Clinical Data Systems Lead

AbbVie Clinical Data Strategy and Operations is the best-in-class team within its cross-industry peer group. We are 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 a key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences. Responsibilities: Develop a deep understanding of the capabilities and data flow for clinical technologies Support the delivery of clinical technologies for a given program or therapeutic area Track and analyze system timelines and metrics to ensure adherence to project plans, identify and mitigate potential risks and assess performance Develop actionable reports and presentations for stakeholders and senior leadership to inform decision-making and project adjustments Collaborate with internal and external stakeholders, including system leads, data management team, clinical teams and vendors Contribute the strategic development of clinical technology initiatives and lead the implementation as the tech project manager Maintain technical knowledge of the clinical data systems (EDC, IRT, eCOA, CDR and Imaging) and understand how the capability contributes to the submission data flow and overall DSS technology strategy Mentor Clinical Data Strategy and Operations Associates Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards Act as the clinical data systems SME during regulatory inspections and internal quality audits