Adona Medical, a Shifamed Portfolio Company, is focused on innovating interventional approaches for heart failure, a complex and progressive condition. Heart failure is a progressive condition that impacts approximately 6.5 million patients in the United States and as many as 26 million patients globally. To learn more about Adona Medical, please visit https://www.adonamed.com/.

ABOUT SHIFAMED

Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

Description

The Principal Field Clinical Engineer is responsible for the management of clinical sites in support of clinical trials in the United States and other countries as required. This individual is responsible for interfacing with, supporting and overseeing clinical procedures at clinical sites. Responsibilities include and are not limited to site start-up, device training, site and study logistics and technical procedure support. Additional activities include site interfacing to ensure timely patient scheduling for key trial follow-up endpoints, interfacing with external CROs on an as-needed basis, providing user feedback to company engineering teams and supporting RA/QA objectives related to field operations.

Responsibilities, Skills & Hands-On Experience

• Serve as a crucial member of the clinical study team and will be accountable for onboarding sites and physician partners to clinical studies.
• Demonstrate understanding of the therapeutic area of interest and the study protocol assigned.
• Support Investigator/site training, Site device installation and ongoing technical support.
• Lead proctoring of index and follow up procedures ensuring the investigators adhere to the study protocol.
• Develop training materials to enable training of physicians and participating sites.
• Collect, Document, analyze, and communicate user feedback (VOC) and other field data to inform R&D activities.
• Participate in Site initiation visits and training of site staff.
• Prepare participating clinical sites for potential inspections.
• Support functions relevant to clinical trials such as recording of device deficiencies and adverse event reporting.
• Identify user needs to support marketing objectives and/or new initiatives.
• Collaborate with clinical management to identify, on-board, and manage clinical investigators /KOL management.
• Obtain and analyze clinical data and generate reports for regulatory filings. In addition to standard clinical data this would include procedure workflow time data and other engineering data that might be used to drive procedure and/or device optimization.
• Maintain and work in compliance with company SOPs. Ensure that procedures are sufficient and adequate for conducting regulated clinical trials. Develop and implement procedures and work instructions, as necessary, to ensure conformance with Good Clinical Practices.
• Able to learn new clinical therapy areas quickly and work with physician key opinion leaders.
• Minimum of 8 years of relevant, clinic-based, cath lab work experience in clinical support roles for commercial products and precommercial studies for high risk, class III cardiovascular devices
• Minimum 8 years of experience in an FDA-regulated environment (preferably Class III).
• Experience with a manufacturer of interventional cardiovascular devices preferred.
• Must have excellent communication skills, both written and oral
• Must be willing to travel nationally and internationally – up to 80% - to set up, support and monitor clinical trial sites.

Education & Work Experience

• Bachelor’s degree in related field and 12 years of experience in medical device industry.
• Experience in IDE studies involving class 3 cardiovascular devices is strongly desired.
• Extensive knowledge of FDA requirements, ICH GCP, other standards as well as medical terminology.
• Experience interacting with research staff at clinical study sites/hospitals.
• Must be willing to travel, both domestic & international, extensively up to 70%.
• Self-motivated and self-directed; conscientious approach to work assignments; enjoys the challenges of multitasking and working at a fast pace while staying flexible to adapt to market conditions.

Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider current market rate, and title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $165,000 to $190,000 equity benefits.

NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.