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 execution.

Responsibilities

• Manage clinical research studies from intake through closeout.
• Maintain compliance with CTMS, eTMF, and EDC systems.
• Secure vendor documents and track essential documents.
• Negotiate clinical trial agreements and budgets.
• Lead CRO activities and oversee site operations.
• Track study status, enrollment, regulatory documentation, and site start-up status.
• Order, distribute, and track study supplies.
• Coordinate and lead Investigational site training and meetings.
• Develop and maintain SOPs and work instructions.
• Assist with IRB submissions and ensure compliance with ethical standards.
• Participate in internal process audits and regulatory inspections.
• Report progress on assigned clinical studies to management and stakeholders.

Requirements

• Knowledge of ICH guidelines and FDA regulations relevant to clinical studies.
• Master’s degree in health, life sciences, or related field, or equivalent experience.
• Experience in pre-market IDE or IND studies.
• Industry-sponsored or CRO experience.

Skills

• Software proficiency: Word, Excel, PowerPoint, databases.

Benefits

Arthrex offers a comprehensive benefits package including medical, dental, and vision insurance, life insurance, flexible spending account, supplemental insurance plans, retirement plan, annual bonus, wellness incentive program, free on-site clinics, paid parental leave, and more.