The Director of Clinical Affairs is responsible for providing strategic direction and oversight for all functional activities involving the execution of TriVascular’s global clinical programs. The Director provides leadership and direction to the Clinical Affairs team, and is responsible for conducting studies in compliance with FDA and other International Regulations. This includes ensuring that the appropriate infrastructure, including policies and procedures, are in place to meet all clinical and regulatory requirements and achieve the global business objectives.
• Develops U.S. and international clinical strategies to achieve clinical objectives that are in alignment with the overall business goals.
• Overall management of all phases of clinical programs from start-up through close-out.
• Represents Clinical Affairs on cross-functional project teams and collaborates closely with Clinical Marketing, Regulatory, Quality and R&D.
• Selects and oversees external vendors, including contract research organizations (CRO), Central Institutional Review Boards (IRB), and Core Laboratories.
• Prepares clinical study protocols, case report forms (CRF), statistical analysis plans, data management plans, and monitoring plans.
• Oversight of the Data Safety Monitoring Board (DSMB) and Clinical Events Committee (CEC).
• Responsible for developing, monitoring and reporting metrics designed to improve and assess trial performance, including speed and effectiveness of site start-up, training, speed and accuracy of screening, recruitment, protocol adherence, data collection and safety reporting.
• Prepares clinical trial budgets, project plans and deliverables for each clinical program and leads the team to achieve those objectives.
• Develops an efficient and organized system for updating senior management and staff on clinical study progress.
• Review and approve Document Change Orders (DCO) with clinical data content on behalf of Clinical Affairs.
• Provides leadership and oversight of all Clinical Affairs personnel including recruiting, hiring, performance reviews, development, and project assignments.
• Bachelor’s degree and/or advanced degree in nursing, medical science and/or a related discipline or equivalent work experience.
• 10 years of experience in Clinical Affairs with a medical device company, preferably with implantable Abdominal Aortic Aneurysm (AAA) or other peripheral vascular devices.
• Demonstrated leadership skills and the ability to mentor, coach and develop employees in a fast-paced, team oriented organization.
• Excellent verbal/written communication, teamwork, and interpersonal skills across multiple functions.
• Strong project management skills.
• Established credibility and reputation within the profession.
• Thorough knowledge FDA and other International Regulations, including: 21 CFR Part 820, ISO 13485, CMDCAS, and Good Clinical Practice (GCP) Guidelines.
• Willingness to travel approximately 25-40% (U.S. and International), as project needs require, and to participate in Clinical Affairs activities outside of normal business hours.
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