Job Description Summary

Job Description

We are the makers of possible 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the creativity and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Position Summary:  The Clinical Safety Coordinator is responsible for delivering high quality and compliant day-to-day operational support for the Clinical Safety team for clinical studies (e.g., EFS/FIH, IDE, Post-Market) sponsored by the BD Peripheral Intervention business unit to ensure they meet the highest standards for scientific quality, integrity and ethics and are conducted in accordance with BD global clinical procedures, study protocols, GCP and all applicable regulations.  

Key Job Responsibilities:  

• Provide operational support for Clinical Safety management activities for BDPI clinical studies to enable successful completion of study objectives and deliverables.   

• Ensure quality and compliance for safety-related activities performed for assigned clinical studies ensuring the highest standards for scientific quality, integrity and ethics are met and that these are conducted in accordance with BD global clinical procedures, study protocols, GCP and all applicable regulations.  

• Develop and maintain strong relationships with investigational site staff, HCP consultants (e.g., Medical Monitors, CEC/DMC members), and cross-functional study teams to support Clinical Safety deliverables.

• Facilitate communication between clinical sites and BD stakeholders (e.g., PMs, CRAs), as needed.   

• Support Trial Master File (TMF) maintenance for Clinical Safety documentation and perform study and/or site-level audits to ensure that study files are current, accurate, complete and audit-ready. 

• Support the Clinical Safety team with other administrative tasks (e.g., collection of study documents, Confidentiality Disclosure Agreement requests, HCP Consulting Agreements, etc.) as needed, to facilitate the conduct of the study. 

• Support the management of study-specific tracking reports for Clinical Safety, as needed, to ensure Clinical Safety reporting is completed compliantly and that other Clinical Safety deliverables are completed within study-specific timelines and budgets for assigned clinical studies. Provide regular Clinical Safety status updates to relevant BD and study partners. 

• Support the development and completion of study-specific Clinical Safety Plans, Medical Monitor Approval Forms, Clinical Events Committee (CEC) Charters, Data Monitoring Committee (DMC) Charters, and other safety-related study documents, as needed. 

• Support the reporting and escalation of BD product complaints and other events/issues that inhibit safe and effective use of BD products and negatively impact data collection.   

• Support safety-related intera