Posted in: Executive Management in Chicago | Posted: |
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.