LivaNova

Compensation

Full Description

Job Description: • Assist with the management and execution of clinical studies in accordance with applicable regulations • Coordinate project deliverables such as team meetings, budgets, and timelines • Assist with the development and planning of clinical study strategies and protocols • Oversee and provide clinical input for the design of Case Report Forms and electronic databases • Assist with preparation of regulatory applications and documentation needed to conduct studies • Monitor or co-monitor clinical study sites for compliance with approved study protocols • Maintain accurate study tracking documents and systems • Prepare and give clinical presentations as required • Support Data Monitoring Committees if applicable • Assist management of study vendors for compliance to study plans Requirements: • Minimum prior work experience of 4+ years as a Clinical Research Nurse or equivalent role supporting clinical trial project management • Knowledge of international regulations and guidelines (ISO14155/GCP) and clinical study design and implementation • Working knowledge of medical terminology • Capability and willingness to learn device function • Ability to interface effectively with medical professionals • Strong analytical and organization skills, with excellent attention to detail and accuracy • Project oversight and tracking capability • Experience with electronic data capture (EDC) and clinical trial management systems (CTMS) • Ability to travel as necessary to clinical centers to establish and manage clinical studies • Experience as a Project Coordinator/Manager is a plus. Benefits: • Health benefits – Medical, Dental, Vision • Personal and Vacation Time • Retirement & Savings Plan (401K) • Employee Stock Purchase Plan • Training & Education Assistance • Bonus Referral Program • Service Awards • Employee Recognition Program • Flexible Work Schedules