Clinical Research Manager AI

Clinical Research Manager AI

Join to apply for the Clinical Research Manager AI role at Dentsply Sirona .

Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130‑year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive portfolio of dental and oral health products and other consumable medical devices under a strong portfolio of world‑class brands. Dentsply Sirona’s products provide innovative, high‑quality and effective solutions to advance patient care and deliver better and safer dentistry. The company’s global headquarters is located in Charlotte, North Carolina, USA.

What We Expect From You

In this role you will be responsible for preparing the required study documents, including time plans and study agreements. You will 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.

Responsibilities

• Contribute to the design and execution of clinical studies required for medical devices that are sufficient for ISO 14155, EU MDR and FDA.
• Prepare and submit clinical study documentation to Independent Ethics Committees/Review Boards and Regulatory Authorities.
• Register clinical studies in applicable databases.
• Monitor site, data management and follow up on time plan and budget.
• Analyze study data, prepare clinical study reports and present 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.
• Knowledge of Medical Device regulations related to the conduct of human clinical studies (e.g. ISO 14155, EU MDR, FDA, GDPR, Declaration of Helsinki, Good Clinical Practice (GCP), EU AI Act).
• Experience working with medical devices is preferable.
• Doctor of Dental Surgery (DDS) / Doctor of Medical Dentistry (DMD) is a merit.
• Excellent project management and communication skills.
• Fluent English in writing and speaking.
• Ability to travel internationally up to 20 days yearly.

Position location options: Molndal, Sweden; Bensheim, Germany; Charlotte, NC, USA.

Dentsply Sirona is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status.