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Senior Clinical Project Leader

Apply Now Job ID R-344817 Date posted 08/15/2019

Job Description Summary

Job Description

Reporting to the Senior Manager, Medical Affairs, BD Life Sciences – Preanalytical Systems, this position has the responsibility to ensure compliance of clinical documentation with the European In Vitro Diagnostic Regulation (IVDR). This position is responsible for assessing clinical data requirements of IVDR, developing and implementing plans to remediate gaps, and creating reports to document compliance. The Senior Clinical Project Leader will review and summarize clinical study results, and as needed will design, execute, interpret and summarize the results of new clinical studies. This position will also be responsible for periodic reviews and file updates as needed to ensure compliance is maintained. Additionally, the Senior Clinical Project Leader provides medical, scientific, and technical leadership and perspective to project teams and other functions such as Regulatory and Quality.

THE CLINICAL PROJECT LEADER WILL BE RESPONSIBLE FOR THE FOLLOWING:

  • Ensure in-depth knowledge of the European In Vitro Diagnostic Regulation (IVDR) and specific requirements relating to clinical performance data.
  • Develop project scopes and objectives, involving all relevant stakeholders and ensuring technical feasibility.
  • Establish a project plan and track project performance, specifically to analyze the successful completion of short- and long-term goals.
  • Perform risk management to minimize project risks.
  • Manage changes to the project scope, project schedule and project costs using appropriate verification techniques.
  • Review and interpret clinical study results and the medical/scientific literature on blood collection tubes, and create summaries documenting compliance to IVDR.
  • Design and execute clinical studies for blood collection tubes to generate new data as needed to ensure compliance. Interpret and present results. Prepare or review clinical study reports.
  • Work with project team to ensure compliance with labeling requirements including product labels and Instructions for Use.
  • Provides customer and product knowledge to team.

EDUCATION:

  • BS required, preferably in a health-related field, MS or PhD desirable.
  • LICENSES OR CERTIFICATIONS:
    • MT (ASCP) or equivalent is desirable.

MINIMUM QUALIFICATIONS:

  • 2+ years of combined clinical laboratory experience and/or medical device/IVD experience required
  • 2+ years of clinical trial or clinical research experience ideally medical device is a plus
  • Knowledge of medical device regulations is a plus
  • Strong competency in the areas of clinical study design, statistics, technical writing is a plus
  • Proven working experience in project management is a plus
  • Demonstrated leadership skills
  • Demonstrated capability for strategic and critical thinking, excellent analytical and problem-solving skills
  • Knowledge of scientific methodologies and clinical laboratory science.
  • Excellent interpersonal and communication skills.
  • This position does not provide relocation assistance.

#LI-TECH

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

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All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com