System Design Analyst I, Clinical Data Systems

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

📋 Description

• Develop and implement new clinical systems and integrations, such as EDC and IRT, while executing necessary system modifications.

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

• Recognize potential timeline or quality risks and formulate appropriate solutions.

• Ensure that study protocol requirements are incorporated into system designs and that standardized data practices are utilized.

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

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

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

• Align work products with both upstream and downstream dependencies.

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

• Stay updated on changing regulations, guidelines, and policies pertaining to clinical development.

• Mentor and coach Data Science Associates.

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

⛳️ Requirements

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

• A Master's degree is preferred.

• Over 3 years of experience in clinical technology, including EDC, IRT, or ePRO; or more than 5 years in a similar technical or clinical development position.

• Familiarity with commonly used industry design and development tools is preferred.

• Proven understanding of the clinical trial process.

• Knowledge of CDASH and SDTM standards.

• Ability to influence others without direct authority.

• Strong communication skills.

• Proficient analytical skills.

🏝️ Benefits

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

• Medical, dental, and vision insurance coverage.

• 401(k) retirement plan.

• Short-term incentive programs.

• Option for remote work.

• Commitment to equal opportunity employment.

• Reasonable accommodations available for applicants from the US and Puerto Rico.