Associate Clinical Project Manager – Adjacent Therapies
Cochlear
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) manages clinical investigation projects, ensuring timely delivery, compliance with regulations, and successful outcomes within the Advanced Innovation division, focusing on tinnitus, vestibular, and other neurological disorders.Cochlear is the global market leader in implant hearing solutions. 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. A Cochlear Implant is an electronic device that is surgically implanted under the skin near the ear that restores hearing to those who suffer from severe hearing loss. It’s an incredible piece of engineering and the only product in the world that restores a sense through technology. Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the world in implantable hearing solutions. Our mission is to help more people to hear.The OpportunityCochlear has an opportunity for a full-time, 2 year fixed-term contract Associate Clinical Project Manager based in our Mechelen, Belgium office. In this role, the successful Associate Clinical Project Manager will manage the operational aspects of clinical investigations, ensuring compliance with regulatory standards and achieving project objectives within time, scope, and budget constraints.Responsibilities include:Manage clinical investigations (single-centre, multi-centre, and multi-national) to ensure timely delivery of project objectives.Plan and define investigation timeline, budget, required resources, and vendors.Ensure compliance with Cochlear’s SOPs and applicable regulations.Setup, configure, and archive the electronic Trial Master File (eTMF).Coordinate site selection and qualification activities.Collaborate with data management team to define requirements and review data-related documents.Project controlling and document management for clinical studies.Forecast study budget, track expenditure and manage site and vendor payments.What makes this opportunity unique?This role offers the chance to work at the forefront of neurotechnology innovation, contributing to groundbreaking research in tinnitus, vestibular, and other neurological disorders. The position provides the opportunity to collaborate with a dynamic team, engage in diverse clinical research activities, and explore new business opportunities within a leading global company.About YouTo add value to Cochlear in this role, you’ll be able to demonstrate the following skills and experience:Required SkillsMSc 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 studiesExperience with managing multi-disciplinary projects.Ability to collaborate cross-functionally with internal and external stakeholders.Ability to work independently with a sense of urgency according to the project priorities.Excellent organizational skillsExcellent analytical and conceptual thinking skills with attention to detailStrong interpersonal and communication skills, both verbal and writtenAbility to work in ambiguous environment.IT Skills:Basic knowledge of electronic database systemsProficiency with common business software, such as MS Office applicationsLanguage Skills/ Proficiency:Good knowledge of the English and Dutch languageOther:Willing to travel locally and internationally (
20% of time)
Malines, Anvers
Wed, 24 Jul 2024 22:54:21 GMT
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