Clinical Trial Study Manager

Responsibilities:

• Develop Clinical Trial Plans: The Clinical Trial Study Manager is responsible for creating clinical trial plans that define the objectives, methods, timelines, and budget for the clinical trial.
• Coordinate Trial Activities: The Clinical Trial Study Manager coordinates all activities related to the clinical trial, including study design, patient recruitment, study implementation, data collection, and analysis.
• Ensure Compliance: The Clinical Trial Study Manager ensures that all aspects of the clinical trial comply with relevant regulations, guidelines, and ethical principles.
• Manage Study Budget: The Clinical Trial Study Manager is responsible for managing the budget for the clinical trial, including forecasting costs, managing expenses, and ensuring that the trial stays within budget.
• Manage Study Timeline: The Clinical Trial Study Manager is responsible for managing the timeline for the clinical trial, including setting milestones, monitoring progress, and ensuring that the trial stays on schedule.
• Collaborate with cross-functional teams: The Clinical Trial Study Manager collaborates with cross-functional teams, including clinical operations, regulatory affairs, quality assurance, and product development teams to ensure the successful completion of the clinical trial.
• Monitor Study Progress: The Clinical Trial Study Manager monitors the progress of the clinical trial and ensures that any issues or deviations from the study protocol are identified and addressed promptly.
• Prepare Study Reports: The Clinical Trial Study Manager prepares study reports that summarize the results of the clinical trial and make recommendations for future studies.
• Communicate Study Results: The Clinical Trial Study Manager communicates the results of the clinical trial to internal and external stakeholders, including senior management, regulatory agencies, and study participants.
• Continuous Improvement: The Clinical Trial Study Manager continuously evaluates and improves the clinical trial process by identifying areas for improvement and implementing best practices to ensure the successful completion of future clinical trials.

Qualifications:

• Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
• May have practical knowledge of project management.
• Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.