Software Clinical Research Manager

Envista Holdings Corporation; Mechelen; Hybride; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Envista Holdings Corporation is seeking a Clinical Research Manager to lead the clinical evidence strategy for AI-driven digital dentistry solutions. The role ensures clinically justified performance claims and guides regulatory substantiation across multi-site data governance.

You will collaborate with research, regulatory, and software validation teams to design meaningful studies and drive cross-functional alignment. Fluency in English and advanced degrees are required.

Qualifications

• Master's or Doctoral degree required in a relevant field.
• Fluent in English, excellent oral and written communication.

Responsabilités

• Define clinical evidence strategy for AI/ML algorithms in digital dentistry.
• Oversee clinical data governance across research, training, validation, and regulatory use.
• Collaborate with research teams to ensure outputs support regulatory submissions.

Connaissances

Clinical research methods

AI validation principles

Regulatory communication

Cross-functional collaboration

Data governance

Digital dentistry knowledge

Formation

Master's or Doctoral degree in Biomedical Sciences/Engineering/Data Science/Clinical Research

Outils

Regulatory submissions tools

Statistical software

Description du poste

Job Description: 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.

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

Job Requirements

Qualifications

• 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 #LI-PG1

For more information, please visit www.envistaco.com.