Spectrum Pharmaceuticals, Inc.
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Associate Director Clinical Database Systems and Reporting
at Spectrum Pharmaceuticals, Inc.
The incumbant has responsibilities to ensure clinical databases are developed, validated and tested as per specifications and to support data reporting from clinical trials.
- 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.