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Senior Manager, EDC Systems Design

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. 

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Job Posting: 11869338

Posted On: May 01, 2024

Updated On: Jun 07, 2024

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