Clinical Project Manager (MedTech)

TL;DR

Clinical Project Manager (MedTech): Planning and executing pre- and post-market clinical investigations for dental diagnostic solutions with an accent on regulatory compliance and clinical evidence generation. Focus on managing study timelines, coordinating with CROs, and ensuring adherence to MDR and ISO standards.

Location: Onsite in Copenhagen, Denmark

Company

hirify.global is a global MedTech company specializing in 3D scanning and CAD/CAM solutions for the dental and hearing industries.

What you will do

• Lead the planning, execution, and delivery of pre- and post-market clinical investigations, including post-market clinical follow-up.
• Develop and manage clinical documentation such as study protocols, informed consent forms, and scientific publications.
• Manage study timelines, budgets, and resources to ensure successful project delivery.
• Collaborate with internal stakeholders (Regulatory, Product Management, Marketing) and external partners like CROs.
• Provide expertise on clinical investigation methodology, including sample sizes and statistical analysis.
• Support the organization during internal and external audits to ensure regulatory compliance.

Requirements

• Master's degree in a scientific field (PhD preferred).
• Experience managing clinical studies within the medical device industry.
• Strong knowledge of EU MDR, ISO 14155, and Good Clinical Practice (GCP).
• Experience with post-market clinical follow-up (PMCF) and medical/scientific writing.
• Fluent written and oral English.
• Must be based in or able to work from Copenhagen, Denmark.

Culture & Benefits

• Vibrant international environment with colleagues from over 40 nationalities.
• Attractive healthcare package.
• Daily breakfast and healthy lunch prepared by private chefs.
• Active social work environment with various clubs (wine, beer, board games, running, cycling).
• Strong emphasis on work-life balance.
• Modern offices and R&D lab spaces located in downtown Copenhagen.