Job Description

Purpose:

AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation.   This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.

Responsibilities:

Drive the Overall eCRF Library Development and Maintenance Project. Proactively Identify, Manage and Deliver Individual Components of Library working with various stake holders.

Develop Process and Tools to Ensure Consistency in Process, Implementation and Quality of CDASH and Abbvie Data Collection Standards.

•Actively participates in the development of common data standards and ensures EDC systems designs comply with the standards, as well as with associated protocol requirements.   Ensures that the design team utilizes standards.

•Establishes and maintains methodology used by the team to design and develop EDC systems, benchmarking against industry standards.   Ensures that systems are specified to optimize functionality, end user experience, and data flow. Ensures that the design team meets these expectations.

•Ensures that TA- and program-level consistency is achieved by the design team

•Accountable for the on-time design and delivery of new clinical systems, integrations between systems, as well any required changes to EDC systems.   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.

•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 members of the team, as well as contributes to their skill development

•Leads DSS and cross-functional innovation and process improvement initiatives

Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day)