Safety Data Coordinator 2


Safety Data Coordinator 2

  • Job Locations(All) | US-Remote
  • ID: 2020-71253

Overview

Leads the development and implementation of medical coding in clinical data management systems; participates in management of individual case safety reports (SAEs, AEs of Special Interest, Adverse Drug Reactions), AE/SAE reconciliation and data retrievals from the clinical and/or safety databases; provides support for endpoint adjudication committees.

Responsibilities

  • Performs consistent coding of adverse events, medical history, concomitant medications and other terms according to the project-specific coding conventions.
  • Reconciles SAE/AE between clinical and safety database in accordance with the SAE/AE reconciliation plan and other project-specific guidelines.
  • Generates DCFs (Data Clarification Forms) or queries, performs corrections of CRFs, if applicable, and clinical databases in accordance with DCF replies.
  • Receives and tracks serious adverse events, adverse events of special interest, and adverse drug reactions reports and forwards them to the sponsor/third party in accordance with project-specific contractual agreement.
  • Performs data entry of minimal SAE/ADR data in company’s or sponsor’s safety database.
  • Queries site or reporter for inconsistent or incomplete information on SAE/ADR report.
  • Maintains address lists for submission of safety reports to investigators and EC/IRBs.
  • Tracks submission of safety reports to investigators and EC/IRBs in company’s Safety Letter Tracking System.
  • Conducts quality review of endpoint dossiers/adjudication forms adhering to the agreed timelines.
  • Tracks and reconciles endpoint dossiers/adjudication forms.
  • Queries sites for missing or inconsistent information on endpoint dossiers/adjudication forms.
  • Interacts with endpoint committee during endpoint review.
  • Properly documents all internal and external contacts and communications.
  • Consistently meets or exceeds objectives set annually.
  • Ensures personal career goals are set each year and progress is monitored for completion
  • Performs consistent coding of adverse events, medical history, concomitant medications and other terms according to the project-specific coding conventions.
  • Reconciles SAE/AE between clinical and safety database in accordance with the SAE/AE reconciliation plan and other project-specific guidelines.
  • Generates DCFs (Data Clarification Forms) or queries, performs corrections of CRFs, if applicable, and clinical databases in accordance with DCF replies.
  • Receives and tracks serious adverse events, adverse events of special interest, and adverse drug reactions reports and forwards them to the sponsor/third party in accordance with project-specific contractual agreement.
  • Performs data entry of minimal SAE/ADR data in company’s or sponsor’s safety database.
  • Queries site or reporter for inconsistent or incomplete information on SAE/ADR report.
  • Maintains address lists for submission of safety reports to investigators and EC/IRBs.
  • Tracks submission of safety reports to investigators and EC/IRBs in company’s Safety Letter Tracking System.
  • Conducts quality review of endpoint dossiers/adjudication forms adhering to the agreed timelines.
  • Tracks and reconciles endpoint dossiers/adjudication forms.
  • Queries sites for missing or inconsistent information on endpoint dossiers/adjudication forms.
  • Interacts with endpoint committee during endpoint review.
  • Properly documents all internal and external contacts and communications.Consistently meets or exceeds objectives set annually.
  • Ensures personal career goals are set each year and progress is monitored for completion.
  • Responsible for effective and efficient development of the coding conventions and coding dictionary license confirmation forms.
  • Manages quality control review of coded data.
  • Responsible for effective and efficient development of the SAE/AE reconciliation plan.
  • Performs quality control of minimal data entry of safety data into company’s or sponsor’s safety database.
  • Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately.
  • Participates in internal and client meetings.
  • Reports project status to project/functional management.
  • Adheres to financial and administrative processes, such as managing project budget and timelines, estimation of resource needs and projected hours.

Qualifications

  • Undergraduate degree or its international equivalent, preferably in life science and/or healthcare professional.
  • Read, write and speak English; fluent in host country language required.
  • Previous experience using computerized information systems and standard application software (Windows, MS Office).
  • Good written and oral communication skills.
  • 3 Years Data Management or Health information Management experience required


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PRA Health Sciences

PRA
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