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Clinical Data Manager

Date Posted: 7/11/2019

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Job Description

A global Medical Device Company in Irvine, CA is looking to identify and hire a ?Clinical Data Manager who will translate Clinical study business requirements into system requirements for the collection and management of data from Clinical trials. The Clinical Data Manager will ensure the quality and integrity of data collected in Clinical studies, the privacy of patient data and efficient recording and reporting of safety related issues.

Job Duties:

  • Essential Job Functions- % of Time:
  • Create moderately complex metrics to identify trends in data and remediation, utilizing tools (e.g., systems, reports) to assess need for training and provide basic recommendations to improve data status during study conduct - 25%
  • Evaluate data errors and collection issues; provide guidance and recommendations to clinical team for resolution - 20%
  • Define and specify clinically data collection requirements (e.g., eCRFs, CRFs, edit checks and collection of external data) for assigned studies; including defining, performing, and coordinating user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected. - 15%
  • Lead project management activities for a cohort or project to bring clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders. - 15%
  • Maintain and develop assigned sections of Data Management deliverables including data management plans (DMPs), training materials and user aids in compliance with regulations - 10%
  • Perform Site/User Administration to allow access to the database, ensuring all users are qualified to access data base - 5%
  • Participate in development and review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, participating in the development of user training. - 5%
  • Other duties as assigned by leadership - 5%
  • Works independently without close supervision
  • Compares and evaluates possible courses of action after considering various possibilities
  • Applies his or her knowledge in following procedures or in determining which procedures to follow or determining whether specified standards are met
  • Considers the cause and effect of activities
  • Determines or effectively recommends course of action after considering potential risks of alternatives
  • May provide guidance to lower level personnel
  • Makes decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive, and which allow room for creativity and judgment
  • Direction tends to be high level and focused on end results with means of accomplishment left to incumbent
Skills & Qualifications:
  • Bachelor's Degree and experience with EDC (Electronic Data Capture) systems required
  • 3 Years of previous related experience in clinical research including clinical data management and/or clinical data entry required, 5 Years of previous experience preferred 
  • Solid knowledge of protocols, DMPs, and SAPs
  • Solid knowledge of processes and procedures in clinical data management
  • Solid knowledge and understanding of policies, procedures and guidelines relevant to clinical research
  • Good computer skills in Microsoft Office Suite
  • Good written and verbal communication skills and interpersonal relationship skills
  • Good problem-solving and critical thinking skills
  • Ability to manage competing priorities in a fast paced environment
  • Strict attention to detail
  • Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
  • Ability to build productive internal/external working relationships
  • Adh

Job Requirements

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Job Snapshot

  • Employee Type:Full-Time
  • Location:Irvine, CA
  • Job Type:Biotech, Research, Science
  • Experience:Not Specified
  • Education:Not Specified
  • Date Posted:7/11/2019
  • Contact: Sun Sa (949) 265-6070
  • Pay Range: $35.00 - $41.00 Hourly
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Job Reference: JO-1907-64265