Sr. Associate Central Monitor, Risk Based Monitoring, DMM

ROLE SUMMARY

The Sr. Central Monitor is responsible for ensuring the completeness, quality and integrity of clinical trial data in Pfizer's Risk Based Monitoring (RBM) ecosystem. The areas of activity include but are not limited to: developing Risk-Based Monitoring system for applicable studies, ensuring key risk indicators (KRIs) are properly defined and configured to support the study, processing and reviewing study data for risk signals and action management, and following up through issue resolution. The Sr. Central Monitor ensures risk-based monitoring activities comply with regulations, applicable Standard Operating Procedures (SOPs) and processes at all times. S/he will be the translator between the technical team and study team, delivering end to end support of clinical trials risk-based approaches.

ROLE RESPONSIBILITIES

General:

• Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.
• Use clinical trial process experience to translate study risks into technical specifications that will support monitoring in a risk-based approach.
• Review RBQM system output to tell a compelling story of operational and data risk for study team action.
• 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.
• Use project management skills to independently oversee the on-time execution of study deliverables.

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.
• Define RBM system requirements at the study level to ensure quality and study objectives are supported.
• Define appropriate study-specific key risk indicators (KRIs).
• 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 documentation 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.

BASIC QUALIFICATIONS:

• Bachelor’s degree or above or 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 clinical trials, understanding key processes and principles associated with clinical database set-up, external data flow, and site monitoring activities.
• Knowledge of clinical trial databases and all clinical trial data sources.
• Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.).

Technical Skill Requirements:

• Technical expertise and business experience in supporting clinical trials such as obtained through 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.
• Self-motivated with an ability to organize tasks, time and priorities; ability to multi-task.
• Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally.
• Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.

PHYSICAL/MENTAL REQUIREMENTS

• Primarily an office-based position involving sitting, walk