Director, Clinical Affairs
Our Company
Gentuity is an exciting and highly innovative medical technology firm, active in the research and development, clinical translation, and commercialization of vascular imaging devices. This opportunity provides the candidates the unique chance to work on innovative medical products, with the potential to significantly change the practice of medicine in the care of patients suffering from a wide range of highly debilitating vascular diseases.
SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:
• Developing and executing clinical studies to the study timelines
• Managing study related activities from site selection through study closure
• Perform site related activities, such as initiation, monitoring, and closure visits
• Able to successfully collaborate with internal stakeholders
• Responsible for IRB submissions and oversight
• Responsible for CRO contract and budget negotiations
• Lead clinical protocol and informed consent development
• Directs the selection of investigational sites
• Establishing data collection methods and activities
• Ability to train clinical study staff on protocol and clinical trial regulatory requirements
• Ability to manage in-house data files
• Reviews, approves and supervises all aspects of post-marketing clinical study programs
• Sponsor liaison with investigational site staff
• Create the investigator and sponsor study documentation files
• Maintain the sponsor study documentation files
• Execute clinical trial agreements and budget planning and management
• Performs miscellaneous clinical research related duties as assigned
• Assist with clinical evaluation report writing and PMS related clinical activities for EU
• Assist with clinical study report writing
• Assist with Investigational Device Exemption preparation
• Management of clinical third-party vendors
• Assist in research case support at clinical sites
• Up to 30% travel.
EXPERIENCE/SKILL REQUIREMENTS:
Minimum of 7 years of clinical study management and able to lead and execute clinical studies to plan. A proven working knowledge in the following areas:
• Experience with intravascular catheters and/or products, highly preferred
• Medical device study experience in the field of cardiology, preferably interventional cardiology
• Selection and management of EDC systems
• US and EU clinical study experience, Japan experience a plus
• IDE and/or studies connected OUS
• GCPs, ICH guidelines, 21 CFR 11, 50, 54, 56, 812 and ISO 14155-1
• Able to effectively manage workload and deliverables independently
• Excellent verbal and written communication skills
• Thrives in a small size company and cross-functional team driven environment
• Possess strong organizational skills
• Responsible team player that takes initiative and has a solution driven mindset
• Working knowledge of Microsoft office applications including Word, Excel, PowerPoint, Outlook, and MS Project.
EDUCATIONAL REQUIREMENTS:
BS in Life Sciences, Healthcare, Biomedical Engineering, or related field.
CRA certification, preferred.