Company:
AbbVie
Location: North Chicago
Closing Date: 16/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Job Description
AbbVie Clinical Data Strategy and Operations (CDSO) 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.
Resposibilities:
Ensures that the requirements of each study protocol are reflected in the Electronic Data Captures (EDC) design and that common data standards are used
Ensures that EDC is specified to optimize on functionality, end user experience, and data flow
Accountable for the on-time design and delivery of new EDC systems, integrations between EDC and other applicable systems (e.g. IRT)., as well any required changes to EDC. 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 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 CDSO Associates
Participates in DSS and cross-functional innovation and process improvement initiatives
AbbVie Clinical Data Strategy and Operations (CDSO) 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.
Resposibilities:
Ensures that the requirements of each study protocol are reflected in the Electronic Data Captures (EDC) design and that common data standards are used
Ensures that EDC is specified to optimize on functionality, end user experience, and data flow
Accountable for the on-time design and delivery of new EDC systems, integrations between EDC and other applicable systems (e.g. IRT)., as well any required changes to EDC. 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 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 CDSO Associates
Participates in DSS and cross-functional innovation and process improvement initiatives
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