1+ months

EG-Central Monitor I, Risk Based Monitoring, DMM

Pfizer
Wuhan
**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

+ Execute communication plans & methods to ensure customer satisfaction and enable improvements to be implemented during the course of a study.

+ Provide technical support to resolve conflicts, influence and communicate with key stakeholders and customers.



System setup Functions:



+ 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 align with the protocol and adhere to ICH GCP, SOPs, corporate standards and regulatory requirements.



Data review Functions:



+ Provide technical support to define the issue resolution for the reviewing findings as signal and action.

+ 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 (CDMM) to ensure all signal and actions are properly mitigated and RBM systems properly released.



BASIC QUALIFICATIONS :



+ Bachelor's degree or above of equivalent experience in a scientific or business related discipline required.

+ Technical expertise in supporting clinical trials database development, data management, site monitoring, etc.

+ Familiar with the processes associated with clinical study management, data management, and regulatory operations.

+ Technical capabilities, 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 with internal & external stakeholders, locally and globally

+ Minimum 1 year experience related to clinical trial (CRA, DM, Programmer, etc.)



PREFERRED QUALIFICATIONS :



+ 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.



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Medical



\#LI-PFE
Posted: 2021-03-11 Expires: 2021-04-28

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EG-Central Monitor I, Risk Based Monitoring, DMM

Pfizer
Wuhan

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