Clinical Research Manager

Envista Dentistry•Brea, CA

3d•Onsite

About The Position

The Clinical Research Manager is responsible for managing all US clinical usability studies for Restorative, Endodontics and Preventive, ensuring compliance with regulatory standards for medical devices. This role involves managing vendor relationships with finance and legal, and serving as a core team member with marketing, R&D, and clinical teams in new product development. The position contributes to strategy, design inputs, and successful product launches, and actively participates in the innovation pipeline by identifying opportunities, evaluating concepts, and supporting end-to-end product development. Management of all clinical documentation for new products requiring compliance with MDR regulations, including CER’s, IFU’s, uFMEA’s, PMS plans, and SSCP’s, falls under this role.

Requirements

Doctor of Dental Science (DDS) or similar degree plus 5 years of relevant dental experience required.
Experience supporting compliance with FDA, ISO 13485, MDSAP, EU MDR, and GMP.
Must reside within a commutable distance to Brea, CA or Pomona, CA.
Ability to travel domestically and internationally.
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.

Nice To Haves

Dentist or Hygienist preferred.

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.