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

Note: The job is a remote job and is open to candidates in USA. Edwards Lifesciences is dedicated to generating clinical evidence to improve patient outcomes. 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

• Lead 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
• Develop 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 ready environment for all aspects of regulatory and non-regulatory audits as it relates to training (e.g., conducting training, identifying SMEs, ensuring the collection of required documentation.) Lead assessment of teams’ compliance to GSOPs, work instructions, protocols, LMS and regulatory requirements. Lead audit preparation efforts for THV including team education, process development, timeline management, communication and implementation
• Identify, acquire, develop and maintain programs used for electronic documentation records and processes (e.g., Trifecta, Veeva Vault, Litmos) for both internal and external training
• Strategically develop and lead 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 ready
• Manage, leverage 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
• Lead the development, continuous improvement and streamlining of processes and procedures to ensure efficiency and accuracy in accordance with regulatory and company requirements
• Lead resources tasked with training logistics

Skills

• Bachelor's Degree and a minimum of 8 years related 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 healthcare 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 within the organization while contributing to the development of new concepts, techniques, and standards
• Extensive understanding of related aspects of clinical therapeutic areas
• Extensive knowledge of regulatory, compliance, and AdvaMed requirements
• Must be able to work effectively within 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 optimal 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