Manager Senior Central Testing Analyst

Role Summary

As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Clinical Development & Operations (CD&O) organization, the Manager, Senior Central Testing Analyst is responsible and accountable for delivery of User Acceptance Testing (UAT) activities and ensure the deliverables meet quality standards and agreed timeline for the studies assigned to the group. The Manger, Senior Central Testing Manager will also work closely with the Clinical Data Scientists, Data Managers, Clinical Database Management, Data Management Reporting and Analytics (DMRA) and other groups within Clinical Data Sciences (CDS) for timely delivery of CDS responsibilities. The role has additional responsibilities supporting development, system upgrade/migration/technical processes, automation tools validation and accountable for timely and high-quality deliverables supporting the Pfizer portfolio.

Role Responsibilities

• Responsible and accountable for activities, including but not limited to the testing of CRF design, Database building, Acquisition & Processing of electronic data such as external eData, Lab Data, ECG Data, PK/PD Data, etc., Documentation Processing, edit checks/validation, validation of exceptional reports/listings.
• Responsible for the study assignment and allocation of work for the group.
• Manages work done by people within a matrix but may have responsibilities as a people manager in select cases.
• Create and track resource allocation and resource forecast for the portfolio supported.
• Perform UAT documentation peer review and QC of deliverables as needed.
• Measure and monitor the operational metrics and ensure the metrics targets are met.
• Perform risk assessment and mitigate risk.
• Perform RCA and CAPA for quality issues.
• Accountable for high quality and on time delivery for task assigned to UAT team.
• Participate in training and mentoring of UAT analysts and Data Managers
• Directly supports knowledge development of others in Central testing process that support the accuracy and integrity of UAT.
• Track the lessons learned and build knowledge repository.
• Ensure the consistent use and application of applicable data standard and ensures data quality and consistency across programs and repositories.
• Streamline/Standardize the Scripts for Standard Forms/Edit Checks/Reports.
• Participate in Data Management meetings with Clinical Data Scientist or Study Data Manager to prioritize and revisit UAT timeline.
• Ensure work carried out in accordance with applicable standard operating procedures and working practices.
• May involved in special projects and automation projects in UAT space.
• Conduct team meeting and UAT forum.
• Participate in UAT feedback meetings and CDS forum to represent UAT team.
• Drive innovation and continuous process improvement session for UAT team
• Track the status of ideas proposed and bring it to closure.
• Responsible for performance evaluation of direct reports.
  
  

• Bachelor’s degree minimum requirement. Health Sciences experience or Technology degree preferred. At least 10 years of experience in Clinical Data Management, performing complete data review activities, in a CRO or a Pharma Company.
• Must have experience writing test cases and performing UAT.
• Must have knowledge in clinical data management processes and principles in area of responsibility.
• Previous experience within a database management role, understanding key processes and principles associated with CRF design, database build (including edit checks, validation, and outputs), data transfer activities, listing and reporting. Awareness of clinical development and pharmaceuticals as a regulated industry
• Awareness of healthcare regulatory authorities (e.g., FDA, Health Canada)
• Good knowledge and understanding of the Software Development, Life Cycle (SDLC) testing methodology and document management.
• Demonstrates required verbal and written communication skills including ability to communicate remotely.
• Capable to learn technical data systems.
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
• Prior experience in project management and people management preferred.