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ID de la oferta R-517020 Fecha de publicación 05/05/2025

Job Description Summary

The Clinical Project Coordinator is responsible for delivering high quality and compliant support 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. The Clinical Project Coordinator will be responsible for the day-to-day operational support of assigned clinical studies, management of study supplies and investigational devices and administrative support for the Clinical Affairs team. The Clinical Project Coordinator may also support the review and development of essential clinical study documents.

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 imagination 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. 

Under direct manager supervision (or supervision of other Clinical Affairs personnel), the Clinical Project Coordinator will:

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

  • Ensure quality and compliance for 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. 

  • Prepare and ship clinical study supplies (e.g., study binders, mini protocols, etc.) and investigational products from BD Peripheral Intervention’s headquarters to domestic and international locations for assigned clinical studies.

  • Manage inventory and accountability of clinical study supplies and investigational products.

  • Serve as a Clinical Product Management expert and resource for BD stakeholders, Investigators, and study site personnel.  

  • Support annual Sunshine Reporting activities and track transfers of value for clinical study supplies and investigational products, as appropriate.

  • Support Clinical Project Management and/or Site Management & Monitoring with other administrative tasks (e.g., collection & upload of study documents, Confidentiality Disclosure Agreement requests, Clinical Study Agreement requests, clinical study registration updates, Purchase Order Requests, etc.) as needed, to facilitate the conduct of the study.

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

  • Assist with study and site-level management of the Clinical Trial Management System (CTMS) to ensure that study and site details are current, accurate and complete.

  • Develop, complete and/or manage study-specific Clinical Product Management Plans, Clinical Product Forecasting & Tracking Templates, Clinical Site Product Accountability Logs, Clinical Product Assembly Forms, Clinical Product Inspection Forms, Clinical Product Shipment Request Forms, Clinical Site Product Receipt Confirmations, Clinical Site Product Return Records, Clinical Site Product Destruction Records, Requests for Clinical Supplier Contract Forms, Debarment Checks and other essential clinical study documents, as needed.

  • Review and provide input, as needed, on the development of other essential clinical study documents related to Clinical Project Management, Site Management & Monitoring, Clinical Data Management, Clinical Statistics, Clinical Safety Management, Clinical Product Management and Clinical Supplier Management.

  • Perform general administrative functions for Clinical Affairs team (e.g., new hire onboarding tasks, IT requests, office supply orders, etc.), as needed.

  • Develop and maintain strong relationships with investigational site staff and study teams to support study deliverables. Facilitate communication between clinical sites and BD stakeholders (e.g., Clinical Project Managers, Clinical Research Associates), as needed.  

  • Communicate BD product complaints and other events/issues that inhibit safe and effective use of BD products and negatively impact data integrity and study performance to BD stakeholders in accordance with established clinical study procedures and company policies.  

  • Participate in and/or support study-specific meetings including, but not limited to study team meetings, Clinical Product Management meetings, and vendor meetings.

  • Provide critical thinking and support for issue escalation related to Clinical Product Management. Interact with investigational sites, vendors, and other functional areas for issues, as needed. Proactively identify issues and create mitigation strategies in collaboration with Clinical Project Management and other leadership.

  • Provide support for internal or external audits/inspections and ensure resolution of audit/inspection findings related to Clinical Product Management activities.

  • Support continuous improvement activities/initiatives and sharing of best practices, including development of Clinical Product Management tools and resources.

  • Support processing and entry of clinical site payments/invoices within CTMS, as needed.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. 

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Primary Work Location

USA AZ - Tempe Headquarters

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