Senior Clinical Compliance Manager - Remote

Overview

We are seeking a Sr. Clinical Compliance Manager to operate as the liaison between Clinical Operations, Quality Assurance and external vendors, supporting compliance and inspection readiness strategy.

In Short

• Act as a liaison between Clinical Operations and Quality Assurance.
• Support day-to-day compliance and inspection readiness.
• Manage trial-specific training and SOP management.
• Ensure adherence to company processes.
• Oversee training and learning management systems.
• Support inspection readiness exercises.
• Collaborate on internal audits and mock inspections.
• Lead strategic initiatives for operational excellence.
• Requires up to 30% travel.
• Must have a bachelor’s degree and 10 years of experience.

Requirements

• Bachelor's degree and relevant professional experience.
• 10 years of clinical trial management experience.
• Knowledge of ICH, GCP, and regulatory authority regulations.
• Experience in SOP management in the biotech industry.
• Strong leadership and management skills.
• Self-direction and problem-solving abilities.
• Experience in full-cycle drug development.
• Ability to work collaboratively in a team environment.
• Highly organized with attention to detail.
• Effective communication skills for presentations.

Benefits

• Great culture based on C.O.R.E. values.
• Fast-paced, dynamic work environment.
• Market competitive compensation and benefits.
• Flexible PTO.
• Company-wide shutdowns each year.
• Commitment to professional growth and development.
• Regular in-person team meetings.