Technical Analyst II, Informatics

Job Overview:

The Analyst II is an experienced member of the Xcellerate Monitoring Integration and Configuration Services (XMICS), part of Xcellerate Customer Success and global risk based monitoring team and has responsibility for execution of several key Risk Based Monitoring (RBM) data integration, standard and custom mapping and tool configuration and customization activities and operates as a Lead XMICS Analyst for assigned studies. The Analyst II collaborates with the study team to define configuration plans, map operational and clinical data, set up central monitoring tools and dashboards to comply with the central monitoring configuration plans. The Analyst II requires working knowledge of two or more areas of programming (e.g. clinical data structures and mapping, tool configuration and JSON, JavaScript or HTML5 programming) as well as a working knowledge of broader drug development and clinical trials. He/she is responsible for accurate and timely uploading of operational and clinical trial data and refresh of central monitoring dashboards and tools. He/she provides RBM tool expertise to the study team. He/she will lead Xcellerate Monitoring, RBM and central monitoring integration and configuration services for at least 1 clinical study.

 Lead XMICS Analyst for at least one study Tracking of Request For Proposal and Project/Studies running reports of RFPs Review New Award Notification Collect New Award study details Update Clinical Business Informatics Solutions & MDFO Project Trackers Review Standard Libraries for at least 2 XM Tools Assess study specific requirements Develop XRIM Configuration Plans for Xcellerate Monitoring tools including Xcellerate Risk Review (XRR), Medical Review (XMR), Statistical Review (XSR), Data Review (XDR) and Risk & Issue Management (XRIM) Develop export requirements Obtain Standard Data Sources and develop contacts with providers Obtain non-Standard Data Sources and develop contacts with providers Perform, Document & verify standard and custom study mapping to Operational Data Warehouse (ODW) Verify ODW study mapping Perform, Document & verify standard and custom study mapping to SDW Verify study mapping to SDW Perform, document & verify standard XRR, XMR, XSR and XDR study configuration Develop export programs in at least two of Xcellerate® Monitoring tools Perform XRR, XMR, XSR, XDR and XRIM study testing & support launch in production Develop Study Specific Data Source, Risk Indicator & Visualization Perform regular data loading into SDW Support resolution of helpdesk calls Perform, document and verify maintenance and update of Standards in Xcellerate Monitoring tools Produce and verify eTMF artefacts during study from Xcellerate Monitoring tools Perform exception review, error and performance analysis of SDW data loading Perform, document and verify client specific export Produce and verify final eTMF artefacts during study closure from Xcellerate Monitoring tools Perform dataset extraction for long term storage Education/Qualifications:Recommended:

University degree education preferred (if required or experience level which may be substituted for level of education) in science, mathematics or computer science.

Professional degree/designations/certifications/licenses legally required (i.e. RN, MD, VDM etc.).

  Experience:Minimum Required:

Minimum of three years relevant electronic data collection (EDC) design, clinical data management, statistical programming (using SAS or SQL) OR data science / informatics experience with increasing levels of responsibility.

Good understanding of algorithms and their scalability

Good programming skills in 2 of the following; SAS, C#, C++, R, Matlab or equivalent

Good understanding of relational databases and SQL

Preferred:

Two years’ experience in 2 of SAS, SQL, NoSQL, JSON, JavaScript and HTML5 programming and development experience.

No experience of risk management, risk based monitoring or central monitoring is required.