KMO Clinical Research Manager

Regulatory Toolkit; Brea (CA); On-site; USD 126,000 - 153,000; Full time

Job summary

Envista’s Kerr division seeks a Clinical Research Manager to lead US clinical usability studies across Restorative, Endodontics and Preventive dental products. You will ensure all studies align with GCP, ISO 14155, and applicable medical device regulations while coordinating with marketing, R&D and clinical teams on strategy and launches.

You will manage regulatory documents (CERs, IFU, uFMEAs, PMS plans, SSCPs), oversee vendors, and travel up to 20%.

Qualifications

• Bachelor’s in Dental Hygiene or, DMD, DDS, or MD degrees.
• 5+ years of relevant dental experience required (clinical or corporate).
• Experience supporting compliance with FDA, ISO 13485, MDSAP, EU MDR, and GMP.
• Ability to travel domestically and internationally up to 20%.

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.

Skills

Clinical research

Regulatory compliance

GCP ISO 14155

Vendor management

Cross-functional

Medical devices

Education

Bachelor’s in Dental Hygiene

DMD/DDS/MD

Tools

Microsoft Office

Job description

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

PREFERRED QUALIFICATIONS

• Possesses an active dental license in US or Europe preferred.
• 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

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.

For Field Sales roles, the salary range listed reflects base pay only and does not include incentive pay opportunities under the applicable sales compensation plan

$125,500 - $153,400

Operating Company

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.