Senior Associate, Senior Central Monitor job opportunity at Pfizer.

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DateMore Than 30 Days Ago bot
Pfizer Senior Associate, Senior Central Monitor
Experience: 4-years
Pattern: full-time
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Senior Central Monitor

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degreeAssociate
loacation India - Chennai, India
loacation India - Chenna..........India

ROLE SUMMARY   The Central Monit or   is responsible for   ensuring the completeness,   quality   and integrity of the subject data in the clinical trial database under Risk Based Monitoring (RBM) mode. The areas of activity include but are not limited to: developing Risk-Based Monitoring system for applicable studies, ensuring key risk indicators (KRIs) properly defined and set up in the system to support the study, processing and reviewing study data in the system for the signal and action management, follow up for the issue resolution. The Ce ntral Monitor   ensures   risk based   monitoring activities   comply with   regulations, applicable Standard Operating Procedures (SOPs) and Processes   at all times   and is familiar with supported systems (RBM system, etc.) and able to troubleshoot and provide rapid response for all databas e issues. The Central Monitor   works with the global study team to meet the study   objectives .   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 (C 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   4   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.   Work Location Assignment: Hybrid Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Medical

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