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(Senior) Clinical Project Coordinator(m/w/x)
Operational support for clinical studies, including supply preparation and shipment. Clinical Product Management expertise and TMF maintenance required. Global medical technology company, 1+ years clinical research experience needed.
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Anforderungen
- Bachelor’s Degree (BS/BA) in life sciences or equivalent training/experience (MA/MS preferred)
- 1+ years clinical research experience (medical device, pharmaceutical, biotechnology) with supply inventory management/shipment, or clinical setting
- Proficiency with Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint)
- Strong interpersonal and communication/presentation skills (oral and written)
- Strong organizational, attention to detail, critical thinking, and analytical skills
- Ability to manage and delegate multiple tasks and prioritize importance
- Knowledge of clinical research regulations, guidelines, GCP, and industry practices
- Knowledge of clinical study processes and systems (eTMF, CTMS, CEDMS); Veeva Vault experience preferred
- 1+ years similar role experience for Sponsor or CRO
Aufgaben
- Provide operational support for clinical studies
- Prepare and ship clinical study supplies
- Serve as a Clinical Product Management expert
- Support Clinical Project Management and Site Management
- Maintain Trial Master File (TMF)
- Perform study and site-level audits
- Manage Clinical Trial Management System (CTMS)
- Create and maintain clinical product management plans
- Forecast and track clinical product needs
- Maintain clinical site product accountability logs
- Assemble and inspect clinical products
- Request and confirm clinical product shipments
- Manage clinical site product returns and destruction
- Handle clinical supplier contract forms
- Conduct debarment checks
- Plan and track change control requests
- Maintain product technical documentation in BD QMS
Berufserfahrung
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Zur Originalanzeige bei Becton, Dickinson, and CompanyÜber das Unternehmen
BD is a global medical technology company advancing the world of health by designing, engineering, manufacturing, and marketing MedTech products.
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