Clinical Data Analyst

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.