Clinical Systems Specialist

Overview

• Drive clinical systems lifecycle management to support global development operations, ensuring optimal performance and compliance with industry standards.
• Collaborate with cross-functional teams to enhance clinical systems and address operational needs effectively.
• Provide expertise in clinical trial management, reporting, and vendor relationship management for system optimization.
• Contribute to system planning, design, configuration, deployment, and enhancement activities to meet organizational goals.
• Perform user acceptance testing and support system upgrades and bug fixes to ensure seamless functionality.
• Ensure compliance with clinical trial regulations and standards, maintaining data integrity and security.
• Manage user access and administration activities for clinical systems to support operational efficiency.
• Leverage technical skills to support database and reporting needs, driving informed decision-making.

Key Responsibilities & Duties

• Plan, design, configure, and deploy new clinical systems while enhancing existing applications for improved functionality.
• Analyze system requirements and define user acceptance scenarios to ensure comprehensive testing coverage.
• Collaborate with IT and quality systems teams to implement system upgrades and resolve technical issues.
• Act as a subject matter expert for clinical systems, providing guidance and training to stakeholders.
• Manage vendor relationships to ensure optimal system performance and address operational challenges.
• Support user access management and conduct regular reviews to maintain system security.
• Develop and execute user acceptance testing scenarios to validate system functionality and compliance.
• Ensure adherence to Good Clinical Practice and regulatory standards throughout system operations.

Job Requirements

• Bachelor’s degree in a scientific or technical discipline is preferred for this role.
• Minimum of 2 years of experience with clinical systems such as eCOA, IRT, and CTMS.
• Comprehensive understanding of clinical trial protocols and operational workflows.
• Knowledge of regulatory standards including Good Clinical Practice and 21 CFR Part 11.
• Proficiency in developing and executing user acceptance testing scenarios for clinical systems.
• Excellent written and verbal communication skills to facilitate collaboration and reporting.
• Strong analytical, problem-solving, and organizational abilities to manage complex tasks.
• Proficiency in MS applications such as SharePoint, Outlook, Word, Excel, and PowerPoint.