Spectrum Pharmaceuticals, Inc.

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Associate Director Clinical Database Systems and Reporting

at Spectrum Pharmaceuticals, Inc.

Posted: 10/2/2019
Job Reference #: 643
Keywords: system

Job Description

Tracking Code
643-470
Job Description

Summary:

The incumbant has responsibilities to ensure clinical databases are developed, validated and tested as per specifications and to support data reporting from clinical trials.

Responsibilities:

  • Work closely with the cross-functional team of data managers,clinical operations,medicalmonitors, biostatisticians to collect study and user specifications to design and develop databases for clinical studies.
  • Design and develop databases for clinical trials including validation checks and reporting programming using the sponsor selected electronic data capture systems
  • Conduct database validations and user acceptance tests for the studies assigned using the selected database systems
  • Support production of customized data displays,(including patient profiles, data reports,metrics reports using graphicalinterface) in accordance with approved clinical study protocols and statistical analysis plans for clinical research studies.
  • Perform external data loads,i.e.,labs, ECGs, etc., as needed and run efficient reconciliations

Skills, Education and Experience:

  • BA/BS degree preferred and/or experience 4-8 years of experience in a related field
  • Strong relational database and other clinical database development experience especially in commonly used electronic data capture (EDC) systems for clinicaltrials
  • Experience in supporting data reporting activities including gathering and compiling user requirement, development of report specification and development of automated, standardized and ad hoc reports.
  • Previous report generation skills using reporting software (ie. Spotfire)
  • Strong SAS system experience both in statistical analysis and database development
  • Strong planning,organizational, and problem solving and communication skills
  • Must have a high degree of initiative and ability to collaborate with several departments
  • knowledge of CDISC/CDASH and basic understanding of SAS
  • Knowledge of Python or other shell programming language is a plus
  • Knowledge of good documentation practice

Position location and/or Territory and Travel

  • Position is located in Irvine, CA.
  • No project related travel expected.

Job Location
Irvine, CA or Boston, MA, United States
Position Type
Full-Time/Regular