Lead, Clinical Operations Full Time

Responsibilities:

• Conducts trials from start-up to close-out.
• Ensures high-quality trial data and operational excellence.
• Develops, analyses, and reports clinical program metrics.
• Ensures study deliverables are on time and within budget.
• Contributes to protocol and study documentation development.
• Communicates trial status, issues, and lessons learned.
• Participates in CRO and vendor selection and contracting.
• Oversees financial reporting for assigned projects.
• Manages relationships with CROs, vendors, and investigators.
• Identifies and mitigates vendor performance risks.
• Develops SOPs and standardized clinical operation forms.
• Provides leadership and support to team members.

Requirements:

• BS/BA degree in science or health-related field preferred.
• 8+ years of clinical operations experience.
• Experience in global clinical trial operations.
• Strong project management and problem-solving skills.
• Ability to manage priorities and multi-task effectively.
• Knowledge of GCP, ICH, and FDA regulations.
• Ability to travel up to 20% domestically and internationally.
• Ability to work independently and make risk-based decisions.
• Therapeutic experience in rare diseases/CNS preferred.

Benefits:

• Remote friendly work environment.
• Must reside and work within the U.S.
• Opportunities for career development and training.
• Attendance at company-related events and travel.
• Adheres to information security and confidentiality policies.