SKILLS AND KNOWLEDGE:
- SDLC Clinical Trial Business Processes
- Cost/Benefit Analysis Requirements Documents (RS)
- System Integration System and User Acceptance Testing
Lead Business Analyst
- Requirement elicitation and translation to business requirement documents and functional specifications through 8 major releases.
- Later releases were focused on CRA (Monitor) productivity improvement.
- Subject matter expert for the user access security configuration across 25 classes of users and 300 screens.
- Creating various screen prototypes, process and data flows and use cases to help the users, the design team and support personnel understand the business requirements.
- Leading the design and build reviews that included users, developers, support and IT management.
- Tracked, tested and prioritized defects.
- Coordinated with release team for patch upgrades.
- Prioritizing a backlog of defects and enhancement requests for inclusion in releases.
- Assisting the business in transitioning from the as - is to the to-be processes.
- Process knowledge spans the following clinical domains: monitoring visit report, clinical and ancillary supplies, source document verification, protocol deviations, informed consent, recruitment planning and protocol amendments tracking.
- Collaborated with Development teams, Project Managers and Quality Assurance teams to review and approve all validation documents to ensure audit readiness.
- Review and modify all system test scripts created by a central testing group in HP Application Lifecycle Management (ALM). Assist business users with user acceptance test script and test data creation. Pre- and post-approve the artifacts of each test.
- Supporting the data set-up required to test and troubleshoot across multiple database instances: test, End-to-End, UAT, training.
- Providing analysis of reported compliance issues related to all aspects of the system but especially to the Monitoring Visit Trip Report. This key module of the system involves both on-line and off-line (disconnected) modes and an interface to automatically post the reports to the Trial Master File (TMF).
- Primary business analyst in year-long project using Confidential data to automatically provision both investigator site and company personnel to other systems such as EDC, Learning Management and Portals.
- Subject Matter Expert for how to use Confidential data for Reporting, Analytics and general use by approximately 40 integrating systems.
- Led the initiative to evaluate replacements for the legacy Confidential and select a vendor to implement the system.
- Deliverables included creation of RFPs, vendor demo management, process flows, readiness assessment and executive presentations.
- Responsible for the analysis and design of various applications including Tariff Rates, Budget and Revenue Management and Integrated Services Billing.
- Account Manager for customer service call centers supporting Long Distance, Wireless and Internet billing.
- Particular strength in utilizing routing technology such as Interactive Voice Response (IVR) to drive business cost management.