Sr External Data Specialist

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. OVERVIEW The Senior External Data Specialist is responsible for managing the processing of external and/or local lab data received at eClinical Solutions throughout the clinical trial lifecycle. The Senior External Data Specialist will provide subject matter expertise in external data handling of various external data sources (ie: central laboratories, imaging, PK, PD, eCOA, ePRO, etc.) to internal cross-functional teams and external stakeholders to ensure high quality data. The Senior External Data Specialist works to ensure departmental SOPs, guidelines, regulatory and global standards are followed to maintain data integrity and ensure consistency across all assigned projects. This position reports to the Manager, External Data. KEY TASKS & RESPONSIBILITIES In addition to the duties outlined, performs additional duties and responsibilities based on developing skills and capabilities: Act as primary study contact, subject matter expert (SME) and liaison for external data and local lab processing on assigned studies for internal and external stakeholders. Communicate to Clinical Data Manager, study team, and/or Manager, External Data problems involving local lab data point issues and validation issues. Communicate to vendors and client issues involving external data transfers, data point issues and validation issues. Perform QC of laboratory normal ranges prior to entry to ensure documents received are ICH/CGP compliant and accurate. Perform Lab Normal Range data entry and/or QC, meeting processing deliverables on time and with quality. Review study protocols and local lab and external data eCRF design in start-up, providing recommendations and insights into best approach for data aggregation and capture. Ensure clinical database supports data requirements and is in alignment with external vendor data. Perform QC of external data test transfers for acceptance. Maintain data transfer agreement set-up logs, reconciliation logs and/or change logs. Perform QC of laboratory normal ranges prior to entry to ensure documents received are ICH/CGP compliant and accurate. Verify the normal ranges are properly linked to the patient results in the local lab data collection module of the database. Review external vendor data and/or local laboratory data listings via elluminate® and issue queries or communicate data issues to internal and/or external team members. Review and provide input to DMP, IDROP and CCG to ensure local lab normal range and/or external data process for assigned study is…