ROLE SUMMARY

The Central Monitor is responsible for ensuring the completeness, quality and integrity of the subject data in the clinical trial database under Risk Based Monitoring (RBM) mode. The areas of activity include but are not limited to: developing Risk-Based Monitoring system for applicable studies, ensuring key risk indicators (KRIs) properly defined and set up in the system to support the study, processing and reviewing study data in the system for the signal and action management, follow up for the issue resolution. The Central Monitor ensures risk based monitoring activities comply with regulations, applicable Standard Operating Procedures (SOPs) and Processes at all times and is familiar with supported systems (RBM system, etc.) and able to troubleshoot and provide rapid response for all database issues. The Central Monitor works with the global study team to meet the study objectives.

ROLE RESPONSIBILITIES

General:

• Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.

• Provide technical expertise to set up and test study level Risk-based Monitoring system

• Review study level system outputs to process for the signal and action management

• Execute communication plans & methods to ensure customer satisfaction and enable improvements to be implemented during the course of a study.

• Provide technical support to resolve conflicts, influence and communicate with key stakeholders and customers.

System setup Functions:

• Set up and test RBM 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 system align with the protocol and adhere to ICH GCP, SOPs, corporate standards and regulatory requirements.

Data review Functions:

• Provide technical support to define the issue resolution for the reviewing findings as signal and action.

• Implement and maintain Quality Control related documentations for RBM related activities to ensure data completeness and accuracy.

• Perform central monitoring activities including review system outputs, propose suggestion for signal and action management, and follow up with study team for the action resolution.

• Work with Clinical Data Scientist (CDS) to ensure all signal and actions are properly mitigated and RBM systems properly released.

BASIC QUALIFICATIONS:

• Bachelor’s degree or above of equivalent experience in a scientific or business related discipline required.

• Minimum 3+ years of experience related to clinical trial (CRA, DM, Programmer, etc.)

• Technical expertise in supporting clinical trials database development, data management, site monitoring, etc.

• Familiar with the processes associated with clinical study management, data management, and regulatory operations.

• Technical capabilities, effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.

• 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

• 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

• Knowledge of clinical trial database and its applications

• Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.)

• Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills.

Work Location Assignment:Hybrid

Please apply by sending your CV and a motivational letter in English