System Design Analyst I, Clinical Data Systems

🔥 5 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $78.5k - $141k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧐 Analyst

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• Design and deliver new clinical systems and integrations, including EDC and IRT, and implement required system changes • Use project management tools to track study progress and plan work • Identify timeline or quality risks and develop solutions • Ensure study protocol requirements are reflected in system designs and common data standards are used • Optimize systems for functionality, end-user experience, and data flow • Ensure therapeutic-area and program-level consistency • Collaborate with DSS and cross-functional team members to achieve program and study objectives • Synchronize work products with upstream and downstream dependencies • Ensure adherence to federal and local regulations, GCPs, ICH Guidelines, SOPs, and functional quality standards • Monitor evolving regulations, guidelines, and policies related to clinical development • Coach and mentor Data Science Associates • Participate in DSS and cross-functional innovation and process-improvement initiatives

🎯 Requirements

• Bachelor's degree in business, management information systems, computer science, life sciences, or equivalent • Master's degree preferred • 3+ years of clinical technology experience, such as EDC, IRT, or ePRO; or 5+ years of experience in a similar technical or clinical development role • Experience with common industry design and development tools preferred • Demonstrated understanding of the clinical trial process • Knowledge of CDASH and SDTM • Ability to influence others without direct authority • Effective communication skills • Effective analytical skills

🏖️ Benefits

• Paid time off, including vacation, holidays, and sick leave • Medical, dental, and vision insurance • 401(k) • Short-term incentive programs • Remote work option • Equal opportunity employment • Reasonable accommodation for US and Puerto Rico applicants