Sr. Associate Central Monitor, Risk Based Monitoring, DMM

Role Summary

As part of the Data Monitoring and Management group, an integral delivery unit within the Global Product Development (GPD) organization, the Sr. Associate Central Monitor is a highly technical team member responsible for ensuring the completeness, quality and integrity of the subject data in the clinical trial database under Risk Based Monitoring (RBM) model. Activities typically include developing the Risk-Based Monitoring system (i.e. CluePoints) for applicable studies, ensuring key risk indicators (KRIs) and data quality assessment (DQA) 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,and follow up for the issue resolution.

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
• 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 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.

Qualifications

Must-Have

• Bachelor's Degree
• 3+ years' experience
• Demonstrated knowledge of clinical development including knowledge and understanding of the principles of GCP
• Awareness of relevant data standards, e.g. CDISC, CDASH, SDTM
• Experience with or ability to learn programming in a clinical trial environment, e.g. YAML script, SAS code, SQL query, R, Python, to extract and analyze operational and clinical trial data from various information systems
• Ability to critically analyze, interpret, and summarize statistical output from risk-based quality management software, e.g. CluePoints
• Ability to manage tasks, time and priorities
• Demonstrated effective verbal and written communication skills, including the ability to communicate in a remote team environment and adapt communications to audience

Nice-to-Have

• Master's degree
• Relevant pharmaceutical industry experience
• Experience with or ability to learn data visualization techniques, e.g. Spotfire, JReview, Tableau.
• Proficient experience using commercial clinical data management systems and/or EDC products

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