Clinical Research Manager

Thermo Fisher Scientific seeks a Clinical Research Manager to oversee clinical trials in inpatient and outpatient settings. The role involves managing study operations, coordinating between stakeholders, ensuring regulatory compliance, and maintaining project timelines and budgets.

Responsibilities

• Serve as primary point of contact for project team on clinical site-related study aspects
• Manage clinical and administrative project components including site setup, recruitment, and data collection
• Handle IRB submissions, informed consent forms, adverse event notifications, and regulatory documentation
• Develop and maintain study risk registers with mitigation plans reviewed by safety committees
• Coordinate with finance to manage study budgets while meeting sponsor requirements

Requirements

• Bachelor's degree or equivalent formal academic/vocational qualification
• 2+ years of related clinical research or study operations experience
• Knowledge of Phase I processes and clinical study operations
• Understanding of FDA regulations and ICH GCP guidelines
• Proficiency with Microsoft Office applications
• Strong written and verbal communication skills
• Solid organizational and multi-tasking abilities