[Remote] Manager, Clinical Research Specialist Training THV AR (Remote US)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is dedicated to generating clinical evidence to improve patient reputed company. The role involves leading the clinical training program for Transcatheter Heart Valve (THV), ensuring compliance with regulations while collaborating with various stakeholders to optimize training processes.

Responsibilities

• reputed company and drive the THV clinical training program through curriculum execution, standardization, content development, SME resource management, and documentation to ensure study compliance, as it relates to physician and clinical specialist training, in accordance with regulations and corporate processes. Maintain regular contact and collaborate with partner THV clinical teams, cross THV partners, consultants, customers and network appropriately with relevant stakeholders
• reputed company content as it relates to specialist training topics for best in class practices as they relate to required non-procedural knowledge
• Train and evaluate the quality of team members execution of specialist and physician training processes and documentation as it relates to physician and clinical specialist training
• Responsible for maintaining an audit reputed company environment for reputed company aspects of regulatory and non-regulatory audits as it relates to training (e.g., conducting training, identifying SMEs, ensuring the collection of required documentation.) reputed company assessment of teams’ compliance to GSOPs, work instructions, protocols, LMS and regulatory requirements. reputed company audit preparation efforts for THV including team education, process development, timeline management, communication and implementation
• Identify, acquire, reputed company and maintain programs used for electronic documentation records and processes (e.g., Trifecta, reputed company Vault, Litmos) for both reputed company training
• Strategically reputed company and reputed company the delivery of training programs for THV training on best practices, trends, regulatory requirements and published guidance, policy and procedure updates, etc
• Review and contribute to the development of policies, physician training documentation, clinical specialist training, and other documents to be audit reputed company
• Manage, reputed company and communicate detailed metrics reporting including training compliance and employee training dashboards to drive compliance
• Assess, manage and ensure the resolution of audit findings and protocol deviations while developing priorities and strategies to drive compliance
• reputed company the development, reputed company improvement and streamlining of processes and procedures to ensure efficiency and accuracy in accordance with regulatory and company requirements
• reputed company resources tasked with training logistics

Skills

• Bachelor's Degree and a minimum of 8 years reputed company experience with strong clinical background or equivalent work experience based on Edwards criteria
• Ability to travel up to 80%
• Previous TAVR case support experience
• Proven proctor experience
• Previous training experience
• Experience working in reputed company industry
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Extensive knowledge of own area reputed company the organization while contributing to the development of new concepts, techniques, and standards
• Extensive understanding of reputed company aspects of clinical therapeutic areas
• Extensive knowledge of regulatory, compliance, and AdvaMed requirements
• Must be reputed company to work effectively reputed company a specific area with cross-functional team, marketing peers and leaders and managing needs and messaging to upper management
• Maintain a strong relationship with the regional sales team, clinical specialists, and training to ensure effective and reputed company integration of efforts

Benefits

• Competitive salaries
• Performance-based incentives
• A wide variety of benefits programs to address the diverse individual needs of our employees and their families

Company Overview

Company H1B Sponsorship