Clinical Project Manager

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Are you ready to pursue your career within disruptive MedTech working with 3D scanners and software medical devices in a global setting? We are looking for a Clinical Project Manager to join us in developing innovative dental diagnostic solutions. 

About the department

You will report to the Head of Scientific Affairs and be part of our growing global Scientific Affairs organization based in Copenhagen, which currently includes 5 people. You will help with documenting the clinical evidence for the future of digital dentistry in collaboration with the entire organization and enable people across the world to enjoy better lives.

Your role in 3Shape 

As our new Clinical Project Manager, you will support our Clinical Research team in Development planning and execution of early clinical investigations as well as being responsible for the clinical development plan and the resulting clinical investigations together with the Scientific Affairs team and relevant stakeholders, such as CROs and colleagues from our Development, Regulatory Affairs, Product Management and Marketing functions. Since this position is a new role in 3Shape, you will be able to impact the way 3Shape establishes the clinical development framework in a global context and propose ideas for alternative pathways.

Your key responsibilities

  • Plan and facilitate pre-market and post-market clinical investigations on medical devices according to ISO 14155:2020 and/or local requirements
  • Provide support to clinical investigations documentation (clinical study protocols, informed consent form, patient information sheet, application to relevant authorities, study reports and scientific publications)
  • Provide support regarding clinical investigation methodology (sample sizes, endpoints, analyses/statistics)
  • Interact with clinical research organizations (CRO), competent authorities, ethics committees and external partners on join projects
  • Act as the point of contact in the interface between 3Shape and a CRO
  • Establish the required SOPs and templates in collaboration with stakeholders
  • Support the organization during internal and external audits

Other responsibilities

If time allows, support the Scientific Affairs team regarding:

  • Preparation and maintenance of Clinical Evaluation Plans and Reports
  • Provide input to Post Market Surveillance, PMCF, and vigilance activities based on e.g., risk management, input from customer and complaints
  • Provide support to Regulatory Affairs, Development, Product Management, and other 3Shape functions as required
  • Contribute to continuous improvement of processes regarding clinical evidence and PMS based on knowledge of applicable regulations, guidance’s, and best practices Answer questions from health authorities and from company affiliates/resellers regarding clinical evidence

Your profile

We are looking for a person with:

  • Master’s degree within a scientific field, preferably a PhD degree
  • Relevant clinical operation and medical/scientific writing experience (including preparation of scientific articles) in the medical device settings. Statistical understanding is considered an advantage
  • Understanding of EU and global medical device regulations/directives, including ISO 14155:2020
  • Structure to drive processes forward
  • Excellent planning, cooperation, and communication skills
  • Fluent in written and oral English

As a person, you are a good team player with strong interpersonal skills who thrives working with multiple stakeholders and partners in an international setting, both internally and externally. Also, you have the ability to successfully handle multiple tasks while managing tight deadlines.

We offer

This is an opportunity to become part of an exciting MedTech company and to make a real impact. With us you will be part of the success that 3Shape has created over the past 20 years. You will be able to work on solutions used by thousands of dental professionals worldwide and improve patient care. Your contributions and efforts are crucial to our success and by joining us we offer you:

  • An attractive office environment in downtown Copenhagen, next to Kongens Nytorv
  • An inspiring work environment in an informal atmosphere, with social, diverse, and highly skilled colleagues
  • A professional challenge in a dynamic, globally oriented business environment
  • Empowerment and influence over own tasks
  • Work/life balance
  • A healthcare package to keep you fit and well, and fresh and delicious lunch cooked by our private chef
  • We provide a great social work environment with many optional activities and employee clubs, ranging from wine, board games to bicycle clubs.

Get in touch now!

We have an exciting journey ahead of us and if you want to be part of this don’t hesitate to apply for this position in one of Denmark’s most successful and fastest-growing MedTech companies. Applications will be processed continuously. We do expect to close our search for this position as soon as possible.

We encourage all relevant applicants to apply. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status. All qualified applicants will be given equal opportunity and the selection is based on job-related factors.

About us

3Shape started with a simple idea - to make 3D scanning better. First, we applied it to the hearing industry, then we succeeded in dentistry. Now, twenty years later, 3Shape is 1,700+ employees globally. With the help of dental professionals and amazing colleagues we’re creating award-winning scanning and CAD/CAM solutions to change dentistry together! Together, we contribute to a better world. Experience the everyday #lifeat3Shape across the globe on Facebook.

Or, know someone who would be a perfect fit? Let them know!

DK - Copenhagen

Holmens Kanal 7
1060 København Directions View page

Our biggest assets are our people and culture 💗

Life at 3Shape is great! We bring passion and talent to work every day to innovate for superior patient care. 3Shape is built on a culture of thinking differently and being innovative when solving challenges. We embrace new ways to exchange ideas with colleagues across departments and think and work in an agile way. Experience the everyday #lifeat3Shape across the globe on Facebook. 

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