Senior Clinical Trial Manager - Remote

Overview

The Senior Clinical Trial Manager is responsible for overseeing all aspects of clinical study management for a gene therapy product, ensuring successful management of complex studies with minimal supervision.

In Short

• Oversee all aspects of clinical trials for gene therapy.
• Manage study planning and execution, including timelines and budgets.
• Lead cross-functional teams and manage vendor relationships.
• Ensure compliance with regulatory requirements.
• Conduct risk assessments and develop contingency plans.
• Communicate effectively with stakeholders about study status and issues.
• Participate in audits and regulatory inspections.
• Travel may be required for this position.
• Foster relationships with study investigators and external partners.
• Act as a clinical subject matter expert.

Requirements

• Bachelor’s degree in a life science.
• Minimum 7 years of clinical experience in biopharma or CRO.
• Expertise in managing global clinical trials.
• Strong understanding of FDA and EU regulations.
• Experience with regulatory agency inspections preferred.
• Strong verbal and written communication skills.
• Ability to multi-task in a fast-paced environment.
• Detail-oriented with a proactive problem-solving approach.
• Experience in clinical data management processes.
• Ability to work collaboratively in a team environment.

Benefits

• Opportunity to work on innovative gene therapies.
• Collaborative and diverse work environment.
• Supportive company culture that values teamwork.
• Professional development opportunities.
• Comprehensive benefits package.