System Design Analyst I, Clinical Data Systems

About AbbVie

Qualifications

• Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred
• Must have 3+ years of clinical technology experience (e.g., EDC, IRT, ePRO ) or 5+ years of experience in a similar technical role or in a clinical development role. Experience with common industry design and development tools preferred
• Demonstrated understanding of clinical trial process
• Knowledge of CDASH and SDTM
• Demonstrated ability to influence of others without direct authority
• Demonstrated effective communication skills
• Demonstrated effective analytical skills

Responsibilities

• Accountable for the on-time design and delivery of new clinical systems, integrations between systems, as well any required changes to clinical systems (must have, EDC, IRT ). Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
• Ensures that the requirements of each study protocol are reflected in systems designs and that common data standards are used
• Ensures that systems are specified to optimize on functionality, end user experience, and data flow
• Ensures that TA- and program-level consistency is achieved
• Interacts with and influences DSS and cross-functional team members to achieve program and study objectives. Ensures that assigned work product is synchronized with upstream and downstream dependencies
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
• Responsible for coaching and mentoring Data Science Associates
• Participates in DSS and cross-functional innovation and process improvement initiatives
• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.
• Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
• AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.