Clinical Trial Manager (Biotech)

TL;DR

Clinical Trial Manager (Biotech): Coordinating the operational execution of late-stage clinical trials with an accent on CRO and vendor management. Focus on tracking study deliverables, ensuring TMF completeness, and managing regulatory documentation to maintain inspection readiness.

Location: Remote. Must be able to travel up to 20% of the time, domestically and/or internationally.

Salary: $127,000 – $170,000 USD

Company

A clinical-stage generative biology company pioneering AI-driven drug design and development to create protein-based medicines.

What you will do

• Serve as the primary operational point of contact for CROs and vendors, tracking timelines and flagging risks to leadership.
• Review CRO-generated study documents (monitoring reports, protocol deviations, TMF entries) for quality and completeness.
• Coordinate study startup activities, including site activation tracking and regulatory document collection.
• Maintain study trackers, action logs, and distribute operational metrics to clinical operations leadership.
• Oversee safety reporting coordination and TMF inspection readiness activities.
• Manage vendor invoice review and budget tracking by reconciling activities against contracts.

Requirements

• Bachelor’s degree in a scientific or health-related field.
• 6+ years of experience in clinical operations, clinical research, or a related field.
• Foundational understanding of GCP, ICH guidelines, and clinical trial processes.
• Experience coordinating with CROs or clinical vendors.
• Familiarity with clinical trial systems such as CTMS, EDC, and eTMF platforms.
• Ability to travel up to 20% of the time, domestically and/or internationally.

Nice to have

• Sponsor-side experience.
• Familiarity with oncology, immunology, and/or respiratory therapeutic areas.

Culture & Benefits

• Annual bonus and equity compensation.
• Competitive benefits package.
• Remote work arrangement.
• Collaborative environment integrating machine learning with large-scale experimentation.