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.
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)
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.