desirable but not required.
- Ability to collaborate cross-functionally with internal and external stakeholders including clinicians, engineers, scientists, clinical site investigators, data management, global clinical affairs and R&D teams
- Willingness and ability to span multiple sponsor and investigator roles
- Proficient in Good Clinical Practice and applicable medical device regulations; CRA certification is preferred.
- Strong in Microsoft based software (Microsoft Word, PowerPoint, and Excel)
- Excellent verbal and written communications skills
- Excellent organizational skills and attention to detail
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 (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.