BD (Becton, Dickinson and Company) Senior Project Coordinator I in Research Triangle Park, North Carolina
Job Description SummaryThis position will function within the Operations and Planning Unit of Corporate Preclinical Development and Toxicology (CPDT) and will support the conduct of nonclinical laboratory investigations of medical devices and materials in accordance with GLP and ISO 17025 regulations and the BD CPDT Quality System.
This position provides operational support for preclinical testing projects to facilitate CPDT requests, department workflows, test sample management, monitor deadlines and deliverables, coordinate testing activities, produce technical reports, provide client support, manage subcontracted studies to completion, and perform final review of project folders.
(Planning) Work with worldwide Sponsors to understand a project’s requirements if testing is deemed necessary. Determine and communicate deliverables and deadlines to business unit core project teams to ensure accurate expectation setting/planning. Reach out for any required documentation, define sample types and sample size requirements, and give expected completion dates for any deliverables. In cases of expedited requests, work with the necessary group managers to agree on accelerated timeline/strategy.
(Initiation) Receive and record shipments, create inventory documentation (Master Inventory logs, labels, etc). Manage test sample inventory by documenting chain of custody and aliquot to appropriate personnel as needed. Generate and/or approve Statement of Work contracts. Work with toxicologists and group managers to ensure test plans are developed to meet project goals. Create, organize, and maintain hard copy testing project files and electronic database. Generate quotes for projects.
(Study Involvement) Create Surface Area Records to be used in study conduct.
(Monitoring) Monitor progress of multiple projects that are upcoming and ongoing. Provide customers, Sponsors, and internal management with progress reports/status updates. Promptly identify issues or delays and work with affected personnel to resolve issues and communicate any changes in strategy or timelines.
(Closure) Promptly communicate all applicable reports and deliverables to the customer, Sponsor, and appropriate internal personnel. Conduct final review of project folders to ensure all deliverables have been communicated and project goals have been met.
(Subcontract Studies) Initiate and manage all subcontract studies to completion. Complete test request forms, send samples, resolve any questions from the CRO, and approve invoices for payment.
Serve as the owner of assigned equipment per CPDT SOP requirements.
Perform other duties as assigned.
Minimum of a Bachelor’s Degree in physical science such as biology, chemistry, material sciences, toxicology, or related field.
A minimum of 1+ years relevant experience in a CRO, project coordination and/or project management.
- Working knowledge of computers (Word, Excel, Access, PowerPoint, SharePoint). Understanding of GLP or GMP quality system, ISO 10993, ISO 17025, and other international medical device standards.
- Must be comfortable in a multi-tasking deadline driven environment. Concise communication skills are needed, as well as the ability to edit communications to the appropriate level based on the recipient. Must be focused on customer satisfaction. Must be well-organized with attention to detail. Must be able to self-prioritize work with good time management skills to achieve cost-effective and efficient completion of tasks. Must be proficient with MS Word, Outlook, and Access and have at least intermediate skills in MS Excel. Other preferred software: Sharepoint, LIMS systems, and DocuSign.
Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction 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.
Primary Work LocationUSA NC - Research Triangle Park
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.