Associate Clinical Project Manager

at  Cochlear Ltd

Change people’s lives and love what you do! Cochlear 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. 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.
The Associate Clinical Project Manager (aCPM) is responsible for managing the operational aspects of clinical investigations within the Advanced Algorithms, Audiology & Clinical department at Cochlear. This role involves overseeing the planning, execution, and close-out phases of clinical projects, ensuring they meet company and regulatory standards. The aCPM collaborates closely with the Clinical Portfolio Manager and other team members to deliver high-quality clinical outcomes, while also managing site-based responsibilities, monitoring trial sites, and ensuring compliance with relevant procedures and regulations.
The Opportunity
Cochlear has an opportunity for an Associate Clinical Project Manager based in our Cochlear Technology Centre in Mechelen, Belgium. In this role, the successful Associate Clinical Project Manager will manage the operational aspects of clinical investigations, ensuring projects are delivered on time, within budget, and in compliance with regulatory standards, while collaborating closely with cross-functional teams to support the maturation of new audiological technologies.

Responsibilities include:

• Proactively manage project-level operational aspects of clinical investigations, ensuring timely delivery of project objectives within budget and scope.
• Plan and define investigation timelines, budgets, required resources, and vendors while ensuring compliance with SOPs and regulations such as GCP and ISO14155.
• Set up, configure, and maintain the electronic Trial Master File (eTMF), coordinating site selection and communication.
• Monitor the conduct of clinical trials, ensuring compliance with established standards and protocols, and provide clear communication to stakeholders.
• Oversee day-to-day operations of clinical investigations, including maintaining essential documentation and preparing for internal monitoring visits.
• Provide efficient updates on study progress regarding budget, timeline, and quality standards, while escalating potential risks to management.
• Seek efficiencies in study execution, contributing to process improvements and innovation within the team.

What makes this opportunity unique?
This role offers significant development value by providing opportunities to enhance project management skills within the clinical research field, particularly in the areas of compliance with medical device regulations and Good Clinical Practice. The Associate Clinical Project Manager will gain hands-on experience in managing clinical investigations, collaborating with cross-functional teams, and contributing to the development of innovative audiological technologies. Additionally, this position allows for professional growth through exposure to a global work environment and the opportunity to influence process improvements and efficiencies in clinical study execution.
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:

Minimum

• Education/expertise:
• MSc degree in medicine, biomedical sciences or related field. Knowledge of Medical Device Regulations on conduct of clinical studies (ISO14155, GCP)
• Knowledge of country specific regulations on the conduct of clinical studies
• Experience with managing multi-disciplinary projects
• Ability to collaborate cross-functionally with internal and external stakeholders
• Ability to work independently with a sense of priority
• Excellent organizational skills
• Excellent analytical and conceptual thinking skills with attention to detail
• Strong interpersonal and communication skills, both verbal and written
• Work Experience:
• Experience in project controlling and document management for clinical studies
• IT Skills:
• Basic knowledge of electronic database systems
• Proficiency with common business software, such as MS Office applications
• Soft Skills:
• Affinity with clinical research in an industry setting or Clinical Project Manager experience
• Team player with the ability to work in a multi-disciplinary environment
• Ability to work independently with a sense of priority
• Demonstrated organization and planning skills
• Strong interpersonal and communication skills, both verbal and written
• Excellent analytical and conceptual thinking skills with attention to detail
• Language Skills/ Proficiency:
• Good knowledge of the English language
• Other:
• Willing to travel locally and internationally (<20% of time)

Ideal

• Education: PhD in Audiology or related field
• Work Experience:
• Research expertise in the field of hearing
• Scientific experience
• 3 -5 years’ experience in Clinical Studies or related field
• Qualified knowledge of Medical Device Regulations on conduct of clinical investigations (ISO14155, GCP, EU MDR, GDPR)
• Experience in a global, cross-functional environment including remote partners
• Knowledge of the implantable hearing solutions field as well as familiarity with Cochlear’s products
• IT Skills:
• Master in planning, tracking and communication software, such as MS Project, JIRA and Confluence
• Knowledge of electronic database systems (EDC)
• Language Skills/ Proficiency:
• Good knowledge of additional European languages

What we offer
An attractive remuneration package and flexible extra-legal benefits
An extensive onboarding and training program
An enjoyable work environment with attention to life-work balance and homeworking
A stimulating environment with growth opportunities and opportunity to meet multi-disciplinary colleagues across the globe
This is your chance to be part of a premier organization with a great culture, working in a dynamic, growing and rapidly evolving environment to deliver outstanding results that benefit our customers every day. Be part of something purposeful and APPLY now by clicking on the link below and see your career grow!
Cochlear Summary
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 is the global market leader in implantable hearing solutions including cochlear implant systems (CI) and bone anchored hearing aids (Baha™).
Equal opportunities
Cochlear is committed to providing equal opportunities to avoid unlawful discrimination on the grounds of race, sex, disability, sexual orientation, religion/belief or age. In line with our corporate ethics and statutory obligations we strive to ensure that the work environment is free of harassment and bullying and that everyone is treated with dignity and respect - this is an important aspect of ensuring equal opportunities in employment.

• Proactively manage project-level operational aspects of clinical investigations, ensuring timely delivery of project objectives within budget and scope.
• Plan and define investigation timelines, budgets, required resources, and vendors while ensuring compliance with SOPs and regulations such as GCP and ISO14155.
• Set up, configure, and maintain the electronic Trial Master File (eTMF), coordinating site selection and communication.
• Monitor the conduct of clinical trials, ensuring compliance with established standards and protocols, and provide clear communication to stakeholders.
• Oversee day-to-day operations of clinical investigations, including maintaining essential documentation and preparing for internal monitoring visits.
• Provide efficient updates on study progress regarding budget, timeline, and quality standards, while escalating potential risks to management.
• Seek efficiencies in study execution, contributing to process improvements and innovation within the team