Job Description
Responsibilities
- Provide operational support for BDPI clinical studies to enable successful completion of study objectives and deliverables.
- 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.
- Serve as a Clinical Product Management expert and resource for BD stakeholders, Investigators, and study site personnel.
- 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.
- 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.
- Study and site-level management of the Clinical Trial Management System (CTMS) to ensure that study and site details are current, accurate and complete.
- 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.
- Planning, tracking and management of change control requests for the maintenance of product technical documentation in BD Quality Management System (QMS).
Required Skills & Competencies
- Bachelor's Degree (BS/BA) in life sciences or equivalent combination of training and experience (MA/MS preferred)
- 1+ years of experience in clinical research (medical device, pharmaceutical and/or biotechnology), with supply inventory management/shipment, or in a clinical setting
- Proficiency with Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint, etc.)
- Strong interpersonal and communication/presentation (oral and written) skills
- Strong organizational skills, attention to detail, critical thinking and analytical skills
- Able to manage and delegate multiple tasks and prioritize importance of tasks/projects
Preferred Qualifications
- Knowledge of domestic and international clinical research regulations and guidelines, Good Clinical Practice (GCP) and current industry practices related to the conduct of clinical studies
- Knowledge of clinical study processes and systems (eTMF, CTMS and CEDMS). Prior experience with Veeva Vault preferred.
- 1+ years of experience with similar role for a Sponsor or Contract Research Organization (CRO)
Salary Range Information
€53.200,00 - €81.100,00 EUR Annual
Primary Work Location
DEU Karlsruhe
Additional Locations
CHE Wangs - Straubstrasse
Work Shift
Not specified.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.
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