Senior Associate, Senior Central Monitor, Data Surveillance, Clinical Data Sciences

Job Description

Role Overview:As a Senior Central Monitor, your primary responsibility will be to ensure the completeness, quality, and integrity of subject data in the clinical trial database under Risk Based Monitoring (RBM) mode. You will play a crucial role in developing the Risk-Based Monitoring system for applicable studies, defining key risk indicators (KRIs), processing and reviewing study data for signal and action management, and following up for issue resolution. It will be your duty to ensure that risk-based monitoring activities comply with regulations, applicable Standard Operating Procedures (SOPs), and processes while working closely with the global study team to meet study objectives.Key Responsibilities:- Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes for meeting quality, timelines, and deliverables.- Provide technical expertise to set up and test study level Risk-based Monitoring system.- Review study level system outputs for signal and action management.- Plan and execute communication plans to ensure customer satisfaction and enable study improvements.- Resolve conflicts, influence key stakeholders, and implement quality oversight/control steps in central monitor activities.- Review protocols to ensure set-up, review, and reporting requirements are met and standardized.- Define key risk indicators (KRIs) in study system and ensure consistency with standard level.- Set up dictionary for data quality assessment (DQA) in study system.- Work with Study Team to define issue resolution for reviewing findings and develop quality control documentation for RBM activities.- Perform central monitoring activities, propose suggestions for signal and action management, and follow up with study team for action resolution.- Collaborate with Clinical Data Scientist (CDS) to mitigate signals and actions properly.- Document and share lessons learned during the study for cross-study learning.Qualification Required:- Bachelors degree or above in a scientific or business-related discipline.- Minimum 7 years of relevant working experience in clinical development.- Working knowledge of clinical development process and understanding of Phase I-IV concepts.- Previous experience in data management, including CRF design, database set-up, and data cleaning activities.- Knowledge of clinical trial database applications and Windows Environment.- Experience in Oracle, PL/SQL, SAS, Java, and relational database design.- Strong technical expertise in supporting clinical trials database development and data management.- Project management skills, effective communication, and ability to organize tasks and priorities.- Ability to communicate effectively with internal and external stakeholders.- Strong understanding of technologies for improving business processes.(Please note: Omitted additional company details as none were provided in the job description) Role Overview:As a Senior Central Monitor, your primary responsibility will be to ensure the completeness, quality, and integrity of subject data in the clinical trial database under Risk Based Monitoring (RBM) mode. You will play a crucial role in developing the Risk-Based Monitoring system for applicable studies, defining key risk indicators (KRIs), processing and reviewing study data for signal and action management, and following up for issue resolution. It will be your duty to ensure that risk-based monitoring activities comply with regulations, applicable Standard Operating Procedures (SOPs), and processes while working closely with the global study team to meet study objectives.Key Responsibilities:- Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes for meeting quality, timelines, and deliverables.- Provide technical expertise to set up and test study level Risk-based Monitoring system.- Review study level system outputs for signal and action management.- Plan and execute communication plans to ensure customer satisfaction and enable study improvements.- Resolve conflicts, influence key stakeholders, and implement quality oversight/control steps in central monitor activities.- Review protocols to ensure set-up, review, and reporting requirements are met and standardized.- Define key risk indicators (KRIs) in study system and ensure consistency with standard level.- Set up dictionary for data quality assessment (DQA) in study system.- Work with Study Team to define issue resolution for reviewing findings and develop quality control documentation for RBM activities.- Perform central monitoring activities, propose suggestions for signal and action management, and follow up with study team for action resolution.- Collaborate with Clinical Data Scientist (CDS) to mitigate signals and actions properly.- Document and share lessons learned during the study for cross-study learning.Qualification Re

Keyskills :
Quality ControlOraclePLSQLSASJavaDatabase ProgrammingProject ManagementData ManagementRegulatory OperationsTime ManagementTechnology EvaluationRiskBased MonitoringKey Risk Indicators KRIsSignalAction ManagementClinical Data Scientist CDS