Head of Clinical Operations & Study Management

Certara; United States; Remote; USD 180,000 - 280,000; Full time

Job summary

Certara is seeking a Senior Director for Clinical Operations in the United States to lead strategic clinical operations initiatives across studies and vendors. The role emphasizes alignment of strategy, goals, and execution, with possible direct reports.

The incumbent will oversee study management teams, CRO selection, audit readiness, and sponsor oversight from startup to database lock, ensuring regulatory compliance and quality throughout drug development.

Qualifications

• Bachelor's degree required; science background preferred.
• Fifteen years in CRO/pharma/biotech with Phase I experience.
• Experience managing CROs, vendors, and budgets.
• Understanding of ICH/GCP and regulatory compliance.

Responsibilities

• Leads Certara Clinical Operations and Study Management activities.
• Manages CRO/vendor selection, scope, budgets, and timelines.
• Oversees study planning to meet client objectives and budgets.
• Ensures studies comply with SOPs, regulations, and QA standards.
• Provides sponsor oversight of Phase 1 studies through database lock.
• Develops and reviews study documents including ICFs, IBs, and INDs.

Skills

Communication skills

Leadership

Project management

Analytical skills

MS Office

Education

Bachelor's degree

Science background preferred

Tools

MS Project

SharePoint

Excel

Job description

Certara is seeking a Senior Director for Clinical Operations in the United States to lead strategic clinical operations initiatives across studies and vendors. The role emphasizes alignment of strategy, goals, and execution, with possible direct reports.

The incumbent will oversee study management teams, CRO selection, audit readiness, and sponsor oversight from startup to database lock, ensuring regulatory compliance and quality throughout drug development.