Senior Central Monitor

3 weeks ago


delhi, India Pfizer Full time
BASIC QUALIFICATIONS:
3 - 7 years working experience in the Central Monitoring (RBM)
Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills.
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
ROLE RESPONSIBILITIES
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.
Implement quality oversight/control steps implemented in the central monitor activities.
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.

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