Senior Manager, Inspection Readiness, Clinical Operations - Remote

Overview

The Senior Manager, Inspection Readiness, Business Operations, Clinical Operations will be responsible for developing and implementing a robust, proactive inspection readiness program for the Clinical Operations function that ensures compliance with global regulatory requirements and Good Clinical Practice (GCP).

In Short

• Develop and manage inspection readiness strategies across clinical trials.
• Serve as primary contact during sponsor or regulatory inspections.
• Track and report inspection readiness KPIs and gap assessments.
• Maintain a state of constant inspection readiness across all trials.
• Deliver targeted GCP and inspection readiness training.
• Advise on investigations and quality events within QA/QE/CAPA processes.
• Lead operational excellence initiatives within Clinical Operations.
• Develop standard operating procedures (SOP) and work instructions.
• Implement onboarding and training for new processes.
• Mentor junior team members on quality mindset and compliance practices.

Requirements

• Bachelor’s degree, preferably in a scientific field.
• 8+ years of related industry experience at a Sponsor or CRO.
• Understanding of clinical trial terminology and activities.
• Thorough understanding of ICH GCP guidelines.
• Proficient in developing and writing SOPs.
• Ability to handle multiple projects with attention to detail.
• Excellent interpersonal communication and negotiation skills.
• Strong verbal and written communication skills.
• Self-motivated and able to work independently or in a team.
• Problem solving and decision-making skills.

Benefits

• Competitive market-based salary.
• Participation in stock programs.
• Performance-based bonus.
• Comprehensive benefits package.
• Opportunity for professional growth.