​​Manager, Central Monitor, Data Surveillance, Clinical Data Sciences​ job opportunity at Pfizer.

Home Jobs In India Tag: Central Monitor, Data Surveillance, Clinical Data Sciences​ ​​Manager, Central Monitor, Data Surveillance, Clinical Data Sciences​ position at Pfizer


DateMore Than 30 Days Ago bot
Pfizer ​​Manager, Central Monitor, Data Surveillance, Clinical Data Sciences​
Experience: General
Pattern: full-time
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Central Monitor, Data Surveillance, Clinical Data Sciences​

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

  ROLE SUMMARY   As part of the   Clinical Data Sciences (CDS) group , an integral delivery unit within the   Clinical Development & Operations (CD&O)   organization, the   Manager,   Central Monitor (CM) ,   D ata Surveillance   is responsible for   timely   and   high quality   risk-based monitoring analytics supporting the Pfizer portfolio.   The   Manager, Central Monitor, Risk Based Monitoring,   CDS   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.     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   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.     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 alignment with the protocol and adherence to ICH GCP, SOPs, corporate   standards   and regulatory requirements.     Data review Functions:   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 .         Organizational relationships and interfaces:   Interact with Clinical Data Scientist (CDS) at study level for deliverables.    Interact with other study team members at study level for deliverables.       BASIC   QUALIFICATIONS    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     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, DMP s   and data cleaning activities   Knowledge of   clinical trial database   and its applications    Knowledge of Windows Environment and its applications (Word, Excel ,   Power P oint , Project, etc. )   Experience in Oracle, PL/SQL, SAS, Java, relational database   design   and database programming skills   Knowledge of basic statistical principles     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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