Job Abstract

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 a key to ensuring successful Data collection systems delivery against the program and study-level accountabilities.

Description:

Provides technical project management leadership, support, and influence to ensure timely and quality clinical technology deliverables across data collection and processing systems such as Electronic Data Capture (EDC), Interactive Response Technology (IRT), Electronic Clinical Outcome Assessment (eCOA) , Clinical Photography/Imaging, Clinical Data Repository (CDR).

• Leads and manages the full lifecycle of systems developed internally or by the external vendors for individual clinical trial use.
• Managing the design, development, validation, implementation, and overseeing ongoing support to these systems.
• Support in the validation of electronic clinical technology systems as implemented throughexternal vendors or developed internally according to current regulatory requirements.
• Supports development and implementation of departmental Standard Operating Procedures (SOPs) and work practices.
• Provides leadership and content expertise for system development activities from start-up through the statistical analysis stage of clinical studies to effectively manage data capture, review, and database lock activities.
• Other responsibilities include providing strategic input into the analysis of new systems and software to support clinical trials data collection, quality, and integrity.
• Support inspection readiness activities, as well as participate in sponsor and site inspections.
• Responsible for hiring, training, and managing performance of staff (inclusive of orientation, personal development, completing and administering performance evaluations, reward and recognition). Ensures timely hiring of qualified resources. Actively promoting empowerment and accountability within staff.

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required