Clinical Compliance Business Analyst - IT Systems

Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Compliance Business Analyst to join our System Validation team. The BA will work with internal business users in other Medpace departments to validate third-party software applications. These applications include, but are not limited to, analytical instrument software and custom calculation Excel spreadsheets. The BA will manage these projects, facilitating and supporting the business users in defining requirements and writing/executing test scripts.

• Assist business users in defining user requirements and configuration specifications for regulated activity performed in third-party software applications;
• Assist business users in developing and executing acceptance test scripts for third-party software applications;
• Write Validation Plans and Summary Reports for validation projects conducted for third-party software applications;
• Proactively maintain in-depth knowledge of regulatory requirements and manage 21 CFR Part 11 Compliance Assessments for each regulated third-party software application;
• Coordinate with vendors and/or service providers contracted to perform validation activities to ensure compliance with Medpace SOPs and regulatory guidance;
• Provide guidance as needed to ongoing risk assessments and/or ensuring procedural controls are in place to mitigate risk and maintain compliance;
• Assist in gathering evidence during sponsor audits and regulatory inspections.

• Bachelor’s degree or higher in a Clinical, Science, or Technical field;
• Proven ability to manage projects.
• Excellent communication skills, and ability to foster and maintain relationships with non-technical business users;
• Excellent writing skills;
• Competent in eliciting requirements from non-technical domain experts;
• Knowledge of system validation and software testing methodologies (experience in pharmaceutical GxP environments is a plus!);
• Knowledge of risk management strategies, and adapting testing strategy accordingly.

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