at AbbVie US LLC in North Chicago, Illinois, United States
Job Description
Senior Manager, EDC Systems Design, AbbVie Inc., North Chicago, IL. Responsible for ensuring successful delivery against programs & maintaining best in industry resources. Manage multiple technology evaluations & implementations for performance improvement & cost reduction by practicing continuous improvement of processes & technology usage. Provide strategic input on the analysis of new computerized systems & software used for clinical trial data collection, quality assurance and integrity. Define, complete, validate, apply and oversee electronic case report form (ECRF) systems, external data acquisitions, reporting & business intelligence tools including Spotfire, J-Review, SQL, PL-SQL, & SAS. Supervise & allocate internal & external resources within the Therapeutic Area. Ensure all performance assessment responsibilities are achieved for direct reports by providing training & feedback, resolve personnel issues, and manage talent retention for assigned staff. Apply data capture systems and methods as a member of the CRF Review team & complete reports of use in data review & reconciliation. Responsible for the performance management of staff. Support team in building & maintaining a high performing team, recruitment, onboarding, resource assignment, & development opportunities for staff within responsibility. Complete the validation of electronic systems, software & programs applied internally per current regulatory requirements such as 21 CFR Part 11 & ICH- GCP. Provide strategic direction, advice & guidance to staff in relation to operations responsibilities & activities by promoting best practice & ensure that objectives are successfully met. Manage data capture, review and database lock activities for programming activities from start-up through statistical analysis stage of clinical studies. Lead the application of programming standards & conventions. Responsible for selecting & managing vendors including CROS, FSP & technology providers. Employ experience with clinical database design, data loading, & database modeling concepts such as SAS, SQL, CDASH, SDTM, Medidata RAVE, Python, & Veeva EDC. Up to 10% domestic & international travel required. Must possess a Bachelor’s degree or foreign academic equivalent in Computer Science, Information Technology, Electronic Engineering or other technical field plus 5 years of related work experience in clinical research, project management, or similar industrial background. Must possess experience in the following: (i) defining, completing, validating, applying and overseeing electronic case report form (ECRF) systems, external data acquisitions, reporting & business intelligence tools including Spotfire, J-Review, SQL, PL-SQL, and SAS; (ii) completing the validation of electronic systems, software and programs applied internally per current regulatory requirements such as 21 CFR Part 11 & ICH- GCP; (iii) managing data capture, review and database lock activities for programming activities from start-up through statistical analysis stage of clinical studies; & (iv) clinical database design, data loading, & database modeling concepts such as SAS, SQL, CDASH, SDTM, Medidata RAVE, Python & Veeva EDC. Up to 10% domestic & international travel required. Position requires work at various & unanticipated work locations throughout the U.S. 100% telecommuting is permissible. Salary Range: $163,360 - $223,500 per year Apply online at https://careers.abbvie.com/en. Refer to Req ID: REF24398B.
