Clinical Research Manager

United States of America, California, Brea | United States of America, California, PomonaR
5026883

United States of America Science 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

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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…