Jr. Clinical data manager - Jobs in Bedminster Township, NJ - 354366

Job Summary
  • Skills CDM, CDISC, CRF, DMP
  • Job Type
    Full Time
  • Salary
    Depends on Experience
  • Telecommuting
    Work from home available Travel not required

Job Description

Create and review (electronic) Case Report Forms per Protocol and annotated Case Report Forms Review Protocols to ensure database feasibility Develop/build, review, and maintain a clinical database and supporting specifications documentation Develop/build, document and perform validation of database structure, data capture screens, code lists, edit checks, reports and other functions in EDC (e.g. User Acceptance Testing) Develop data transfer agreements and specifications with various vendors Write, review and maintain eCRF completion guidelines, data management plan (DMP), data validation plan (DVP, e.g. edit checks), and other DM related documentation Perform all aspects of DM process as related to processing and QC of the data Clean data for study close out and perform all database lock procedures Manage reconciliation with any external data (e.g. SAE, lab) Monitor study status (e.g. enrollment, CRFs, etc.) and provide status reports to the team Use standard conventions, tools, references and process in support of the coding of medical terms Ensures all DM procedures executed with a high attention to detail, accuracy and timelines Represent the DM function on project teams Write and review DM SOPs in accordance with GCP and ICH guidelines, and develop associated training and competency testing Maintain CRFs m1d database standards Work in conjunction with Clinical Operations, Clinical Research, and other operations to ensure accurate, efficient, and complete data collection Mentor junior level staff on database management tasks and processes Contribute/participate in data management initiatives Other duties as assignedEducation : B.S. in Mathematics/Statistics, Computer Science, Life Sciences or related field
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