Hybrid Clinical Project Manager

at BD

• Job title: Clinical Project Manager
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: PLN 232,000 - PLN 353,800 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Google Cloud Platform, Vault
• Location requirements: Hybrid, Warsaw, Poland

About the role

• Clinical Project Manager at BD managing pre-/post-market studies in vascular and oncology fields. Ensuring completion of deliverables on time and within budget with strong regulatory compliance.

Responsibilities

• Planning and execution of pre-/post-market clinical studies (vascular, oncology); ensure deliverables are completed on time and within budget.
• Provide regular reporting of metrics to Clinical Affairs leadership.
• Develop Clinical Investigation Plans (CIPs), Informed Consent Forms (ICFs), Study Management Plans, Case Report Forms (CRFs), and support the creation and maintenance of full clinical study documentation.
• Review and provide input on the development of other essential clinical study documents related to clinical data management, clinical statistics, site management & monitoring, clinical safety management, clinical product management, and clinical supplier management.
• Compile regulatory dossiers and submit clinical studies to Ethics Committees (ECs) and Competent Authorities (CAs) in the European Union, the United Kingdom, and Switzerland.
• Communicate with ECs and CAs on all study-related questions and obtain approvals required to conduct the study.
• Develop and manage clinical study budgets and conduct monthly financial reviews, including invoice review/approval and accruals for assigned clinical project(s).
• Ensure timely study reporting to Ethics Committees and Competent Authorities.
• Perform study- and/or site-level audits of the Trial Master File (TMF) to ensure that study files are current, accurate, complete, and audit-ready.
• Oversee study- and site-level management of the Clinical Trial Management System (CTMS) to ensure that study and site details are current, accurate, and complete.
• Interact with and/or oversee interactions with investigational sites, vendors, key opinion leaders (KOLs), and consultants.
• Manage external contractors/suppliers.
• Coach and ensure successful and effective relationships between study teams and investigational site personnel.
• Provide support for internal or external audits/inspections and ensure resolution of audit/inspection findings related to assigned clinical projects.
• Conduct site management & monitoring, clinical product management, and clinical field support activities/visits, as needed.
• Conduct, attend, or support training and observational activities, as needed, for study team members.

Requirements

• Bachelor’s Degree (BS/BA) in life sciences or equivalent combination of training and experience (MA/MS preferred)
• 5+ years of experience in clinical research (medical device, pharmaceutical and/or biotechnology)
• 3+ years of experience in managing clinical studies
• Strong working knowledge of clinical research regulations and guidelines, Good Clinical Practice (GCP) and current industry practices related to the conduct of clinical studies
• Strong interpersonal and communication (oral and written) skills; English and at least one further EU language (German or French is a plus)
• Experience with Veeva Vault Clinical Suite (CTMS, CDMS and eTMF)
• Experience with clinical studies related to peripheral vascular diseases, end-stage kidney disease, and/or oncology, as well as experience with medical device studies (strongly preferred)
• Ability to travel in Europe up to 25% (or more during peak times)

Benefits

• Health insurance
• 401(k) matching
• Professional development opportunities
• Paid time off
• Flexible working hours