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Senior Associate, Central Monitor, Risk Based Monitoring
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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.

Why Patients Need You
Pfizer Global Product Development colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

Position Summary
It is our mission to strengthen the oversight of our clinical data through stronger ownership, control, and visibility. You will help ensure the completeness, quality and integrity of the subject data in the clinical trial database under our Risk Based Monitoring (RBM) model, including developing Risk-Based Monitoring analytics system for applicable studies, and ensuring key risk indicators (KRIs) are properly defined and set up in the system to support the study. You will support risk-based monitoring activities in compliance with regulations, applicable Standard Operating Procedures (SOPs) and Processes.

Key Responsibilities
General:

  • Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.
  • Resolve conflicts, influence and communicate with key stakeholders and customers.

System Setup Functions:

  • Set up and test RBM analytics 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 analytics system align with the protocol and adhere to ICH GCP, SOPs, corporate standards and regulatory requirements.

Data Review Functions:

  • 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.
  • 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
Must-Have

  • Bachelor’s degree in a scientific or business-related discipline
  • Minimum of three (3) years of Data Analytics, Data Management, Data Science or related data experience
  • Experience communicating/interacting with internal and external stakeholders, locally and globally
  • Strong verbal and written communications skills

Nice-to-Have

  • Extensive knowledge of data analytics and statistical methodology to help organize and analyze data
  • Technical proficiency in data mining and exploratory analysis, data models, data visualization tools
  • Hands on experience in any of the following programming languages R/R-Shiny/Python/SQL, AWS, Power BI/Spotfire
  • Experience supporting clinical trials through data operations and reporting of clinical trial data, and/or database development, data management and site monitoring

Work Location Assignment: On Premise

Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!

Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

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