Clinical Research Manager AI (Molndal, SE, NA) chez Dentsply Sirona USA: Dental products and technologies USA

Requistion ID: 81811 

Clinical Research Manager AI

Do you want to work with clinical studies in a world leading dental company? This role will offer you a broad spectrum of tasks in an international environment with many different contact settings. We take great pride in making sure our products are safe and compliant and our clinical studies are a crucial factor in this work.

Come and join our engaged global Clinical Research team!

The Center of Clinical Research at Dentsply Sirona is responsible for the planning and performance of all phases of our clinical studies. This can be sponsored studies on non-approved products as well as on regulatory approved and marketed products.

What are we expecting from you?

In this role you will be responsible for the preparation of the required study documents, including time plans and study agreements. We will expect you to plan and execute all phases of clinical studies as well as studies needed to develop AI-enabled dental software. You will be the go-to person to provide clinical guidance on product design, claims and validation, including study design for reader and standalone studies for AI models. You will work in close collaboration with other departments within Dentsply Sirona, as well as with dental clinics and universities worldwide. This role will offer you great insight to clinical studies in a global context and you will be part of many interesting projects along the way. 

Responsibilities:

• Contribute to the design and execution of clinical studies required for medical devices that are sufficient for ISO 14155, EU MDR and FDA.
• Preparation and submission of clinical study documentation to Independent Ethics Committees/Review Boards and Regulatory Authorities.
• Registration of clinical studies in applicable databases.
• Monitoring of site, data management and follow up on time plan and budget.
• Study data analysis, preparation of clinical study reports and presentation of study data to internal and external parties  
• Serve as the primary dental subject matter expert for internal cross-functional teams developing AI-enabled dental software (e.g. CADe/CADx, AI visualization).
• Provide clinical guidance on product design and validation, including study design for reader and standalone studies for AI models.
• Collaborate with R&D, Quality, Regulatory, and product marketing teams to ensure clinical relevance and safety of AI models and assist in methods to use AI internally for workflow efficiency.
• Stay up to date on AI regulations and AI in dentistry.
• Draft and review key sections of regulatory submissions and technical files such as CERs and study protocols (e.g. multi-reader multi case studies) for AI enabled medical device software.

Qualifications / Background:

• Higher education in natural science.
• Background in dentistry, research and/or clinical studies.
• 3+ years prior experience in clinical affairs, regulatory affairs, and/or clinical research for AI/ML enabled medical device software. (SaMD/SiMD)
• Knowledge of Medical Device regulations related to conduct of human clinical studies (e.g. ISO 14155, EU MDR, FDA, GDPR, Declaration of Helsinki, Good Clinical Practice (GCP) and EU AI Act).
• Experience working with Medical devices is preferable.
• Doctor of Dental Surgery DSD/Doctor of Medical Dentistry (DMD) is a merit.
• Excellent project management and communication skills.
• Fluent English in writing and speaking.
• The ability to travel internationally up to 20 days yearly.

As a person you have a scientific mindset and you are market oriented with a great drive for AI related tasks. You will need to be structured, engaged and solution-oriented with a drive for result. Good collaboration skills are essential as well as strong communication.

The position will be located in Molndal, Sweden, Bensheim, Germany or Charlotte NC, USA. 

Please note that we will review applications continuously, so be sure to send in your CV as soon as possible.

Welcome with your application!

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