play a critical role in assigned Business Unit clinical study execution including leading the internal specialist training program and maintain an audit ready environment by ensuring compliance with all physician and training procedures, maintain drive high levels of accuracy and compliance
Lead and drive the Business Unit 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 BU clinical teams, cross BU 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 BU 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 BU 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.

Requirements

Bachelor's Degree or Equivalent
8 years experience of work experience with strong clinical background or equivalent work experience based on Edwards criteria
Up to 50% travel nationwide required
Completion of an accredited program with a Registered Nursing (RN) license, Registered Respiratory Therapist (RRT) certification, Registered Diagnostic Cardiac Sonographer (RDCS)
Proven successful organizational and project management skills
Proven expertise in Microsoft Office Suite
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
Strict attention to detail
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Ability to manage competing priorities in a fast paced environment
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.
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Benefits

competitive salaries
performance-based incentives
wide variety of benefits programs to address diverse individual needs

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical study executioncurriculum executioncontent developmenttraining program developmentaudit preparationregulatory compliancedocumentation managementmetrics reportingprocess improvementproject management

Soft Skills

organizational skillscommunication skillsinterpersonal skillsnegotiation skillsrelationship managementattention to detailability to manage competing prioritiesteam collaborationproblem-solvingleadership

Certifications

Bachelor's DegreeRegistered Nursing (RN) licenseRegistered Respiratory Therapist (RRT) certificationRegistered Diagnostic Cardiac Sonographer (RDCS)