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    Clinical Research Manager, Dental Orthodontic Aligner Solutions - Charlotte, United States - Dentsply Sirona

    Dentsply Sirona
    Dentsply Sirona Charlotte, United States

    2 weeks ago

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    Description

    Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona's products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona's global headquarters is located in Charlotte, North Carolina. The company's shares are listed in the United States on NASDAQ under the symbol XRAY.

    Bringing out the best in people

    As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we're looking for the best to join us.

    Working at Dentsply Sirona you are able to:

    Develop faster - with our commitment to the best professional development.

    Perform better - as part of a high-performance, empowering culture.

    Shape an industry - with a market leader that continues to drive innovation.

    Make a difference -by helping improve oral health worldwide.

    The Clinical Research Manager, Orthodontic Aligner Solutions (OAS) is responsible for the planning and execution (preparation of required formal study documents, time plans and study agreements, study monitoring, reporting) of all phases of clinical studies with main focus on studies for OAS, but also managing DS study sites in the US and Canada. This position is also responsible for supporting New Product Development and product maintenance activities in OAS by providing clinical input.

    Must live within a 1-hour commute of our Charlotte Innovation Center, located in Charlotte, NC, to be considered.

    Key Responsibilities:

    The role is interactive and involves the following responsibilities and activities:

    Clinical Studies (Clinical Research):

    • Planning and execution of clinical studies according to applicable regulations with focus on OAS and DS study sites in US and Canada
    • Preparation of study documents such as study protocol and study agreement
    • Preparation and submission of clinical investigation documentation to Independent Ethics Committees/Review Boards and Regulatory Authorities
    • Registration of clinical studies in applicable databases
    • Monitoring - up to 20 travel days are expected
    • Data management and follow up on time plan and budget
    • Study data analysis, preparation of clinical investigation reports and presentation of study data to internal and external parties
    Clinical & Scientific Support OAS:
    • Provides clinical input for the planning of clinical studies, in-vitro studies, IIS (Investigator Initiated Studies), and PMCF for OAS
    • Supports the Center of Excellence for Clinical/Regulatory Compliance with clinical expertise regarding OAS
    • Contributes to clinical design input, participates in DPR (Detailed Product Requirement) activities, V&V (Validation and Verification) planning, and DVP (Design Validation Plan) development.
    • Provides clinical input to QA regarding product complaints and assists in writing HHE (Health Hazard Evaluations) as applicable
    • Supports internal and external Professional Product Evaluations in collaboration with the Clinical Affairs team
    • Provides clinical support for the review and approval of IFU (Instructions for Use)
    • Engages with the OAS Marketing team to provide and/or assist with scientific and clinical support such as scientific clinical communication, scientific manuals, literature reviews, and white papers
    • Other, non-specified, projects and tasks that may arise and fall within the responsibility of clinical research
    Education:
    • Bachelor's Degree is required
    • MS degree is preferred
    Certifications/Licensing:
    • Certified Registered Dentist is a plus
    Years and Type of Experience:
    • Minimum of 5 years related clinical experience in medical devices, dental and/or orthodontic field
    • Dental and/or Orthodontic experience is a plus
    • Experience with product development in the medical device industry is a plus
    • Knowledge of Medical Device regulations related to conduct of human clinical studies (e.g. FDA, ISO 14155, MDR, GDPR, Declaration of Helsinki and Good Clinical Practice (GCP))
    Key Required Skills, Knowledge, and Capabilities:
    • Knowledge of clinical dentistry
    • Excellent written and verbal communication skills
    • Must live within a 1-hour commute of our Charlotte Innovation Center, located in Charlotte, NC, to be considered.
    Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona.

    If you need assistance with completing the online application due to a disability, please send an accommodation request to Please be sure to include "Accommodation Request" in the subject.

    For California Residents:

    We may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes).

    The above categories of personal information are collected for the following business purposes: performing recruitment and hiring services; processing interactions and transactions (e.g., to comply with federal and state laws requiring us to maintain certain records, managing the workforce); and security (e.g., detecting security incidents, protecting against fraudulent or illegal activity).

    For additional details and questions, contact us at
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