Clinical Trial Manager - Remote

Overview

The Clinical Trial Manager (CTM) will support successful and timely start-up and completion of clinical trials and is a key member of the Organization of Chief Medical Officer (OCMO) Global Clinical Affairs team.

In Short

• Manage all clinical operational aspects of IVD clinical trials from inception through close-out.
• Serve as main point of contact for internal and external study stakeholders.
• Identify, evaluate, and oversee qualification and contracting for study investigators and sites.
• Ensure trial master file is established and maintained per ICH E6(R2).
• Support and oversee study-related work of Clinical Research Associates.
• Manage study deliverables and track study metrics.
• Participate in data management activities and lead organizational process development.
• Provide guidance and mentorship to junior team members.
• Monitor and review study budget and data management activities.
• Demonstrate ability to influence others to achieve positive results.

Requirements

• Bachelor's degree or higher, or equivalent credentials.
• Knowledge of GCP, ICH guidelines, and clinical regulatory requirements.
• Strong interpersonal, organizational, and prioritization skills.
• Ability to work independently in a fast-paced environment.
• Proficient with Microsoft PowerPoint, Excel, and Word.
• 1+ year of direct clinical study management experience.
• Strong work ethic and ability to deliver tasks on time.
• People management skills.
• Ability to manage complex projects.
• Travel may be required up to 30%.

Benefits

• Full-time position with remote work option.
• Eligibility for bonus, stock, and benefits.
• Diversity and inclusion in the workplace.
• Support for candidates with disabilities.
• Opportunity to work with a global leader in laboratory and clinical technologies.