Principal Clinical Research PM

Position Overview:

Manage assigned departmental projects and tasks in principle areas of responsibility, which are identified below for aortic arch repair technologies, including execution of investigational device exemption (IDE) studies.

Responsibilities:

• Serve as the primary owner of clinical studies, independently overseeing all study activities including stakeholder communication, team leadership, timeline execution, budget management, and issue resolution.
• Act as the main point of contact for assigned studies, leading cross-functional study team meetings and driving accountability across internal and external partners.
• Manage all study vendors, including qualification, onboarding, contract and budget oversight, invoicing, and escalation of operational issues.
• Develop clinical strategy for investigational device exemption (IDE) studies.
• Participate as a core team member, specifically collaborating with Regulatory, Quality, R&D, and Commercial stakeholders.
• Oversee day-to-day site operations at clinical sites to ensure clinical trials are conducted in compliance with protocols, contracts, GCP, and applicable regulatory requirements.
• Lead the development, review, and maintenance of clinical documentation, including protocols, study management plans, informed consent forms, case report forms, SOPs, and study amendments.
• Manage qualification, selection, and operations of study steering and safety committees.
• Plan and support quality initiatives to ensure study readiness for data analyses.
• Support the development of abstracts, manuscripts, and scientific presentations by coordinating with investigators and co-authors.
• Ensure timely preparation and completion of clinical study reports in alignment with regulatory and organizational deadlines.
• Develop and deliver study-related presentations for internal and external audiences.
• Interface with technical representatives, regional managers, and research teams to provide technical training and address clinical or customer-related inquiries.
• Facilitate regulatory submissions, including annual FDA reports and other required regulatory documentation.
• Serve as a reviewer for technical and marketing materials to ensure scientific accuracy and regulatory compliance.
• Collaborate with Quality and Risk Management partners to proactively identify, assess, and mitigate device risks.
• Support site recruitment and selection activities, investigator meetings, and site training initiatives.
• Perform basic statistical analyses to support product lines and clinical decision-making.
• Conduct literature reviews and prepare scientific summaries relevant to product development and clinical strategy.
• Attend national and international surgical and scientific congresses, in person or remotely, as required.
• Perform additional responsibilities, including duties executed at a level above current title, as assigned.

Qualifications:

• Minimum of a Bachelor's degree, preferably a Master's degree (in a related field).
• Minimum 10 years' experience in clinical research or relevant experience, or advanced degree with 8 years' experience.
• Experience with aortic repair technology (i.e. surgical grafts, endovascular devices) is highly desirable.
• Experience working on IDE studies is highly desirable.
• Experience working at a medical device company is highly desirable.
• Demonstrate project management, critical thinking, and communication skills.
• Demonstrated statistical and computer skills (spreadsheet, relational databases, intermediate to advanced statistical analysis).
• Excellent written and oral communication skills.
• Proficient knowledge of medical terminology.
• Willingness to travel.