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Senior Clinical Project Manager / Team Lead - job post

Cochlear Ltd
3.3 out of 5
405 31 Göteborg
Heltid
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  • Heltid

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405 31 Göteborg

Fullständig jobbeskrivning

The Senior Clinical Project Manager / Team Lead manages and executes sponsored multi-centre clinical trials, ensuring compliance with regulations, overseeing study documentation and site activities, and acting as the primary liaison between clinical trial sites and the sponsor. This role also involves leading a clinical operations team to drive process improvements and ensure high standards of study execution.

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 Opportunity

Cochlear has an opportunity for a full time Senior Clinical Project Manager / Team Lead based in our Goteborg, Sweden office. In this role, the successful Senior Clinical Project Manager / Team Lead will be responsible for the execution of sponsored multi-centre clinical trials in the pre- and post-market phase. The Senior CPM ensures compliance with applicable SOPs, global and local regulations including European Medical Device Regulation (EU MDR), ISO14155, International Committee on Harmonization (ICH), Good Clinical Practice (GCP), and EU General Data Protection Regulation (GDPR). This role will lead and develop a team of Clinical Project Managers and Clinical Research Associates.


Responsibilities include:

  • Manage portfolio of Cochlear sponsored clinical investigations in EMEA.
  • Provide input and review into the development of initial Clinical Investigation Protocol (CIP) and final Clinical Investigation Report (CIR).
  • Liaise with Clinical Compliance team and Clinical Research Associates (CRA) to create and implement required study documentation and plans.
  • Negotiate multicentre, site-specific contracts relevant to the conduct of the study including budget negotiations.
  • Oversee Site Qualification, Site Initiation, Interim, and Close-out Monitoring Visits.
  • Act as primary contact between clinical trial sites and sponsor for all study-specific needs.



  • What makes this opportunity unique?

    This opportunity allows you to contribute to the success of the clinical studies and research team during a period of growth and expanding capabilities. It offers the chance to work in an international environment, across organization boundaries, and learn about the development and launch of advanced Implantable Hearing Solutions. You will also gain professional experience working as a project manager within a Clinical Research department and have visibility to project management capability.



    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:



    Education:

    • MSc degree in life sciences or equivalent


    Work Experience:

      • 5 years clinical studies experience as Clinical Project Manager, preferably involving medical devices.
    • Proven knowledge of Medical Device Regulations on conduct of clinical studies (ISO14155, GCP, EU MDR and GDPR)
    • Solid experience in data collection and analysis from human subjects
    • Proven experience with managing multi-disciplinary projects.
    • Proven evidence of writing and reviewing scientific publications
    • Proven experience with work in close relationship to clinics and research centres.
    IT Skills:

    • Proficiency with common business software, such as MS Office applications
    • Proficient user experience with electronic data capture (EDC) and electronic trial master file (eTMF) systems, project planning and managing and maintain budgets.
    Soft Skills:

    • Previous experience as a people manager is a bonus.
    • 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:

    • Business level Swedish & English


    Development Value of this role:

    • Contribute to the success of the clinical studies and research team during a period of growth and expanding capabilities.
    • Opportunity to work in an international environment.
    • Opportunity to work across organization boundaries.
    • Opportunity to learn about the development and launch of advanced Implantable Hearing Solutions
    • Opportunity to consolidate experience working in an international hi-tech company at the leading edge of implantable hearing solutions.
    • Opportunity to gain professional experience working as project manager within a Clinical Research department.
    • Visibility to project management capability.


    Region-specific Requirements:

    • Willing to travel locally and internationally (20% of time)


    Cochlear's mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a life full of hearing. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We collaborate with the industry's best clinical, research and support networks. That's why more people choose Cochlear than any other hearing implant company. Learn and grow with us as we tackle the most complex challenges in helping more people to hear and experience life's opportunities.

    If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.

    #CochlearCareers



    How we recognise your contribution

    We want Cochlear to be a place where our people truly enjoy coming to work. Through our internal programs and employee benefits, we aim to create an environment where our people will feel value and supported. Whether your focus is on continuous learning, professional development or simply finding an environment which enables you to thrive whilst balancing family or personal life commitments, then we have several programs in place to support you.

    For more information about Life at Cochlear, visit www.cochlearcareers.com

    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.
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