Associate Central Monitor - Data Surveillance, Clinical Data Sciences - FSP

JOB SUMMARY

The Associate Central Monitor is supporting the completeness, quality and integrity of the subject data in the clinical trial database under Risk Based Monitoring (RBM) model. The areas of activity include but are not limited to: developing Risk-Based Monitoring analytics system for applicable studies, ensuring key risk indicators (KRIs) properly defined and set up in the system to support the study. The Associate Central Monitor supports risk based monitoring activities and complies with regulations, applicable Standard Operating Procedures (SOPs) and Processes at all times and is familiar with supported systems (RBM system, etc.). The Associate Central Monitor works with Senior Central Monitor to meet the study objectives.

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.

• 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.