Position Summary

The Clinical Trial Manager will oversee all aspects of clinical trials from initiation to closure. The ideal candidate will have extensive experience managing complex clinical studies independently while ensuring compliance with study protocols, SOPs, and regulatory requirements.

Responsibilities

• Manage the execution and conduct of all aspects of complex clinical studies, ensuring adherence to timelines, costs, and quality metrics.
• Select and manage vendors/CROs effectively, ensuring compliance and the successful delivery of project milestones within budget and timelines.
• Collaborate closely with investigative site personnel, CROs, and other study vendors to maintain project integrity.
• Oversee study contracting, budget management, forecasting, accruals, and the payment process for all clinical trial vendors, including investigational sites.
• Lead study-related activities including protocol and informed consent preparation, and investigator selection.
• Ensure all documentation is maintained in accordance with regulatory requirements and company policies.
• Conduct regular project meetings to ensure alignment among all stakeholders and address any issues that arise.

Requirements

• Bachelor's degree in life sciences or a related field; advanced degree preferred.
• A minimum of 5 years of experience in clinical trial management, including experience with complex studies.
• Strong understanding of clinical trial processes, regulatory requirements, and GCP guidelines.
• Proficient in project management tools and methodologies.
• Excellent communication and interpersonal skills, with the ability to work collaboratively across teams.
• Strong analytical and problem-solving abilities.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with employer matching.
• Generous paid time off and holiday schedule.
• Opportunities for professional development and career advancement.
• A supportive and collaborative work environment.