• 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, tofacilitatethe 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,completeand audit-ready.

• Assistwith study and site-level management of the Clinical Trial Management System (CTMS) to ensure that study and site details are current,accurateand 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 forClinicalAffairs team (e.g., new hire onboarding tasks, IT requests, office supply orders, etc.), as needed.

• Develop andmaintainstrong 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 stakeholdersin accordance withestablished 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 forissueescalation related to Clinical Product Management. Interact with investigational sites, vendors, and other functional areas for issues, as needed. Proactivelyidentifyissues 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.

Physical Demands:

While performing the duties of this job, the employeeis regularly required tostand, walk, sit, use sight, and use hands to manipulate,handleor feel objects, tools, controls, and office equipment. The employeefrequentlyis required toverbally communicate with other associates. The employeeis occasionally required toreach with hands and arms and stoop, kneel or crouch.  

Work Environment:

While performing the duties of this job, the employee may be in an open cubicle environment. Candidatemust be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.