职位描述

Primary ResponsibilitiesGeneral?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?Plan and execute communication plans & methods to ensure customer satisfaction and enable improvements to be implemented during the course of a study.?Able to resolve conflicts, influence and communicate with key stakeholders and customers.System setup Functions:?Review protocols to ensure the set-up, review and reporting requirements can be met and are standardized.?Provide technical oversight, guidance and coordination for all the central monitor activities.?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.?Set up dictionary for data quality assessment DQA in study system?Ensure RBM system align with the protocol and adhere to ICH GCP, SOPs, corporate standards and regulatory requirements.Data review Functions:?Work with Study Team to define the issue resolution for the reviewing findings as signal and action.?Develop, 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.?Ensure lessons learnt during the course of the study are documented and shared with other central monitors/ study teams to facilitate cross-study learning.Organizational relationships and interfaces:?The single point of contact for study team on central monitor activities.?Accountable for the implementation of all central monitor activities for the responsible studies.?Interact with Clinical Data Scientist (CDMM) at study level for deliverables.?Interact with other study team members at study level for deliverables.Technical Skill Requirements?Technical expertise and business experience in supporting clinical trials database development, data management, site monitoring, etc.?Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations.?Project management skills and technical capabilities as well as 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 effectively and appropriately with internal & external stakeholders, locally and globally?Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.Qualifications (i.e., preferred education, experience, attributes)? Bachelor’s degree or above of equivalent experience in a scientific or business related discipline required.Preferred Additional Experience?Minimum 5 years working experience in the clinical development fields.?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. 职能类别： 医药技术研发管理人员 药品生产/质量管理

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