Software Clinical Research Manager
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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.
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