Job Overview
The Director of Clinical Trials plays a vital role in overseeing and managing clinical trials from inception to completion. This position requires a strong understanding of clinical research processes, FDA regulations, and Good Clinical Practice (GCP) guidelines. The ideal candidate will possess leadership skills and be able to supervise teams effectively while ensuring compliance with all regulatory requirements. This role is essential for the successful execution of clinical trials and contributes significantly to the advancement of scientific research.

Duties

• Coordinate and manage all aspects of clinical trial operations, including planning, execution, and reporting.
• Ensure compliance with FDA regulations and GCP standards throughout the trial process.
• Supervise and lead cross-functional teams involved in clinical research activities.
• Develop and maintain study protocols, informed consent documents, and other essential trial documentation.
• Collaborate with investigators, sponsors, and regulatory agencies to facilitate smooth trial operations.
• Monitor trial progress, data collection, and adherence to timelines.
• Conduct training sessions for staff on clinical trial procedures and regulatory requirements.
• Analyze data using SAS or other statistical software to support research findings.
• Assist in the development of research proposals and grant applications.

Requirements

• Bachelor’s degree in a relevant field; advanced degree preferred.
• Proven experience in clinical research or clinical development roles.
• Strong knowledge of FDA regulations, GCP guidelines, and scientific research methodologies.
• Excellent leadership skills with experience supervising teams in a clinical setting.
• Proficiency in SAS or similar statistical analysis software is highly desirable.
• Strong organizational skills with the ability to manage multiple projects simultaneously.
• Exceptional communication skills for effective collaboration with diverse stakeholders.
• A commitment to maintaining high ethical standards in clinical research practices.