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- Clinical Data Analyst
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Clinical Data Analyst
Parexel International Corporation
China
Experience:
· Typically 2-3 years of experience in Pharmaceutical or Biotech Clinical Data Management (CDM)
· Preferably 2-3 years in processing of lab data for clinical trials
· Minimum 2 years’ experience in managing study level projects
· Very good attention to detail and accuracy
· General working knowledge of medical terminology
Knowledge:
· Clinical Trial Databases and Applications
· Good Clinical Practice (GCP) / International Conference on Harmonization (ICH)
· Drug Development Process
· Scientific and technical knowledge of lab data processing for clinical trials and how they apply to review of clinical data.
· Medical / life science in several therapeutic areas
Key Activities:
· Protocol Review for lab requirements
· Review of ALS, DARS, DMP, eCRF Completion Guidelines and coordinates with the Lead Data Manager for all discrepancies found
· New Lab Parameter/New Unit/Textbook Ranges Approval Process
· Review of source document and preparing the LTQ for LNR entry.
· SAS Checks review
· Lab data review (Lab view via J-review) – monthly
· Lab Form query resolution (system to site, system to LDR, LDR to site) on daily basis.
· Resolve and issue queries on the lab data to ensure the lab data is clean.
Interaction with other LDR’s to verify/clarify information on new data issues.
QualificationsExperience:
· Typically 2-3 years of experience in Pharmaceutical or Biotech Clinical Data Management (CDM)
· Preferably 2-3 years in processing of lab data for clinical trials
· Minimum 2 years’ experience in managing study level projects
· Very good attention to detail and accuracy
· General working knowledge of medical terminology
Knowledge:
· Clinical Trial Databases and Applications
· Good Clinical Practice (GCP) / International Conference on Harmonization (ICH)
· Drug Development Process
· Scientific and technical knowledge of lab data processing for clinical trials and how they apply to review of clinical data.
· Medical / life science in several therapeutic areas
Key Activities:
· Protocol Review for lab requirements
· Review of ALS, DARS, DMP, eCRF Completion Guidelines and coordinates with the Lead Data Manager for all discrepancies found
· New Lab Parameter/New Unit/Textbook Ranges Approval Process
· Review of source document and preparing the LTQ for LNR entry.
· SAS Checks review
· Lab data review (Lab view via J-review) – monthly
· Lab Form query resolution (system to site, system to LDR, LDR to site) on daily basis.
· Resolve and issue queries on the lab data to ensure the lab data is clean.
Interaction with other LDR’s to verify/clarify information on new data issues.
Job posted: 2020-12-19