ROLE SUMMARY

As part of the Clinical Data Sciences group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Associate Manager, Central Monitor (CM), Data Surveillance is responsible for timely and high quality risk-based monitoring analytics supporting the Pfizer portfolio with minimum supervision. The Associate Manager, Central Monitor, Data Surveillance will support an approach to clinical trial monitoring which utilizes data and site level information to determine needs for performing on-site, remote and centralized activities and focuses resources on risks that have the most potential to impact patients' safety and data quality, with supervision.

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 cross-functionally with key stakeholders and customers.

• 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.

• Ensure RBM system alignment with the protocol and adherence to ICH GCP, SOPs, corporate standards and regulatory requirements.

• Work with Study Team to define the issue resolution for the review of findings as signals and actions.

• Develop, implement and maintain Quality Control related documentation for RBM related activities to ensure data completeness and accuracy.

• Perform central monitoring activities including review system outputs, propose suggestions for signal and action management, and follow up with study team for the action resolutions.

• Work with Clinical Data Scientist (CDS) to ensure all signals and actions are properly mitigated and RBM systems properly released.

• Interact with Clinical Data Scientist (CDS) at study level for deliverables.

• Bachelor's degree or above in a scientific or business related discipline required.

• 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

• Minimum 5 years clinical trial experience required

• 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

• Knowledge of basic statistical principles