Senior EDC Lead

About the role

The Senior EDC Lead is a key member of the Clinical Data Strategy Organization within AbbVie Data Science. This role is responsible for developing and maintaining common data standards, ensuring system designs comply with standards and protocol requirements, and delivering high-quality clinical trial systems.

Responsibilities

• Develops and maintains methodologies for designing and developing clinical trial systems, benchmarking against industry standards.
• Ensures systems are designed to optimize functionality, end user experience, and data flow.
• Achieves consistency in TA- and program-level clinical systems design.
• On-time design and delivery of new clinical systems, integrations, and required changes to clinical systems (EDC, IRT, ePRO).
• Utilizes project management tools to track study progress and plan work.
• Anticipates and identifies issues affecting timelines or quality, and develops solutions.
• Collaborates with and influences CDO and cross-functional teams to achieve program and study objectives.
• Synchronizes assigned work product with upstream and downstream dependencies.
• Ensures compliance with federal regulations, GCPs, ICH Guidelines, AbbVie SOPs, and functional quality standards.
• Learns and leads in innovation and process improvement initiatives.

Qualifications

• Bachelor’s degree in business, management information systems, computer science, life sciences, or equivalent.
• Master’s degree preferred.
• At least 5 years of hands-on technical experience in Study build in EDC, with a focus on Medidata RAVE.
• In-depth knowledge of clinical trial processes.
• In-depth knowledge of CDASH and SDTM.
• Demonstrated ability to contribute to and advance organizational initiatives.
• Strong influence and mentoring skills.
• Effective communication and analytical skills.

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) plan
• Short-term incentive programs

Equal Opportunity Employer

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. We offer a comprehensive package of benefits, including a robust training and development program.