Senior Manager, EDC Systems Design

2 months ago


North Chicago Illinois, United States AbbVie Full time
Job Description

Key Responsibilities

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.

 


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