Clinical Data Laboratory Specialist
Syneos Health
Liber, del, Avda, BuenosAires, ARG, Argentina
hace 4 días

JOB SUMMARY

This position is responsible for the collection, validation and application of local clinical laboratory range data collected in global clinical trials to enable safety and medical data review and to enable accurate laboratory data analysis and reporting.

JOB RESPONSIBILITIES

  • Review of the central LNR database to assess the availability of the local laboratories being used on a project. Communicate with the project team to obtain LNRs not available in the central LNR database.
  • Transcription of the raw local lab range information provided by the site monitor into the LNR database (if not available)
  • QC of the LNR data entered into the central LNR database
  • Provision of the protocol-specific LNR output for each relevant site for entry into EDC
  • Raise queries regarding local laboratory range data to the local laboratory staff in order to resolve issues
  • Undertake QC of the local laboratory normal range data output, prior to entry into EDC
  • Liaise with the Clinical Data Management team regarding the provision of the project-specific local laboratory range data
  • Input data into the Clinical Laboratory Data tracking database and ensure accuracy of information
  • Provision of metrics to project teams regarding the status of project local laboratory range data to ensure timely collection and validation of data
  • Resolution of local lab ranges / unit conversion issues with Biostatistics and Medic as required
  • May support entry of the site-specific local laboratory normal ranges into EDC
  • May undertake QC of the entry of the site-specific local laboratory normal ranges into EDC by DM
  • Participates in internal audits as required
  • May provide clinical laboratory training to CDLS and project team members
  • Serves as a clinical laboratory data Subject Matter Expert (SME)
  • Qualifications

  • BA / BS in the biological sciences or related disciplines in the natural science / health care field or Registered Nurse.
  • B.Tech or N.Dip Biomedical Technology preferred where applicable in lieu of degree, equivalent relevant work experience

  • Clinical Data Management experience with particular experience of handling local laboratory data
  • Experience with local laboratory data collection methods and management of local laboratory range data in clinical trials
  • Understanding of laboratory analytes, their unit of measurement and associated normal and abnormal ranges for overall safety management of patients in clinical trials
  • Knowledge of medical terminology
  • Contract Research Organization (CRO) experience preferred
  • Good communication skills
  • Good organizational, planning, and time management skills preferred. Ability to multitask under tight deadlines while providing attention to detail
  • Able to demonstrate critical thinking with strong attention to detail
  • Knowledge of ICH / GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management and local laboratory data management
  • Ability to deal effectively with internal customers
  • Responsible for performing activities that are in compliance with applicable Corporate Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management.

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