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

<p style="color:!important"><span style="color:#000000"><span><b><span></span></b> </span></span></p><p style="color:!important"><span style="color:#000000"><span><b>ROLE SUMMARY</b> </span></span></p><p style="color:!important"><span style="color:#000000"><span>The Senior Central Monitor is responsible for ensuring the completeness, quality and integrity of the subject data in the clinical trial database under Risk Based Monitoring (RBM) mode. The areas of activity include but are not limited to: developing Risk-Based Monitoring system for applicable studies, ensuring key risk indicators (KRIs) properly defined and set up in the system to support the study, processing and reviewing study data in the system for the signal and action management, follow up for the issue resolution. The Senior Central Monitor ensures risk based monitoring activities comply with regulations, applicable Standard Operating Procedures (SOPs) and Processes at all times and is familiar with supported systems (RBM system, etc.) and able to troubleshoot and provide rapid response for all database issues. The Senior Central Monitor ensures quality oversight/control steps implemented in the central monitor activities. The Senior Central Monitor works with the global study team to meet the study objectives. </span></span></p><p style="color:!important"><span style="color:#000000"><span><b><span></span></b> </span></span></p><p style="color:!important"><span style="color:#000000"><span><b>ROLE RESPONSIBILITIES </b> </span></span></p><p style="color:!important"><span style="color:#000000"><span>General: </span></span></p><ul><li><p style="color:!important"><span style="color:#000000"><span>Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables. </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Provide technical expertise to set up and test study level Risk-based Monitoring system </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Review study level system outputs to process for the signal and action management </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Plan and execute communication plans &amp; methods to ensure customer satisfaction and enable improvements to be implemented during the course of a study.  </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Able to resolve conflicts, influence and communicate with key stakeholders and customers. </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Implement quality oversight/control steps implemented in the central monitor activities. </span></span></p></li></ul><p style="color:!important"><span style="color:#000000"><span><span></span> </span></span></p><p style="color:!important"><span style="color:#000000"><span>System setup Functions: </span></span></p><ul><li><p style="color:!important"><span style="color:#000000"><span>Review protocols to ensure the set-up, review and reporting requirements can be met and are standardized. </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Provide technical oversight, guidance and coordination for all the central monitor activities. </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Set up and test RBM system at study level to ensure system quality. </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Define key risk indicators (KRIs) in study system and ensure consistency between the standard level and the study level. </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Set up dictionary for data quality assessment DQA in study system </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Ensure RBM system align with the protocol and adhere to ICH GCP, SOPs, corporate standards and regulatory requirements. </span></span></p></li></ul><p style="color:!important"><span style="color:#000000"><span><span></span> </span></span></p><p style="color:!important"><span style="color:#000000"><span>Data review Functions: </span></span></p><ul><li><p style="color:!important"><span style="color:#000000"><span>Work with Study Team to define the issue resolution for the reviewing findings as signal and action.  </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Develop, implement and maintain Quality Control related documentations for RBM related activities to ensure data completeness and accuracy. </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>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. </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Work with Clinical Data Scientist (CDS) to ensure all signal and actions are properly mitigated and RBM systems properly released. </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Ensure lessons learnt during the course of the study are documented and shared with other central monitors/ study teams to facilitate cross-study learning. </span></span></p></li></ul><p style="color:!important"><span style="color:#000000"><span><span></span> </span></span></p><p style="color:!important"><span style="color:#000000"><span>  </span></span></p><p style="color:!important"><span style="color:#000000"><span>BASIC QUALIFICATIONS:  </span></span></p><ul><li><p style="color:!important"><span style="color:#000000"><span>Bachelor’s degree or above of equivalent experience in a scientific or business-related discipline required. </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Minimum 7 years of relevant working experience in the clinical development field. </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>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 </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Knowledge of clinical trial database and its applications  </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.) </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills. </span></span></p></li></ul><p style="color:!important"><span style="color:#000000"><span><span></span> </span></span></p><p style="color:!important"><span style="color:#000000"><span>Technical Skill Requirements: </span></span></p><ul><li><p style="color:!important"><span style="color:#000000"><span>Technical expertise and business experience in supporting clinical trials database development, data management, site monitoring, etc. </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations. </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>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. </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Works independently, receives instruction primarily on unusual situations </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Ability to organize tasks, time and priorities; ability to multi-task </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Ability to communicate effectively and appropriately with internal &amp; external stakeholders, locally and globally </span></span></p></li></ul><ul><li><p style="color:!important"><span style="color:#000000"><span>Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption. </span></span></p></li></ul><p style="color:!important"><span style="color:#000000"><span><b><span></span></b> </span></span></p><p style="color:!important"><span style="color:#000000"><span><b>PHYSICAL/MENTAL REQUIREMENTS</b> </span></span></p><p style="color:!important"><span style="color:#000000"><span>Primarily an office-based position involving sitting, walking to meetings, making presentations, etc.  </span></span></p>&nbsp;<br>Work Location Assignment:&nbsp;Hybrid<br><p style="text-align:inherit"></p><p style="text-align:left"><span><span><span><span><span><span><span><span><span>Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.</span></span></span></span></span></span></span></span></span></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Medical<p></p><p></p>