Pfizer Risk Based Monitoring in Groton, Connecticut
As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Central Monitor (CM) is responsible for timely and high quality risk-based monitoring analytics supporting the Pfizer portfolio. The Central Monitor 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.
Central Monitor - Manager
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.
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 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
Bachelor's degree or above in a scientific or business related discipline required.
minimum 5 years data management/programming or data mining experience.
Preferred Additional Experience:
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
Knowledge of basic statistical principles
EEO & 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, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.