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

Work Location: 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.

Our mission is straightforward: support healthcare decisions that ensure the safe and effective use of medications. 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 core areas of activity include:

• Develop a Risk‑Based Monitoring system for applicable studies.
• Ensure key risk indicators (KRIs) are properly defined and set up in the system to support the study.
• Process and review study data in the system for signal and action management.
• Follow up for issue resolution.
• Ensure risk‑based monitoring activities comply with regulations, SOPs and processes.
• Be familiar with supported systems (RBM system, etc.) and able to troubleshoot and provide rapid response for all database issues.
• Implement quality oversight/control steps in the central monitor activities.
• May be required to perform tasks as CM Program Oversight Lead.
• Work with the global study team to meet study objectives.

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 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.
• Resolve conflicts, influence and communicate with key stakeholders and customers.
• Implement quality oversight/control steps 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 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 aligns with the protocol and adheres to ICH GCP, SOPs, corporate standards and regulatory requirements.

Data Review Functions

• Work with Study Team to define issue resolution for findings as signal and action.
• Develop, implement and maintain quality control related documentation for RBM activities to ensure data completeness and accuracy.
• Perform central monitoring activities including review of system outputs, propose suggestions for signal and action management, and follow up with study team for action resolution.
• Work with Clinical Data Scientist to ensure all signal and actions are properly mitigated and RBM systems properly released.
• Ensure lessons learned during the course of the study are documented and shared with other central monitors/study teams to facilitate cross‑study learning.

Qualifications

• Bachelor’s degree or equivalent experience in a scientific or business‑related discipline.
• 3–5 years of working experience in the clinical development field.
• Working knowledge of the 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 such as 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.

Technical Skill Requirements

• 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.
• Ability to work independently, make instruction for unusual situations.
• Ability to organize tasks, time and priorities; ability to multi‑task.
• Strong understanding of state‑of‑the‑art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.

EEO Statement

EEO (Equal Employment Opportunity) & Employment Eligibility: Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI‑use guidelines available on Pfizer Careers.