Clinical Development Training Manager Akura Medical

• Serve as a crucial member of the clinical study team and 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 to ensure safe and effective use of our devices.
• 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 vendors CROs and internal team members.
• Work with clinical management and product teams to develop internal and external certification programs for procedural proficiency or case coverage roles including precourse training and post training examinations.
• Collaborate with internal and external stakeholders to develop a repository of recruitment/study awareness materials and tools.
• 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 for clinical studies.
• 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 onboard 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.
• Able to identify and resolve obstacles related to clinical study recruitment hurdles etc.
• Minimum of 8 years of relevant clinicbased 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 FDAregulated environment (preferably Class III).
• Experience with a manufacturer of interventional cardiovascular devices and/or interventional imaging modalities preferred.
• Must have excellent communication skills both written and oral.
• If remote from Akuras headquarters must be willing to travel to office on a scheduled basis.
• Other duties as assigned.

• Bachelors degree in related field and 12 years of experience in medical device industry.
• Experience in IDE studies involving class III cardiovascular devices is strongly desired.
• Extensive knowledge of FDA requirements ICH GCP other standards as well as medical terminology.
• Experience interacting with and developing strong relationships with research and procedure support staff at clinical study sites/hospitals.
• Must be willing to travel both domestic & international extensively up to 75.
• Must have excellent verbal and written communication skills.
• High attention to detail accuracy and organizational skills.
• Able to manage multiple project teams with guidance.
• Ability to attain and maintain hospital credentials.
• Selfmotivated and selfdirected; conscientious approach to work assignments; enjoys the challenges of multitasking and working at a fast pace while staying flexible to adapt to market conditions.

Required Experience:

Manager