Clinical Systems Specialist

Overview

• Support lifecycle management of clinical systems for global development operations, ensuring optimal performance and compliance.
• Collaborate with cross-functional teams to enhance clinical systems and address operational needs.
• Provide expertise in clinical trial management, reporting, and vendor relationship management.
• Contribute to system planning, design, configuration, and deployment activities.
• Perform user acceptance testing and support system upgrades and bug fixes.
• Ensure compliance with clinical trial regulations and standards.
• Manage user access and administration activities for clinical systems.
• Leverage technical skills to support database and reporting needs.

Key Responsibilities & Duties

• Plan, design, configure, and deploy new clinical systems and enhance existing applications.
• Analyze system requirements and define user acceptance scenarios for testing.
• Collaborate with IT and quality systems teams for system upgrades and bug fixes.
• Act as a subject matter expert for clinical systems within the organization.
• Manage vendor relationships to ensure optimal system performance and address issues.
• Support user access management and conduct regular reviews.
• Develop and execute user acceptance testing scenarios for clinical systems.
• Ensure compliance with Good Clinical Practice and regulatory standards.

Job Requirements

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