(Senior) Clinical Project Coordinator

Job Description

We are the people who give possibilities purpose 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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

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 administrative tasks such as collection and upload of study documents, Confidentiality Disclosure Agreement requests, Clinical Study Agreement requests, study registration updates, Purchase Order Requests, and more.
• Maintain the Trial Master File (TMF) and perform study and/or site-level audits to ensure that study files are current, accurate, complete and audit‑ready.
• Manage the Clinical Trial Management System (CTMS) at the study and site level to keep details accurate and complete.
• Create and maintain Clinical Product Management plans, forecasting & tracking templates, product accountability logs, assembly forms, inspection forms, shipment request forms, receipt confirmations, return records, destruction records, supplier contract forms, debarment checks, and other essential clinical study documents.
• Plan, track, and manage 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 an 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, Power Point, One Note, To‑Do, Share Point, etc.).
• Strong interpersonal and communication/presentation (oral and written) skills.
• Strong organizational skills, attention to detail, critical thinking and analytical skills.
• Ability to manage and delegate multiple tasks and prioritize projects.
• Preferred Qualifications
• Knowledge of domestic and international clinical research regulations and guidelines.
• Experience with Good Clinical Practice (GCP) and current industry practices related to the conduct of clinical studies.
• Knowledge of clinical study processes and systems (e TMF, CTMS and CEDMS).
• Prior experience with Veeva Vault preferred.
• 1+ years of experience in a similar role for a sponsor or contract research organization (CRO).
• Location

Primary work location: DEU Karlsruhe. Additional location: CHE Wangs - Straubstrasse.

Equal Opportunity Employer

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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