Systems Design Analyst II

About the role

The Systems Design Analyst II is responsible for developing and maintaining clinical trial systems, ensuring compliance with industry standards and regulatory requirements. They also lead innovation and process improvement initiatives within the Data and Statistical Sciences team.

Responsibilities

• Develops and maintains clinical trial system designs that comply with industry standards and regulatory requirements.
• Ensures consistency in system design across different studies and programs.
• Manages the development and delivery of new clinical systems, integrations, and necessary changes to existing systems.
• Works collaboratively with DSS and other cross-functional teams to ensure alignment with program and study objectives.
• Maintains adherence to federal regulations, GCPs, ICH Guidelines, and AbbVie SOPs.
• Coaches and mentors team members, contributing to their skill development.
• Led innovation and process improvement initiatives within the team.

Requirements

• Bachelor’s degree in business, management information systems, computer science, life sciences, or equivalent.
• At least 5 years of clinical technology experience (EDC, IRT, ePRO) or 7 years of experience in a similar technical role or clinical development role.
• In-depth knowledge of clinical trial processes and CDASH/SDTM.
• Demonstrated performance and leadership in contributing to organizational initiatives and advancements.
• Ability to influence others without direct authority.
• Effective communication and analytical skills.

Qualifications

• Master’s degree preferred.

Skills

• Strong understanding of clinical trial processes and CDASH/SDTM.
• Experience with common industry design and development tools.
• Excellent problem-solving and critical thinking skills.
• Strong interpersonal and communication skills.

Benefits

Comprehensive benefits package including paid time off, medical/dental/vision insurance, and a 401(k).

Pay

$109,500 - $208,500 USD

Schedule

Hybrid