Associate Central Monitor

3 semanas atrás


Brasília, Brasil Parexel Tempo inteiro

**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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