Clinical Data Manager I
HYBRID GRAYSLAKE IL 4 days onsite Pay: $40-$43/hr REQUIRED: BS in science discipline Must have at least 4+ years of pharmaceutical, clinical research, data management, health care or other relevant experienceMust have: Some type of EDC - ClinSpark is what they use (this can be trained – this is their EDC) - RAVE is a good substitute Previous CRO / sponsor experience Data cleaning Manage queries Interacted with vendorsStrong understanding of clinical trial processes and clinical technologyDemonstrated history of successful execution in a fast-paced environment and in managing multiple priorities effectivelyStrong understanding of GCDMPJob Description: The Data Manager is a member of the Data Management and Analysis team responsible for supporting the successful delivery of data and processes conducted by CROs. This individual will collaborate closely with the Data Management & Analysis team and internal colleagues to ensure data integrity and quality in human clinical trials up through clinical proof of concept.Responsibilities:Provide CRO oversight and feedback related to the data management operations, issues and trends in performanceCompletes assignments as delegated by Data Management relating to operational objectives and study deliverablesEffectively utilizes available technology, EDC platforms, Reporting and Visualization toolsReviews CRO deliverable to ensure adherence to data standards and protocol requirements implemented within the designReviews study execution documents including specifications, data management plan, data review plan, data transfer plan and other cross functional plans delineating data review needsProvide CRO oversight of data management tasks in adherence with established standards including third party vendor data reconciliation, medical coding processing, protocol deviation collection, and query management to identify errors and inconsistencies in clinical data and ensure their resolutionIdentify and triage issues as they occurEnsures CRO data management adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and to data management quality standards.