Bachelor's degree required; Master's preferred in a related field.
10 years of clinical research experience or 8 years with an advanced degree.
Desirable experience with aortic repair technologies (surgical grafts, endovascular devices).
Experience with investigational device exemption (IDE) studies is a plus.
Background in a medical device company is highly desirable.
Strong project management, critical thinking, and communication skills.
Proficient in statistical analysis and computer skills, including spreadsheets and databases.
Responsibilities
Oversee all activities of clinical studies, ensuring effective stakeholder communication and team leadership.
Lead cross-functional meetings and drive accountability among internal and external partners.
Manage vendor relationships, including onboarding, contracts, and budget oversight.
Develop clinical strategies for IDE studies and ensure compliance with protocols and regulations.
Collaborate with Regulatory, Quality, R&D, and Commercial teams as a core member of the project team.
Ensure clinical trials are conducted in compliance with GCP and regulatory requirements at clinical sites.
Prepare and maintain clinical documentation, including protocols and study management plans.
Benefits
Opportunity to lead innovative clinical studies in a cutting-edge field.
Collaborative work environment with cross-functional teams.
Exposure to national and international surgical and scientific congresses.
Professional development through participation in quality initiatives and scientific presentations.
Potential for career advancement in a growing medical device company.
Full Job Description
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).
