Responsibilities

• Oversee clinical operations for a project at a regional or global level, ensuring compliance with study protocols, local regulations, and ICH-GCP guidelines.
• Act as the primary liaison between Clinical Research Associates (CRAs) and the clinical project team.
• Provide training to CRAs specific to project needs and conduct assessment visits to evaluate performance.
• Implement effective enrollment and recruitment strategies to enhance site performance.
• Prepare monitoring plans and other essential documentation related to clinical operations.
• Schedule monitoring visits and track site performance metrics, ensuring timely escalation of issues and corrective actions.
• Develop and review study tools for site and CRA utilization, including visit reports and protocol deviations.
• Support broader objectives for clinical operations and contribute to the success of the clinical project team.

Requirements

• Bachelor's degree in a relevant field; advanced degree preferred.
• Proven experience in clinical operations or project management within a healthcare setting.
• Strong understanding of Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements.
• Excellent communication and interpersonal skills to effectively collaborate with CRAs and stakeholders.
• Ability to analyze data and interpret performance metrics to drive project success.
• Demonstrated leadership skills and the capacity to mentor and train team members.
• Willingness to travel as required to oversee clinical operations across sites.

Benefits

• Competitive salary and comprehensive benefits package.
• Opportunities for professional growth and career advancement.
• Supportive and collaborative work environment.
• Access to ongoing training and development resources.
• Flexible working hours with options for remote work.
• Engagement in meaningful and impactful healthcare projects.