Software Clinical Research Manager

Envista Holdings Corporation; Belgique; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Envista Holdings Corporation seeks a Clinical Research Manager to define and own the clinical evidence strategy for AI/ML software in digital dentistry. You will ensure clinical use, benefit, and performance claims are scientifically justified and compliant with regulatory expectations.

You will lead cross-functional teams across research, validation, and regulatory submissions, shaping study designs, governance, and data integrity across sites to support market access and ongoing improvements.

Qualifications

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

Responsabilités

• Define clinical evidence strategy and validation roadmaps for AI/ML software in digital dentistry
• Own clinical data governance across research, training, validation, and regulatory use
• Collaborate with research teams to enable downstream regulatory submissions and validations
• Design clinically meaningful studies and substantiate claims with literature and regulatory precedent
• Lead risk management and improve processes for clinical evaluations and regulatory alignment

Connaissances

Clinical research methodologies

AI validation principles

Regulatory communication

Formation

Master's degree

Doctoral degree

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.

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.

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

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Operating Company:

DEXIS

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee‑based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista’s internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully‑executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.