Associate Central Monitor

1 semana atrás

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 globally
PREFERRED 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.
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