Clinical Study Manager

About the role

The Clinical Study Manager at Arthrex, Inc. supports clinical research studies from start to finish, ensuring compliance and efficient study execution.

Responsibilities

• Manage clinical research studies from intake through closeout
• Monitor the management of and collection of data
• Ensure compliance with CTMS, eTMF filing, and EDC systems
• Secure essential vendor documents and track timelines, milestones, and quality metrics
• Lead contract and budget negotiations, vendor onboarding, and site training
• Track and report on the progress of assigned clinical studies
• Order, distribute, and track study supplies
• Maintain all pertinent study correspondences
• Develop clinical research standard operating procedures and work instructions
• Coordinate and lead Investigational site training and meetings
• Identify and mitigate quality risks and issues associated with assigned studies/activities
• Aid site coordinators with IRB submissions as necessary
• Ensure operational aspects of studies comply with ethical and government standards, GCP's, and SOPs
• Participate in internal process audits, vendor and study site quality audits, and regulatory inspections
• Inform management and stakeholders on progress of assigned clinical study metrics and other project-related information

Requirements

• Knowledge of ICH guidelines and FDA Regulations relevant to clinical studies
• Master’s Degree in health, life sciences, or related field + 5 years of Clinical Research experience
• Pre-market IDE or IND study experience preferred
• One year of industry-sponsored or CRO employment
• Proficient software skills: Word, Excel, PowerPoint, database

Qualifications

• Bachelor’s degree in health, life sciences, or other relevant field of study + 4 years of Clinical Research experience

Skills

• Comprehension of medical terminology or ability to reference literature for understanding
• PC, database, research tools, internet research tools