Clinical Support Specialist

About the job

Responsible for all activities related to Clinical Field Support within their region of the US Market, including field support for Clinical Sites in our clinical programs (i.e., IDE sites) and clinical case coverage of study and commercial cases.  Works closely with other cross-functional areas such as Sales, Marketing, Clinical Affairs, and R&D. This is a Remote position. The ideal candidate would be located in the Midwest or East Coast areas of the United States.

Essential duties and responsibilities

• Support clinical cases, aiding sites with planning, documenting cases, and sharing best practices
• Serve as an interface between clinical trial sites and the clinical research staff (i.e., case planning and enrollment) where appropriate
• Develop best-in-class clinical knowledge of our products and their usage in various clinical applications
• Support company clinical objectives including the identification of potential study sites and required visits to engage with them
• Support ethics committee/institutional review board and institutional research office submissions, initiation, progress, and conduct of clinical study sites
• Interface with study site staff personnel to answer questions on protocol and study conduct
• Develop collaborative working relationships within the organization in pursuit of the company’s overall business goals
• Support distributors and direct sales efforts to develop the market
• Support business development opportunities that are consistent with the company’s strategy for growth
• Contribute to clinical marketing materials
• Support the management of physician training plans and support materials, providing feedback and supporting the creation of new training materials as required

Education, experience, and skills required

• Excellent communication skills and ability to multi-task in a dynamic start-up environment
• Detailed oriented and organized, excellent project management skills
• 5+ years experience in medical device clinical function, with proven success in achieving clinical objectives.
• Preference for extensive Aortic and/or Peripheral Vascular experience, with embolization experience desired.
• Proven success in achieving clinical objectives in a variety of distribution structures, product segments and customer engagement strategies
• Knowledge of Medical Device Reporting, Vigilance and Safety Reporting in Clinical Investigations including but not limited to 21 CFR 803 and EU MDR

Travel

Approximately 50-75% of work time will be spent traveling.

Physical demands

While performing the duties of this job, the employee is regularly required to stand, walk, and sit for extended periods of time. Occasionally the employee may be required to lift or move at least 25 pounds.  The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Physical demands include air travel, including accommodating time zone adjustments

To  Apply

Interested candidates should submit their resume to careers@shapemem.com with the job title as the subject.
Resumes from recruiters will not be accepted.