Senior Central Monitor

3 weeks ago

Chennai, 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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