Clinical Systems Specialist

Overview

• Support lifecycle management of clinical systems for global development operations.
• Provide expertise in clinical trial management, systems, reporting, and vendor management.
• Collaborate with IT and Quality Systems teams for system upgrades and bug fixes.
• Manage vendor relationships to ensure optimal system performance and issue resolution.
• Participate in planning, design, configuration, and deployment of clinical systems.
• Ensure compliance with clinical trial protocols and regulatory requirements.
• Develop and execute user acceptance testing scenarios for clinical systems.
• Support administration activities including user access management.

Key Responsibilities & Duties

• Plan, design, configure, and deploy clinical systems and enhancements.
• Analyze system requirements and perform user acceptance testing.
• Collaborate with stakeholders for system upgrades and bug fixes.
• Manage vendor relationships to ensure system performance and issue resolution.
• Support clinical systems administration activities like user access review.
• Ensure compliance with Good Clinical Practice and 21 CFR Part 11.
• Provide expertise in clinical trial management and systems reporting.
• Maintain positive relationships with peers and management.

Job Requirements

• Bachelor’s degree in scientific or technical discipline preferred.
• Minimum 2 years of experience with clinical systems like eCOA, IRT, and CTMS.
• Understanding of clinical trial protocols and operations.
• Knowledge of regulatory requirements such as Good Clinical Practice and 21 CFR Part 11.
• Experience in user acceptance testing for computer systems.
• Proficiency in MS applications like SharePoint, Outlook, Word, Excel, and PowerPoint.
• Strong analytical, problem-solving, and organizational skills.
• Ability to manage multiple tasks and meet time demands effectively.