Responsibilities

• Oversee the clinical operations of assigned projects ensuring compliance with study protocols, timelines, and regulatory guidelines.
• Act as a primary liaison between Clinical Research Associates (CRAs) and the clinical project team, facilitating effective communication.
• Provide project-specific training for CRAs to ensure they are equipped to perform their tasks effectively.
• Conduct assessment visits with CRAs to evaluate site performance and adherence to the monitoring plan.
• Implement enrollment and recruitment strategies to enhance study participant engagement and retention.
• Prepare and maintain the monitoring plan and other structural documentation necessary for project execution.
• Oversee the scheduling of monitoring visits and track site and monitoring performance metrics.
• Identify issues and escalate them when necessary, proposing corrective actions to mitigate risks.
• Develop study tools for site and CRA utilization to streamline processes and improve efficiency.
• Review visit reports and track protocol deviations to ensure compliance and quality standards are met.
• Support various objectives for clinical operations and collaborate with the clinical project team to achieve project goals.

Requirements

• Bachelor’s degree in Life Sciences, Nursing, or a related field; advanced degree preferred.
• Minimum of 5 years of experience in clinical operations or clinical trial management.
• Strong understanding of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and local regulations.
• Proven track record in managing clinical trials from initiation through completion.
• Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment.
• Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
• Experience with electronic data capture systems and clinical trial management software.
• Fluency in English; proficiency in additional languages is a plus.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health and wellness benefits.
• Opportunities for professional development and continuing education.
• Flexible working hours and the possibility of remote work.
• A collaborative and supportive work environment.
• Contribution to meaningful projects that enhance patient care and clinical outcomes.