Senior External Data Specialist, remote Canada

Job Overview: May support Lead Data Manager (LDM) with the review, maintenance, and update of external vendor data received from central vendor or local laboratories. Working to ensure company SOPs (or sponsor, if applicable), guidelines and global standards are followed to maintain data integrity and ensure consistency across all projects. Summary of Responsibilities: Develop the Vendor Data Plan (VDP), including the Data Quality Review reconciliation section, or sponsor equivalent, for the external vendor data transfer(s), obtain final approvals and file document to the Trial Master File (TMF) as applicable. Collaborate with external vendor and sponsor counterparts for study expectations including milestones, deliverable timelines, communication expectations, etc. Ensure electronic external vendor data transfers contain all protocol specified parameters, is in correct format, and data populates to the specified fields and subjects correctly as designated in the Vendor Data Plan (VDP) or sponsor equivalent. Develop and document external data edit checks and reports in the edit check template or sponsor equivalent, obtain approvals and perform QC/UAT to verify the checks and reports are functioning properly. Review external data discrepancies generated by edit checks and reports and perform subsequent query management to resolve data issues. Maintain appropriate documentation of data issues in both study and vendor logs and follow outcome to resolution. May assist with review