Sr. Clinical Support Specialist - Aortic
Terumo Medical CorporationAbout the role
At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy.
The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida.
Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally. Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals. Working for the company, each associate’s role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide.
At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.
Join us and help shape wherever we go next!
Advancing healthcare with heart
Job Summary
The Senior Clinical Support Specialist - Aortic (Sr. CSS) is instrumental in clinical trial execution, bringing extensive expertise in managing clinical trial site relationships from selection through enrollment on a national and global scale. As a seasoned subject matter expert (SME) in the aortic disease state, the Sr. CSS manages site recruitment and qualification, drives patient recruitment and enrollment strategies at the study level, and ensures high standards in protocol adherence, patient safety, and procedural outcomes during case support.
The Sr. CSS - Aortic assumes a mentorship role within the Clinical Support team, providing strategic direction, and expertise in the planning and execution of clinical research programs.
Job Details/Responsibilities
- Manages study activities at the site, including oversight of site selection, Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), expert-level procedural support including pre-case planning, protocol eligibility, query resolution, and ensures the accuracy and timely execution of core-lab imaging requirements, including uploads.
- Develops and maintains study specific Clinical Support Plans (CSP), Investigational Product Management Plan (IPMP), Clinical Training Plan, and others study plans as assigned and secures compliance to plans across team members.
- Trusted clinical advisor to aortic Investigators and research staff, ensuring strict adherence to protocol, including eligibility during case support, regulatory compliance, and the efficient conduct of study operations, as well as providing technical assistance with Terumo products, reporting device complaints when appropriate, within company guidelines.
- Provides input on key study documents, including protocols, study plans, Investigational Brochures, and Information for Use to drive successful outcomes as a clinical SME for the aortic disease state.
- Develops and manages tools to track and analyze trends at sites and across the study including site-specific recruitment, patient screening and enrollment metrics, investigational device use/errors, and identifies additional study specific trends that may require evaluation and/or mitigation.
- Mentors and Facilitates collaboration with cross-functional teams to ensure adherence to study protocols, regulatory guidelines, and industry standards throughout the duration of clinical trials, including GCP, ICH, and FDA guidelines.
- Maintains oversight of strict medical device transaction accountability at the site and study level to ensure accurate fulfillment and consumption of investigational products. This includes ownership and mentoring of team members.
Knowledge, Skills and Abilities (KSA)
- Exceptional clinical knowledge base in anatomy, physiology, aortic, neurovascular, and cardiology/interventional procedures and terminology.
- Comprehensive understanding of angiographic imaging and aortic case progression.
- Ability to review CT imaging for educational and procedural support purposes in aortic disease–focused clinical studies.
- Ability to develop strong relationships in a highly trusted role with investigator base including study coord
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