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Clinical Research Manager

Company: Ortho Development Corporation
Location: Draper
Posted on: June 25, 2022

Job Description:

Ortho Development Corporation is motivated to help people do what they love by restoring mobility. We are passionate about designing and manufacturing the best, clinically-proven, high-performance orthopedic devices in the world. Our product focus is total hip and knee replacement; along with trauma fracture repair, and spine treatment. The Clinical Research Manager will be responsible for overseeing proactive post market surveillance (PMS) assignments for Ortho Development including oversight of developing and maintaining PMS plans (PMSP) and scheduling of PMS reviews (PMSR) according to the review schedule. Primary Responsibilities:

  • Works closely with those developing proactive PMS plans and reviews for Ortho Development. Reviews and delegates PMS project assignments monthly to ensure appropriate volume is assigned. Completes monthly and quarterly KPI reports for management to indicate timeliness of PMSR per procedures.
  • Participates as PMS representative for audits as assigned
  • Elevates, communicates, and drives action and stakeholder management to prevent delays in timely completion of PMSR.
  • Effectively oversees, assists, and advises Proactive PMS SMEs. Develops and maintains the training plan for PMS personnel.
  • Supports coaching and feedback and as appropriate, provides performance input to management.
  • Demonstrates ability to impact and influence others within a team to take action; interacts effectively with various functional groups of the project team; contributes significantly towards the establishment of best practices and serves as a resource and mentor.
  • Is the document owner for Post Market Surveillance Activities; PMS Plans and Review (PMSR) records; responsible for working with Regulatory Affairs to ensure documentation has been reviewed and aligned (when applicable).
  • Ensures Post Market Clinical Follow-up (PMCF) commitments are clearly documented within relative PMSPs, informed within clinical research department.
  • Scheduling and coordination of PMS teams for review of proactive and vigilance activities according to schedule; gathering inputs from cross functional stakeholders, and elevating at-risk findings to senior management.
  • Track execution of PMS plan according to requirements; report to management delayed and at-risk PMS commitments; project management of PMS action items to ensure deadlines met.
  • Completes routine audits of PMCF commitments against PMSP to ensure quality and transparency of commitments is maintained. Training, Skills, Knowledge, and/or Experience: Expected Areas of Competence:
    • Thorough understanding of Proactive Post Market Surveillance Requirements for product registration.
    • Thorough knowledge of Global Medical Device regulations relative to Post Market Surveillance is required.
    • Demonstrated problem-solving strategies developing alternative solutions and contingencies to address issues as they occur.
    • Strong communication skills, both written and verbal; experienced intrapersonal skills and the ability to influence cross functional stakeholders and work in a fast-paced environment prone to change. Strong attention to detail and ability to manage multiple projects and meet deadlines.
    • Proficient with Microsoft Office suite or Microsoft ExcelExperience specific to this position:
      • BS degree required, focus in Sciences or BSN/RN preferred
      • Five years of clinical trial management experience within medical devices.
      • Hospital environment experience
      • Experience in preclinical research
      • Knowledge of FDA regulations and their practical implementation.
      • Ability to work with healthcare professionals, researchers, administrators, and study teams.
      • Experience with statistics or statistical models for clinical studies strongly preferred
      • Demonstrated interpersonal communication skills with the ability to communicate across functional areas
      • Excellent analytical and writing skills
      • Strong project management skills - ability to juggle multiple competing priorities
      • Ability to understand and explain detailed regulations and clinical study procedures
      • Ability to make accurate decisions and use good judgement on complex investigations
      • Ability to comply with complex and changing regulations and prioritize work effectively
      • Must be able to observe and correct inconsistencies (clinical study conduct, trend analysis, etc.)
      • Must be able to interpret medical terminology and review/handle sensitive, confidential material (patient data, product information, etc.)
      • Familiarity with, or ability to learn medical practice, procedures, and terminology, as appropriate for Company's products Additional InformationWe offer competitive compensation and excellent benefits including:
        • Medical, Dental and Vision Insurance
        • Health Reimbursement Account
        • Flexible Spending Account
        • Company paid Life and AD&D Insurance
        • Long Term Disability Insurance
        • Tuition Assistance
        • 10 Paid Holidays
        • 15 days PTO to start
        • Quarterly Bonuses
        • Employee Discounts
        • 401K and 401K match
        • Employee Assistance Program
        • Wellness Coaching and Gym incentives

Keywords: Ortho Development Corporation, Draper , Clinical Research Manager, Healthcare , Draper, Utah

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