Job Information
NEXPRO TECHNOLOGIES INC Clinical Data Manager in King Of Prussia, Pennsylvania
Serve as a contact representing DM within Biometrics and clinical study management teams (SMT and/or Clinical Development Team representatives).
Handle Clinical Data discrepancy management includes query management, data validation, data listings review using data analytical/ review tools such as J review, Spotfire & BOXI.
Review & approve of data capture tools EDC (Medidata Rave, Inform Oracle, CLIN quick),IRT/ePRO/eDairy tools to ensure data capture tool is validated by CRO prior to system deployment.
Develop Clinical Trial database in Electronic Data Capture (EDC) systems like Medidata Rave & Oracle inform; Program Edit checks (Multivariate, Univariate, & custom functions) with sequence query languages (SQL).
Maintain standard database structures, naming conventions, code lists concerning laboratory/ electronic data with SQL programming.
Manage data coordinators for system integration of Interactive Response Technology & RAVE to manage clinical data flow between different systems.
Serve as a contact representing DM within Biometrics and clinical study management teams.
Guide data management team in establishing link between different databases, prepare customized dashboards, and provide data visuals for analysis by conducting advanced mapping operations in Tableau.
handling clinical data on identifying types of analysis to be done during e study Descriptive statistics, chi-square test, survival plots, efficacy analyses, pharmacokinetic analyses, progression-free survival by building a Statistical Analysis Plan.
Oversee clinical data monitoring activities including setting & validation of Risk Indicators, Data Quality Assessments for studies on Centralized Monitoring Tools like Cluepoints & Medidata CSA.
Position Requirements: Master's degree or a foreign equivalent degree in Healthcare Informatics, Health Admin, Pharmacology, Toxicology, Pharmacy, Chemistry, Computer science, Bio Informatics, Bio Technology, Statistics or related field.
Special Skills: Position requires travel/relocation to various unanticipated client locations throughout the U.S. with expenses paid by the employer.
Benefits: Medical, Life Insurance and 401K.
Standard Company Benefits.