Clinical Project Leader
Job Description Summary
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 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 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.
- BS required, preferably in a health-related field, MS or PhD desirable.
- LICENSES OR CERTIFICATIONS:
- MT (ASCP) or equivalent is desirable.
- 2+ years of combined clinical laboratory experience and/or medical device/IVD experiencerequired
- 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.
Primary Work LocationUSA NJ - Franklin Lakes
Recommendto a friend
"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
Anonymous, Franklin Lakes, NJ