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

Pfizer; San Isidro; Ibrido; ARS 136.310.000 - 196.892.000; Tempo pieno

Descrizione del lavoro

Pfizer in Buenos Aires, Argentina, is seeking a professional to support global strategies for risk-based monitoring and data management within a hybrid work model. The role focuses on ensuring quality and timely outcomes across study activities.

You will lead RBM setup, review outputs, and coordinate with study teams and stakeholders to drive improvements and effective communication throughout the study lifecycle.

Competenze

• 3–5 years in clinical development or data management.
• Experience with RBM concepts, KRIs and monitoring plans.
• Knowledge of Oracle databases and SAS/SQL.

Mansioni

• Implement global strategies, initiatives, processes, and standards to ensure quality, timelines and deliverables.
• Provide technical oversight to set up and test study-level RBM.
• Review study-level system outputs and processes for signal and action management.
• Plan and execute communication plans to ensure customer satisfaction and enable improvements during a study.

Conoscenze

RBM

Clinical Data Management

Oracle

SQL/PLSQL

SAS

Study Monitoring

Formazione

Bachelor's degree in life sciences

Strumenti

Oracle

PL/SQL

SAS

Java

Descrizione del lavoro

Use Your Power for Purpose

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.

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.

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 Data Scientist to ensure all signal and actions are properly mitigated and RBM systems properly released.
• Ensure lessons learnt during the course of the study are documented and shared with other central monitors/ study teams to facilitate cross-study learning.

Here Is What You Need (Minimum Requirements)

Bachelor’s degree or above of equivalent experience in a scientific or business related discipline required. 3 - 5 years working experience in the clinical development fields. 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.

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 in relating to colleagues and associates both inside and outside the organization.Works independently, receives instruction primarily on unusual situationsAbility to organize tasks, time and priorities; ability to multi-taskAbility to communicate effectively and appropriately with internal & external stakeholders, locally and globallyStrong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.

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.

Medical Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.