KMO Clinical Research Manager; Brea​/Pomona, CA)

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

United States of America Science Job  description

JOB 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.

He/She serves 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.

Candidates must reside within a commutable distance to both Brea, CA and Pomona, CA, as the office location will be relocated from Brea to Pomona in the near future. This is not a hybrid or remote opportunity and requires onsite presence 4 days per week.

PRIMARY

DUTIES & 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

Bachelor’s in Dental Hygiene or, DMD, DDS, or MD degrees.
5+ years of relevant dental experience required (clinical or corporate).Possesses an active dental license in US or Europe.

Experience supporting compliance with FDA, ISO 13485, MDSAP, EU MDR, and GMP.Ability to travel domestically and internationally up to 20%.

PREFERRED QUALIFICATIONS:

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…