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Senior Clinical Data Manager

Company: ClinDatrix, Inc.
Location: Irvine
Posted on: April 5, 2021

Job Description:

The Experience of Big. The Advantage of Value. You are here: Home / Careers / Senior Clinical Data Manager ClinDatrix is looking to hire a full time in-house--Senior Clinical Data Manager. The ideal candidate should be located in Southern CA and work in the ClinDatrix office. ClinDatrix is a small service provider, CRO, located in Irvine, CA dedicated to clinical research, data management, and statistical analyses and reporting servicing the biotechnology, medical device, and pharmaceutical industries. Responsibilities

  • Review Case Report Form (CRF) data for completeness, accuracy, plausibility, clinical correctness, and logical consistency.
  • Identify data discrepancies in the CRF data via computerized edits, manual data checks, and tables and listings.
  • Develop, validate, implement, run and maintain edit check programs to assist with the review and management of clinical data.
  • Generate Data Clarification Forms (DCFs) and work with Clinical Research Associates (CRAs) and investigator sites to resolve data issues.
  • Perform additional data review activities as required to provide clean data for the purposes of analysis.
  • Update/correct data in the clinical databases based on the resolved DCFs.
  • Code Adverse Events and Medications using MedDRA, WHO Drug or other standard dictionaries.
  • Reconcile Adverse Event data reported on CRFs with Serious Adverse Event data reports or listings.
  • Design, validate, implement and maintain clinical trial databases.
  • Design and generate study specific Case Report Forms (CRFs) to ensure that data required by the protocol are accurately captured on the CRF.
  • Assist with the development and maintenance of Case Report Form standards.
  • Develop CRF Instruction Manuals to guide study investigators and site personnel in completing the CRF.
  • Develop and maintain project-specific Data Management Plans based upon the protocol, statistical analysis plan, clinical monitoring plan and CRF to ensure that data collected during clinical trials are reviewed and managed to a level appropriate to allow for planned analyses and meet regulatory requirements for data quality.
  • Develop protocol-specific Data Review Guides to facilitate the review of clinical data.
  • Program and generate listings, tables and graphical displays.
  • Maintain complete and auditable documentation of all data management project activities.
  • Develop and generate project status reports for management.
  • Coordinate data management projects and staff on all clinical trial projects in which clinical data management is performed at ClinDatrix.
  • Assist with the development, review and modification of departmental Standard Operating Procedures (SOPs).
  • Assist with training and mentoring of less experienced staff.
  • Perform other general duties as required to support the company. Qualifications and Requirements
    • Bachelor's degree or the equivalent in a scientific discipline
    • Three to five years clinical data management experience, including database set up, edit check programming, patient data review and database finalization activities
    • One or two years of a leadership role on a data management project
    • Knowledge of database technologies and processes
    • Familiarity with FDA regulations respecting data quality and clinical trials conduct
    • Strong written and oral communication skills; excellent interpersonal skills
    • Ability to work productively and efficiently within a team environment
    • Ability to manage competing priorities in a changeable environment
    • Ability to handle stressful situations and deadlines To start the conversation, please write, fax or click--here . Primary Sidebar Contact Us Take advantage of our value and experience.
      ClinDatrix, Inc. * 1 Ada, Suite 250 * Irvine, CA 92618 * Tel: 949.428.6600 * Fax: 949.428.1239

Keywords: ClinDatrix, Inc., Irvine , Senior Clinical Data Manager, Healthcare , Irvine, California

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