工作职责:
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 (CDMM) to ensure all signal and actions are properly mitigated and RBM systems properly released.
任职资格:
BASIC QUALIFICATIONS:
? Bachelor’s degree or above of equivalent experience in a scientific or business related discipline required.
? 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
? Minimum 1 year experience related to clinical trial (CRA, DM, Programmer, etc.)
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.