Job Description

Essential Job Duties:
Sr. External Data Reviewer:

• Ensure electronic vendor data contains all protocol specified parameters, is in correct format and data populates to the specified fields and patients correctly
• May support LDM in the development of the Data Transfer Agreement and Data Transfer Specifications for vendor data transfers.
• Review data discrepancies generated by study specific edit checks for External data and perform the subsequent query management process in resolving the data issues.
• May support LDM to perform validation review of the electronically transmitted data for a sample of total number of patients in the study for loading purposes.
• Assist with review of External Data edit checks, External Data status reports and External Data listings across multiple protocols and vendor data
• Lead the External Data Review team and mentor new team members
• Interact with Clinical staff (CTM/CRA) to obtain local laboratory normal ranges for all sites. Research and resolve discrepant information concerning the normal ranges and maintain proper documentation.
• Enter and perform QC for local laboratory normal ranges. Verify the normal ranges are properly attached to the patient results in the local lab data collection module of the database.
• May support LDM to communicate to vendors and client problems involving data transfers, data point issues and validation issues with initial oversite for support of this communication from EDS Lead or above
• Perform other duties as required by the Department

Associate EDS Lead:

• Support development of 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.
• May participate in review of external vendor Statement of Work (SOW) for study scope, and ensure all protocol specified parameters are present as applicable.

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.

• Assist with development and documentation of 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.
• Assist with review of 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 of draft protocols from an external data perspective and assist with review of eCRF design per protocol parameters.
• Work with other study team functions to gather feedback and address any issues that could impact data review or analysis.
• May work with clinical staff to obtain and QC local laboratory ranges and verify the normal ranges are properly attached to the subject results in the local lab data.
• Participate in study team and department meetings as applicable.
• Effectively plan and support multiple high quality external data management projects simultaneously and provide updates to line management or other relevant stakeholders as requested.
• Complete Covance and sponsor (if applicable) trainings in a timely manner and perform job functions in accordance with set guidelines.
• Perform other duties as required by the department.

Labcorp is proud to be an Equal Opportunity Employer: As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply. For more information about how we collect and store your personal data, please see our Privacy Statement.