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Associate central monitor - data surveillance, clinical data sciences - fsp

Xico, Ver
Parexel
Monitor
Publicada el 1 mayo
Descripción

*job summary*role responsibilities*general:- assist the manager implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.- assist to set up and test study level risk-based monitoring analytics system using sas/sql/r/python- help execute communication plans & methods to meet study requirement.- assist to resolve conflicts, influence and communicate with key stakeholders and customers.system setup functions:- set up and test rbm analytics system at study level to ensure system quality.- define key risk indicators (kris) in study system, and ensure consistency between the standard level and the study level.- ensure rbm analytics system align with the protocol and adhere to ich gcp, sops, corporate standards and regulatory requirements.data review functions:- implement and maintain quality control related documentations for rbm related activities to ensure data completeness and accuracy.- assist central monitoring activities including review system outputs, signal and action management.*basic qualifications*:- bachelor's degree or above of equivalent experience in a scientific or business related discipline required.- works independently, receives instruction primarily on unusual situations- ability to organize tasks, time and priorities; ability to multi-task- ability to communicate with internal & external stakeholders, locally and globallypreferred qualifications:- working knowledge of clinical development process, understanding concepts of phase i-iv and principles of study design- technical expertise in supporting clinical trials database development, data management, site monitoring, etc.- previous experience within a data management role, understanding key processes and principles associated with role including crf design, database set-up, edit check specification, dmps and data cleaning activities- familiar with the processes associated with clinical study management, data management, and regulatory operations.- experience in oracle, pl/sql, sas, java, relational database design and database programming skills.li-remote

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Inicio > Empleo > Empleo Educación > Empleo Monitor > Empleo Monitor en Xico, Ver > Associate central monitor - data surveillance, clinical data sciences - fsp

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