Sr Clinical Data Laboratory Specialist - Argentina
Syneos Health
Liber, del, Avda, BuenosAires, ARG, Argentina
hace 6 días

JOB SUMMARY

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

They will oversee a team of Clinical Laboratory Data Specialists (CLDS) who will be assigned to support projects across all Therapeutic Area Business Units within Clinical Development.

JOB RESPONSIBILITIES

  • Maintains awareness of the pertinent elements of contract and scope of work for the Clinical Laboratory Data Specialist teams (CLDS)
  • In partnership with the CLDS management team, support assignment of the CLDS team and project management of the CLDS deliverables to ensure local laboratory data delivery across the global TA BU portfolio
  • Inputs to the development of training for the CDLS team
  • Undertake training and mentoring of the CLDS team on the Clinical Local Laboratory data processes
  • Oversee management and maintenance of the central LNR database and leads enhancements working with the Clinical Programming team on the implementation
  • Review of central LNR database to assess the availability of the local laboratories being used on a project. Requests sent to the project team for LNRs that will be required
  • Assessment and interpretation of the project protocol to develop the project-specific local laboratory normal range output from the LNR database for use in the project, including updates required from protocol amendments that impact local laboratory data
  • Provision of the project-specific LNR output to the project team members for review and approval.
  • Attendance at Trusted Process meetings related to local laboratory data collection and normal range management
  • Provision of the agreed project-specific local laboratory range output to the Lead Clinical Data Manager for filing in the TMF
  • Undertake QC of the CLDS team deliverables
  • Input tracking and status information into the Clinical Laboratory Data tracking database and ensure accuracy of information
  • Provision of metrics to project teams and executive leadership regarding the status of project local laboratory normal range data to ensure timely collection and validation of data
  • Escalation with project team and / or local laboratory staff in order to resolve issues
  • Resolution of local lab ranges / unit conversion issues with Biostatistics and Medic as applicable
  • 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
  • Oversee the management of the laboratory Standard International (SI) units library, working with the relevant Data Operations team members to maintain the SI library for application on projects
  • Provision of status reports to the project team
  • Develops and provides clinical laboratory training to team members
  • May act as Process owner for the local laboratory range procedures and templates
  • Serves as a clinical laboratory data Subject Matter Expert (SME)
  • Working with the management team, supports the implementation of new regulatory requirements related to local laboratory management
  • May be required to participate in client, internal or agency audits and inspections
  • 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
  • Strong project management skills and demonstrated staff leadership skills
  • Contract Research Organization (CRO) experience preferred
  • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
  • 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
  • Ability to be flexible and adapt to change. Ability to work independently as well as part of a multi-disciplinary team
  • Ability to make effective decisions and manage multiple priorities in a highly dynamic environment
  • 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 sponsors and 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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