System Design Analyst I, Clinical Data Systems

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Develop and implement new clinical systems and facilitate integrations between platforms, such as EDC and IRT.

• Execute necessary modifications to clinical systems.

• Utilize project management tools to monitor study progress and organize workload.

• Proactively identify and address issues that may impact timelines or quality, and create effective solutions.

• Ensure that the study protocol requirements are accurately represented in system designs and adhere to common data standards.

• Define system specifications to enhance functionality, user experience, and data flow.

• Maintain consistency at both the therapeutic-area and program levels.

• Guide DSS and cross-functional team members in achieving program and study goals.

• Coordinate assigned work products with related upstream and downstream tasks.

• Ensure compliance with regulations, GCPs, ICH Guidelines, SOPs, and functional quality benchmarks.

• Stay updated with changing local regulations, guidelines, and policies concerning clinical development.

• Mentor and provide guidance to Data Science Associates.

• Engage in DSS and cross-functional initiatives focused on innovation and process enhancement.

⛳️ Requirements

• Bachelor’s degree in business, management information systems, computer science, life sciences, or a related field.

• Master’s degree is preferred.

• A minimum of 3 years of clinical technology experience (e.g., EDC, IRT, ePRO), or over 5 years in a comparable technical or clinical development role.

• Preferred familiarity with standard industry design and development tools.

• Proven understanding of the clinical trial process.

• Knowledge of CDASH and SDTM.

• Ability to influence peers without direct authority.

• Strong communication skills.

• Excellent analytical skills.

• Understanding of federal regulations, applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and standard operating procedures.

🏝️ Benefits

• Paid time off, including vacation, holidays, and sick leave.

• Medical, dental, and vision insurance.

• 401(k) retirement plan.

• Short-term incentive programs.

• Equal opportunity employer benefits and support for reasonable accommodations.