Clinical Project Manager

Pracovní nabídka

Main responsibilities will include:

• 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.

About You

• 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)