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.
eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate , throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate - enabling our life sciences clients to proactively manage their clinical programs and make decisions.
You will make an impact:
The External Data Specialist is responsible for the processing of external and/or local lab data received at eClinical Solutions throughout the clinical trial lifecycle. The External Data Specialist works to ensure departmental SOPs, guidelines and global standards are followed to maintain data integrity and ensure consistency across all assigned projects. The External Data Specialist will assist the Clinical Data Management team with local lab and/or external data documentation review and quality control for trial deliverables .
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.
Your day to day:
In addition to the duties outlined, performs additional duties and responsibilities based on developing skills and capabilities:
Communicate to Clinical Data Manager, study team, and/or Manager, External Data problems involving local lab and/or vendor 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 external data reconciliation logs and/or change logs
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 accurately documented
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 local lab and external vendor associated study start-up and build activities
Perform IST activities for local lab normal range population
Develop the local lab and external data exception listing specifications and associated visualizations, and QC the output for movement to production
Provide support for set-up and implementation of external vendor data transfer agreements
Provide study specific local lab and/or external vendor data driven metrics to Clinical Data Management, Client and/or Project Management
Attend internal and external study team calls, as needed, for support of study specific local lab and external vendor data processes
Work closely with cross-functional teams on study reporting and data trending via clinical data…