Senior Associate, Central Monitor, Data Surveillance, Clinical Data Sciences

Application Instructions: Please submit your resume in English when applying. Work Location Assignment:  Buenos Aires, Argentina (Complejo LUMINA – Office Park). This role follows a hybrid model. Colleagues are expected to work from the assigned Pfizer office 2–3 days per week , or as required by business needs. Use Your Power for Purpose Our mission is straightforward: support healthcare decisions that ensure the safe and effective use of medications. Whether you are developing the framework to ensure our evidence is scientifically robust, providing unbiased and medically essential expertise, or exploring ways to bridge data gaps, your role is vital. By ensuring our evidence is sound and offering necessary medical insights, we strive to improve patient care and treatment efficacy. The Senior Associate, Central Monitor 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 Senior Associate, Central 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 database issues. The Senior Associate, Central Monitor ensures quality oversight/control steps implemented in the central monitor activities activities and may be required to perform tasks as CM Program Oversight Lead. The Senior Associate, Central Monitor works with the global study team to meet the study objectives. What You Will Achieve In this role, you will: 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 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 Dat