Clinical Research Manager

Envista Holdings Corporation; Brea (CA); On-site; USD 126,000 - 153,000; Full time

Job summary

Envista Holdings Corporation is seeking a Clinical Research Manager to lead US clinical usability studies across Restorative, Endodontics and Preventive dental products, ensuring compliance with GCP, ISO 14155, and MDR-related documentation.

You will drive study design, validation, site selection, reports, and cross-functional collaboration with marketing, R&D and clinical teams to support product development and launches, while managing vendors and regulatory partners.

Qualifications

• DDS degree with 5 years of dental experience.
• Residence within commutable distance to Brea, CA or Pomona, CA.
• Experience supporting FDA, ISO 13485, MDSAP, EU MDR, and GMP compliance.
• Ability to travel domestically and internationally.

Responsibilities

• Design, organize, and execute clinical studies for dental products following GCP and ISO 14155.
• Develop and execute design validation protocols for new product development.
• Prepare, review and audit Informed Consent Forms and Case Report Forms.
• Interface with clinicians, investigators and study sites.
• Train personnel for clinical study execution.
• Prepare, distribute, and reconcile devices for clinical evaluation.
• Collaborate with cross functional teams for product development and launches.

Skills

Regulatory compliance

Clinical research

Vendor management

Communication skills

MS Office

Education

DDS or equivalent

5 years dental experience

Tools

FDA compliance

ISO 13485

MDSAP

EU MDR

GMP

Job description

Position 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 14155
• Develop 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 sites.
• Train personnel for clinical study execution.
• Prepare, 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 products.
• Collaborate with cross functional team members, providing input to the DHF for 510k submission and CE tech files.

Job Requirements

Education and Experience

• Doctor of Dental Science (DDS) or similar degree plus 5 years of relevant dental experience required.
• Dentist or Hygienist preferred.
• Experience 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 internationally.

Required Skills and Abilities

• Experience supporting compliance with FDA, ISO 13485, MDSAP, EU MDR, and GMP.
• Strong communication skills, detail-oriented and efficient in time management.
• Basic knowledge of medical device development processes.
• Ability to work in a diverse team, prioritizing and planning own workload.
• Experience using Microsoft Office (Word, Excel, Power Point) to prepare charts, tables, forms, reports, and presentations.
• #LI-CY1 IND123

Target 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

$125,500 - $153,400

Kerr 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: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. 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. Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care. Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com.