- 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 3 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
- Primarily an office-based position involving sitting, walking to meetings, making presentations, etc.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Ability to travel up to ~15%.
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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.