Clinical Project Manager

Responsibilities

• Plan and execute pre- and post-market clinical studies for vascular and oncology medical devices, ensuring deliverables are on time and within budget
• Develop essential clinical documentation including Clinical Investigation Plans (CIPs), Informed Consent Forms (ICFs), and Case Report Forms (CRFs)
• Compile regulatory dossiers and manage submissions to Ethics Committees (ECs) and Competent Authorities (CAs) in the EU, UK, and Switzerland
• Manage clinical study budgets, including monthly financial reviews, invoice approvals, and accruals
• Perform study and site-level audits of the Trial Master File (TMF) to ensure audit readiness
• Oversee the Clinical Trial Management System (CTMS) to maintain accurate study and site details
• Manage relationships with investigational sites, vendors, key opinion leaders (KOLs), and external contractors
• Provide support for internal or external audits and inspections to resolve any findings

Requirements

• Bachelor’s Degree in life sciences or equivalent combination of training and experience
• 5+ years of experience in clinical research (medical device, pharmaceutical, or biotechnology)
• 3+ years of experience specifically managing clinical studies
• Strong working knowledge of Good Clinical Practice (GCP) and clinical research regulations
• Proficiency with Veeva Vault Clinical Suite (CTMS, CDMS, and eTMF)
• Fluency in English; proficiency in German or French is a plus
• Ability to travel within Europe up to 25% or more during peak periods

About the Company

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our purpose, and we work to find transformative solutions that turn dreams into possibilities across design, engineering, manufacturing, and marketing.