Senior Clinical Trial Specialist

Overview

• Provide logistical support for clinical trials, ensuring compliance with SOPs and regulations.
• Collaborate with cross-functional teams to manage site start-up through close-out activities.
• Serve as a subject matter expert for the Clinical Trial Specialist role.
• Mentor and onboard Clinical Trial Associates and Specialists.
• Support vendor management, including contract oversight and forecasting.
• Contribute to team meetings and study management discussions.
• Participate in Trial Master File reviews and maintain essential document lists.
• Develop and maintain study documents, including manuals and study plans.
• Identify and resolve issues, ensuring smooth trial operations.

Key Responsibilities & Duties

• Manage regional sites and CROs under the direction of the Study Lead.
• Oversee vendor contracts, invoicing, and purchase order monitoring.
• Develop and maintain study documents, ensuring accuracy and compliance.
• Contribute to team meetings and provide content for study discussions.
• Review Trial Master File completeness and update essential document lists.
• Mentor and onboard new Clinical Trial Associates and Specialists.
• Serve as a subject matter expert for the Clinical Trial Specialist role.
• Ensure compliance with SOPs and applicable regulations.
• Identify and resolve complex problems to ensure trial success.

Job Requirements

• Bachelor’s degree in a scientific or healthcare discipline required.
• Minimum of 4 years of direct clinical research experience.
• Knowledge of study phases and their application in clinical development.
• Ability to manage multiple tasks and deadlines effectively.
• Strong problem-solving skills for complex issues.
• Excellent relationship-building skills with management and peers.
• Willingness to travel up to 10% as required.
• Self-motivated with the ability to work independently and collaboratively.
• Experience mentoring and onboarding team members is preferred.