Ref #: 28340

Employment type: Permanent - Full-Time

Location: Poland (HB)

Posted: 09-Apr-2021


• At least two years of experience as in-house CRA, CRA, Project Specialist, Data Management Professional
•Willingness to monitor key operational site/country/global level study parameters from a high-level office position
•Ability to see outliers as well as trends when analyzing data
•Experience in reacting/escalating in complex environment
•Very good understanding of clinical operations including site level processes
•Communication skills allowing smooth and effective interaction, including managing multiple communication streams
•Ability to proactively use systems and databases (CTMS, Rave, Spotfire)
•Solid clinical trials experience in pharma or CRO
•Knowledge of ICH-GCP and overall drug development processes.

•The Specialist manages and executes global Analytical Risk-Based Monitoring (ARBM) activities for allocated clinical trials in accordance with standard operating procedures, all relevant laws, regulations, guidelines, policies and good clinical practices.

•ARBM study related tasks and processes such as assessing protocols, finding risks, creating risk management and monitoring plans. Executing these plans and centrally monitoring the ongoing studies in collaboration with study teams
•Participating in Central Monitoring Working Group (CMWG) that works and decides on study related risks/trends and relevant actions/processes
•Identifying potential issues and findings requiring further review and follow up as part of CMM work and ensures appropriate actions are taken by the global/local teams members to investigate, resolve and document potential risks identified via data review, including ensuring adequate documentation of resolution
•Following up the resolution of issues found
•Providing input into lessons learned activities related to ARBM.
•Contributing to the ongoing development of the ARBM model of clinical trial management and related processes.
•Perform other work-related duties as assigned.