Software Clinical Research Manager

The Clinical Research Manager defines and owns the clinical evidence strategy for new and updated AI and machine learning algorithms within software‑based digital dentistry solutions. The role ensures that clinical intended use, clinical benefit, and performance claims are clinically and scientifically justified, competitively positioned, and acceptable from a regulatory perspective. The Clinical Research Manager steers clinical research, clarifies the clinical performance specifications for an algorithm based on end-user voice-of-customer, clinical data governance, and clinical validation strategy for AI and machine learning algorithms.

Accountabilities

Clinical evidence strategy & competitive landscape:

• Evaluate and clarify clinical intended use, clinical benefit, and accuracy acceptance criteria at project initiation for new and updated AI and machine learning algorithms
• Review scientific literature and existing FDA 510(k) clearances to benchmark claims and validation approaches
• Define clinical evidence roadmaps and required clinical validation studies

Clinical Data Governance & Cross-site Alignment

• Own clinical data governance across research, training, validation, and regulatory use
• Ensure traceability, data integrity, and audit readiness across multiple data collection sites

Collaboration With Research & Innovation

• Collaborate with research teams on new ideas and early feasibility assessments
• Ensure research outputs can be leveraged for downstream validation and regulatory submissions

Clinical Validation & Regulatory Substantiation

• Partner with software validation, quality, and regulatory teams to design clinically meaningful studies
• Show deep understanding of clinical validation study methodologies and statistics.
• Substantiate clinical claims and study designs using literature and regulatory precedent

Leadership & Execution Steering

• Act as escalation point for risks related to data quality, study feasibility, and regulatory alignment
• Define processes to improve efficiency and effectiveness of clinical evaluations.

Qualifications

Job requirements:

• Master or doctoral degree in a relevant field (e.g., Biomedical Sciences, Biomedical Engineering, Data Science, Clinical Research)
• Fluent in English, excellent oral and written communication skills

Skills / Technical Know-how

• Strong understanding of clinical research methodologies, AI validation principles, and regulatory expectations
• Ability to critically assess and synthesize scientific and clinical literature
• Strong cross-functional collaboration and regulatory communication skills
• In depth understanding of the field of Digital Dentistry solutions
• Quality minded, focused on details
• Ability to manage multiple projects and priorities effectively.

Critical Experience

• Experience in clinical evidence generation for medical software or AI-based solutions
• Experience managing or mentoring clinical project or study roles

This role is based in Mechelen with 4x/week onsite requirement.

Operating company:DEXIS

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