Clinical Research Manager

Envista; Brea (CA); On-site; USD 86,100 - 154,900; Full time

Benefits offered by this job

Health & Wellness Benefits

Retirement & Financial Benefits

Life & Disability Insurance

Paid Time Off

Job summary

Envista in California seeks a Clinical Research Manager to lead US clinical usability studies for restorative, endodontics and preventive dental products. You will ensure studies comply with GCP and ISO 14155, manage study sites, create and audit consent and CRFs, and coordinate with marketing, R&D and clinical teams.

Required DDS or equivalent with 5+ years of dental experience, FDA/ISO 13485/MDSAP/GMP knowledge, and ability to travel.

Qualifications

• DDS or equivalent required with 5+ years dental experience
• Knowledge of FDA, ISO 13485, MDSAP, EU MDR and GMP preferred
• Experience designing and managing clinical usability studies and reports
• Ability to travel domestically and internationally

Responsibilities

• Design, organize, and execute clinical studies for dental products in accordance with GCP and ISO 14155
• Develop and execute design validation protocols for new product development
• Prepare and audit Informed Consent Forms and Case Report Forms
• Identify and manage study sites and investigators; interface with clinicians
• Track and report study status using databases and tools
• Create and update technical documentation for MDR/510(k) submissions

Skills

FDA compliance

ISO 13485

MDSAP

GMP

Excellent communication

Microsoft Office

Education

Doctor of Dental Science (DDS) or similar

Tools

Clinical study management tools

Job description

United States of America, California, Brea | United States of America, California, PomonaR5026883United States of AmericaScienceJob descriptionPosition Summary: The Clinical Research Manager is responsible for managing all US clinical usability studies for Restorative, Endodontics and Preventive, making sure that all studies follow regulatory standards for medical devices in addition and managing vendor relationships with finance and legal.Serve as a core team member with marketing, R&D and clinical teams in new product development, and contributing to strategy, design inputs, and successful product launches. Actively contribute to the innovation pipeline by identifying opportunities, evaluating concepts, and supporting end-to-end product development.All clinical documentation for new products that need to comply with MDR regulations including but not limited to CER’s, IFU’s, uFMEA’s, PMS plans and SSCP’s will also be managed at this level.Essential Duties and Responsibilities:Design, organize, and execute clinical studies for new and existing dental products in accordance with Good Clinical Practices and ISO 14155Develop and execute design validation protocols for new product development to ensure that the product meets user needs.Analyze the results and generate reports of design validations and clinical studies.Assist with essential clinical investigation document preparation for IRB approval.Participate in identification, evaluation, and selection of clinical study sites and investigators.Prepare, review and audit Informed Consent Forms and Case Report Forms of study subjects.Interface with clinicians/investigators and clinical research test sitesTrain personnel for clinical study executionPrepare, distribute, and reconcile devices for clinical evaluation.Serve as a core team member with marketing, R&D and clinical teams in new product development, and contributing to strategy, design inputs, and successful product launches.Actively contribute to the innovation pipeline by identifying opportunities, evaluating concepts, and supporting end-to-end product development.Track, review and prepare study-specific information utilizing databases, spreadsheets, and other tools for reporting status updates to the team; maintain study-related databases.Design and execute Human Factor Usability studies.Create and update Risk Management Files (uFMEAs and Risk Tables according to ISO 14971)Support generation of Clinical Evaluation Reports and Post-Market Clinical Follow-Up protocols to assess safety and efficacy of medical devices in compliance with applicable regulations.Participate in the innovation funnel for new products and be part of the core team members for new product development.Write and update Instructions for use for dental productsCollaborate with cross functional team members, providing input to the DHF for 510k submission and CE tech files.Job requirementsEducation and Experience:Doctor of Dental Science (DDS) or similar degree plus 5 years of relevant dental experience required. Dentist or Hygienist preferredExperience supporting compliance with FDA, ISO 13485, MDSAP, EU MDR, and GMP.Must reside within a commutable distance to Brea, CA or Pomona, CA. This is fulltime role and not remote or hybrid.Ability to travel domestically and internationallyRequired Skills and Abilities:Experience supporting compliance with FDA, ISO 13485, MDSAP, EU MDR, and GMP.Strong communication skills, detail-oriented and efficient in time managementBasic knowledge of medical device development processesAbility to work in a diverse team, prioritizing and planning own workloadExperience using Microsoft Office (Word, Excel, Power Point) to prepare charts, tables, forms, reports, and presentations#LI-CY1IND123Target 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.$86,100.00 - $154,900.00 AnnualOperating Company:KerrEnvista 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 moreKerrOperating Company:KerrLocation:United States of America, California, Brea | United States of America, California, PomonaDate Posted:July 19 , 2026Req Number:R5026883BenefitsCaring 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.