Clinical Systems Project Manager

Job Summary

Managing and optimizing clinical systems for clinical trials, the full-time IRT Project Manager / Lead Clinical Systems Specialist will oversee the implementation and management of IRT solutions, ensuring compliance and operational efficiency in a remote or office-based environment.

Key responsibilities:

• Leading the implementation, configuration, and maintenance of clinical trial management systems (CTMS) and other clinical platforms
• Collaborating with clinical and IT teams to ensure system functionality aligns with study protocols and operational requirements
• Managing the planning, execution, and delivery of IRT projects, ensuring alignment with clinical trial requirements and regulatory standards

Required qualifications:

• Bachelor's degree in information technology, life sciences, project management, or a related field; advanced degree preferred
• Extensive experience in managing clinical trial systems (e.g., CTMS, EDC, IWRS) and understanding of clinical operations workflows
• Strong technical skills, with proficiency in system configuration, data integration, and troubleshooting
• In-depth knowledge of regulatory requirements related to clinical data and system compliance (e.g., GCP, FDA 21 CFR Part 11)
• Excellent problem-solving and leadership skills, with the ability to manage cross-functional teams and complex projects