Sr. Business Analyst (Clinical Trial) Resume Example

Responsibilities:

• Responsible for analyzing requirements and develop functional specifications.
• Responsible for performing root cause analysis on all product support related issues.
• Responsible for Collecting and documenting business processes as well as business rules.
• Translated the business needs into system requirements, communicating with the business on a non-technical level, and with the System Analyst on a more technical level.
• Accountable Discrepancy Management and Quality Control.
• Responsible for writing study summaries and review protocols.
• Developed view templates and key templates for Data extraction.
• Responsible for serious adverse events and Case Report Form (CRF) completion, writing study summaries, and review protocols
• Responsible for entering clinical data and run Data Validation Reports.
• Enter unverified records and flag any issues via an operator comment to ensure that data is available for validation.
• Study summary investigator brochures and IND annual updates for safety data verification.
• Created Use Case diagramsusing UML and Business Process Models using MS-Visio.
• Create and maintain Responsibility Assignment Matrix (RAM), define Application Deployment Schedule (ADS), Distributed Application Implementation Plan (DIP), Deployment Staff Plan (DSP), Distribution Lists (PDL) documentation and training materials for application changes.
• Develop rollout, transition, and implementation checkout plans.
• Lead project strategy meetings and JAD sessions.
• Support process improvement efforts, EDP compliance.
• Conduct reviews to assure compliance to specifications and standards.
• Provide production support for applications 24hrs a day, seven days a week when assigned as a contact.
• Respond to user/operator requests and inquiries, as appropriate.
• Aid in structure testing and enter validation test data.
• Develop and execute test scripts for unit testing.
• Verify unit test results.
• Responsible for creating master project test plan (Regression and UAT).
• Determine test approach for unit testing stage for releases/enhancements.
• Prepare cycle test environment for user acceptance test (UAT).
• Assist in UAT process with business customers.
• Obtain sign-off from business customers on UAT.
• Resolve testing issues and correct defects.
• Document any testing issues and resolutions.
• Update Change Control schedule with upcoming production releases.
• Initiate and complete Turnover Package Process when necessary.
• Monitor production of recently migrated components.
• Participated in cross training initiatives.
• Assist Team Lead in estimating level of efforts (LOE) and scoping with the input of SME team members.
• Provide timely work request status to the Team Lead.
• Contribute to the development of training materials for new processes developed by the team.

Environment: Inform Oracle Clinical, Oracle, Java, Windows XP, Crystal Reports, MS-office (Outlook, word, Excel, Visio, Power Point, and Project), HP service desk, HP QTP (Test Director 10.0), Crystal Reports.

• Worked in different types of Projects at ABBOTT such as CTMS Clinical Trial Management System and CDC Clinical Document Control .
• Worked with requirement gathering of Noetix reporting tool by interacting with the various SMEs of Abbott the Noetix corp. through interviews and prototyping.
• Responsible for conducting Joint Application Development JAD sessions with the Noetix Corporation Project managers of Abbott for the requirement gathering of CTMS-Noetix integration project.
• Responsible for finalizing the requirement document for the customization of the Noetix reporting tool.
• Took an active part in sizing of the CTMS project.
• Responsible for preparing the RFP Request for Proposal according to the guideline for the vendor selection purpose. Responsible for the development of Business Context diagram along with the SME for the integration project using Microsoft Visio.
• Completed the BRD along with the other Business analyst. Prepared the Functional Design Document with Use casesand Activity diagram covering all the business needs.
• Responsible for creating maintaining RequirementTraceability Matrix in order to track the development and QA process.
• Closely involved with the QA team assisted them to develop quality Test cases by referring the Use cases.
• Assisted the QA team to complete the performance testing of the integration project.
• Assisted with the Project Manager to define project milestones, schedules, monitoring progressand updating plans using MS Project.
• Responsible for documenting the Abbott Siebel eClinical installation user manual for the development and QA team.
• Played an active role in the UAT and the release of CTMS integration project.

Environment: Scrum, Noetix, UML, Siebel eClinical, TOAD, MS Visio, Remedy Bug tracking tool .

oles and responsibilities:

• Worked on Service Now under ITIL framework and resolved all issues within SLA.
• Interacted with client as SPOC and gathered requirements to ensure proper delivery in order to meet all the milestones with high quality.
• Unit testing of newly developed protocols.
• Coordinated with various stakeholders for detailed requirements and prepared User stories.
• Responsible for the preparation of standard operating procedures, project/clinical data management plan, define data entry/validation conventions.
• GCP Good Clinical Practice of electronics recordings and submission of clinical data.
• Prepared BRD, FRS, User story, Functional and non-Functional documents with respect to Clinical trials.
• Mapping of data for the early stage development clinical trials study through an application named Trial Setup.
• Conducted Joint meeting with developers and testers and explain about the application functionality.
• Created UML diagrams including Use Case Diagrams, Activity Diagrams, and Sequence Diagrams.
• Created and delivered study-specific site training. Processed Change Requests, Reviewed the data entered by investigational site staff and initiated end-of-study PDF rendering.
• Performed root cause analysis and suggested workarounds and/or solutions for recurring issues.
• Conducted weekly review meetings for the development team to know development status and any risks.
• Identified the Security Risks in the application being built and addressed them in the requirement document to avoid the security breaches.
• Maintained Known Error Database KEDB for the swift resolution of recurring issues and transferred knowledge for seamless handover of the project to new team members.
• Preparation of reports and presentation to client.