System Design Analyst I, Clinical Data Systems

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

📋 Description

• Design and implement new clinical systems, system integrations, and modifications to clinical systems such as EDC and IRT.

• Utilize project management tools to monitor study progress and plan tasks.

• Identify challenges impacting timelines or quality and devise effective solutions.

• Ensure that study protocol requirements are incorporated into system designs while adhering to common data standards.

• Enhance systems for improved functionality, user experience, and data flow.

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

• Collaborate with DSS and cross-functional team members to meet program and study goals.

• Align assigned work products with both upstream and downstream dependencies.

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

• Keep abreast of evolving regulations, guidelines, and policies relevant to clinical development.

• Mentor and coach Data Science Associates.

• Engage in innovation and process improvement initiatives.

⛳️ Requirements

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

• A Master's degree is preferred.

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

• Familiarity with common industry design and development tools is preferred.

• Proven understanding of clinical trial processes.

• Knowledge of CDASH and SDTM standards.

• Ability to influence stakeholders without direct authority.

• Strong communication skills.

• Excellent analytical skills.

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Equal opportunity employer benefits and support for reasonable accommodations.