Regulatory Submissions (Study Start-up) Manager

Overview

In this role you will spearhead regulatory submissions and global start-up activities within Clinical Operations. You will ensure quality and compliance of submission documents, site essential documents, and informed consent forms. You will apply regulatory knowledge to proactively resolve start-up challenges and participate in bid defenses, meetings, and audits. You will collaborate with cross-functional teams to accelerate clinical development and support the company’s mission to bring safe therapeutics to market.

Pay / Benefits

• Competitive compensation programs
• Comprehensive health, wellness, retirement, and PTO benefits
• Office based culture with occasional WFH
• Company-sponsored social events
• On-site mentors and development programs

Responsibilities

• Manage global start-up processes end-to-end
• Perform quality checks on submission documents and site essential documents
• Prepare and approve informed consent forms
• Review regulations to identify proactive solutions to start-up issues
• Present during bid defenses, capabilities meetings, and audits

Key requirements

• Extensive experience in clinical research, preferably with a CRO
• Experience may include CRA or project management
• Knowledge and experience of Clinical Trial Applications within Europe
• Strong oral and written communication skills
• Team oriented approach and strong leadership skills
• team-oriented
• strong leadership
• excellent written and verbal communication
• regulatory submissions management
• global start-up processes
• informed consent form preparation

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