Software Clinical Research Manager

Envista; Vlaams-Brabant; Sur place; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Health & Wellbeing

Retirement & Financial Benefits

Life & Disability Insurance

Paid Time Off

Learning & Career Development

Résumé du poste

Envista Belgium seeks a Clinical Research Manager to define the clinical evidence strategy for AI and machine learning in digital dentistry. You will steer clinical research, govern data across sites, and align validation with regulatory standards.

Strong literature synthesis and cross-functional collaboration are essential to support regulatory submissions. You will partner with software validation and regulatory teams, ensuring clinical claims are scientifically justified and meet regulatory

Qualifications

• Strong understanding of clinical research methodologies, AI validation principles, and regulatory expectations.
• Ability to critically assess and synthesize scientific and clinical literature.
• In-depth understanding of Digital Dentistry solutions and regulatory precedent.
• Cross-functional collaboration and clear regulatory communication across teams.

Responsabilités

• Define and own the clinical evidence strategy for AI/ML in digital dentistry.
• Govern data across research, training, validation, and regulatory use with audit readiness.
• Collaborate with research teams and ensure outputs support regulatory submissions.
• Design clinically meaningful studies and substantiate clinical claims with literature.

Connaissances

Clinical research methodologies

AI validation principles

Regulatory communication

Literature synthesis

Formation

Master or doctoral degree in a relevant field

Description du poste

Belgium, Flemish Brabant, MechelenR5027038BelgiumProject/Program ManagementJob descriptionThe 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 studiesClinical 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 sitesCollaboration 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 submissionsClinical 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 precedentLeadership & 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 requirementsQualifications: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 skillsSkills / technical know-howStrong understanding of clinical research methodologies, AI validation principles, and regulatory expectationsAbility to critically assess and synthesize scientific and clinical literatureStrong cross-functional collaboration and regulatory communication skillsIn depth understanding of the field of Digital Dentistry solutionsQuality minded, focused on detailsAbility to manage multiple projects and priorities effectively.Critical experience:Experience in clinical evidence generation for medical software or AI-based solutionsExperience managing or mentoring clinical project or study roles#LI-PG1Target Market Salary Range:Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.-Operating Company:DEXISEnvista 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.Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdfRead moreDEXISOperating Company:DEXISLocation:Belgium, Flemish Brabant, MechelenDate Posted:August 23 , 2026Req Number:R5027038BenefitsCaring for our employees and their familiesHealth & WellbeingWe offer comprehensive programs designed to support the health and wellbeing of our employees and their families. From medical coverage to wellness resources, we prioritize helping our people thrive both physically and mentally.Retirement & Financial BenefitsWe are committed to supporting our employees’ financial wellbeing—today and in the future. Our competitive compensation and retirement or savings programs are designed to help employees build financial confidence at every stage of their careers.Life & Disability InsuranceWe provide benefits that help protect employees and their loved ones when it matters most. Depending on location, our life and disability programs offer valuable financial security and added peace of mind during unexpected life events.Paid Time OffWe know that time away from work is essential for rest, balance, and personal priorities. Our paid time off, holidays, and leave programs are designed to give employees the flexibility to recharge and take care of what matters most.Learning & Career DevelopmentWe believe in investing in our people. Through learning opportunities, development programs, and career growth pathways, we empower employees to build meaningful careers and continue growing with us.Our hiring processAt Envista, we’re committed to helping you feel confident and prepared every step of the way. Our interview guide will walk you through what to expect, how to showcase your strengths, and how you can make an impact by helping us champion dental professionals and improve lives.1. Application ReviewAfter you apply, our team will review your experience and qualifications. If your background aligns with the role, a recruiter will reach out to discuss the opportunity and next steps.2. InterviewsYou’ll meet with members of the hiring team to learn more about the role and share your experience. Depending on the position, this may include multiple conversations focused on your skills, experience, and how you can make an impact.3. Offer DecisionIf selected, you’ll receive an offer outlining compensation, benefits, and other details. Our team will guide you through the process and answer any questions to help you make an informed decision.4. OnboardingOnce you join, we’ll support your transition with onboarding resources and guidance to help you get started and feel connected from day one.