Clinical Project Manager - Maternity Cover Job at 3Shape (Copenhagen)

Job Description

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.

Job Responsibility

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
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

Requirements

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)
Relevant clinical operation and medical/scientific writing experience in the medical device settings
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
Good team player with strong interpersonal skills
Ability to handle multiple tasks while managing tight deadlines

Nice to have

Certification of ISO 14155 or GCP
Statistical understanding

What we offer

Vibrant and international environment with social, diverse, and highly skilled and cooperative colleagues
Attractive healthcare package
Breakfast every day
Delicious and healthy lunch cooked by private chefs
Great social work environment with many optional activities and social 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

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Clinical Project Manager - Maternity Cover

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