Clinical Project Manager - Maternity Cover

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 on a maternity cover basis to develop innovative dental diagnostic solutions.

About the department

You will report to the Head of Clinical & Scientific Affairs and be part of our global Scientific Affairs organization based in Copenhagen, which currently includes 9 people. You will help generate and document 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 Clinical Project Manager, you will work with our Clinical Trial Manager in Scientific Affairs with regard to planning and execution of clinical investigations and clinical surveys, as well as being responsible for the investigation site management, and the resulting clinical investigations together with the Scientific Affairs team and relevant stakeholders, such as colleagues from our Regulatory Affairs, Product Creation, Product Management and Marketing functions.

Your key responsibilities

• Lead the planning, execution, and delivery of pre- and post-market clinical investigations including post-market clinical follow-up in accordance with applicable regulations (e.g., MDR, ISO 14155, GCP)

• Be responsible of clinical investigations documentation (clinical study protocols, informed consent form, patient information sheet, study contracts, application to relevant authorities, study reports and scientific publications)

• Manage study timelines, budgets, and resources to ensure successful project delivery

• Provide support regarding clinical investigation methodology (sample sizes, endpoints, analyses/statistics)

• Ensure compliance with regulatory and ethical standards

• Collaborate closely with internal stakeholders (Regulatory, Product Creation, Product Management, Marketing, Legal) and external partners (CROs, clinical sites)

• Support the organization during internal and external audits

Other responsibilities

If time allows, support the Scientific Affairs team in regard to:

• Provide input to PMCF, Post Market Surveillance (PMS), and vigilance activities based on e.g., risk management, input from customer and complaints

• Provide support to Regulatory Affairs, Product Creation, Product Management, and other 3Shape functions as required

• Contribute to continuous improvement of processes regarding clinical evidence, clinical operations 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

• Experience with managing clinical studies within the medical device industry

• Strong knowledge of EU MDR, ISO 14155, and Good Clinical Practice (GCP). Certification of ISO 14155 or GCP is considered an advantage

• Relevant clinical operation and medical/scientific writing experience in the medical device settings. Statistical understanding is considered an advantage

• Experience with post-market clinical follow-up (PMCF)

• Strong organizational and communication skills, ability to manage multiple projects simultaneously

• 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 25 years. You will be able to work on solutions used by thousands of dental professionals worldwide and improve patient care. 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.

Your contributions and efforts are crucial to our success and by joining us you will experience:

• A vibrant and international environment with social, diverse, and highly skilled and cooperative colleagues - we are more than 40 nationalities in our DK based office

• An attractive healthcare package to keep you fit and well.

• Breakfast every day, and a delicious and healthy lunch cooked by our private chefs.

• We provide a great social work environment with many optional activities and social clubs, ranging from wine & beer, board games, running to bicycle clubs.

• Good work/life balance

• Attractive offices and R&D lab spaces in downtown Copenhagen close to Kgs. Nytorv, Nyhavn, and the Copenhagen Canals.

• Purpose: Help improve dental care on a global scale.

We encourage all relevant applicants to apply. We are committed to celebrating human diversity, and we trust that the best way to reach outstanding business results, is by welcoming diverse people into our community.

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. Twenty years later, 3Shape has 2,000+ 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 LinkedIn.