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Sr. Business Analyst (Clinical Trial) Resume Example

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SR. BUSINESS ANALYST (CLINICAL TRIAL)
Professional Summary
  • Dedicated, results oriented Business/Systems Analyst professional with over eight years of Healthcare experience in Healthcare Insurance, Medical billing, Accounts Receivable, U.S. Health Insurance Portability, Accountability Act, EDI Transactions (834, 835, 837), HIPAA, MMIS, Medicare and Medicaid. Successfully bridged the knowledge and communication gap between Business and Technology channel groups in various situations. Able to work independently and as a team member. Experienced in auditing, analysis, research and resolution of contracted insurance and claim reimbursement issues in a timely manner.
  • Expert of all the phases of SDLC, Scrum/Agile, Kanban Methodology throughout the project life cycle.
  • Expert in Business Analysis, Project initiation, Scoping, Prioritization, Estimation, Planning, Executing, Tracking and Monitoring. Project timelines and Project milestones.
  • Managed on - shore and off-shore teams of varying sizes to deliver high quality project deliverables.
  • Experienced in conducting Daily Scrum meeting, Planning Sessions, Backlog updates, User Stories updates.
  • Used Microsoft SharePoint as a Web-based Content Management System as well as a Document/ Project Management tool.
  • Skilled in designing and preparing monthly status reports, assisting in corporate projects in health care, health economics model, and evaluating all clinical trial data.
  • Experience in ensuring employers and workers comply with safety legislation and that safety policies and practices are adopted and adhered to.
  • Experienced in healthcare revenue cycle, billing and claim process cycle (ICD-10 and CPT code), staffing/volume forecasting, ad-hoc business analysis, combine and utilize data from different sources (SQL database, MS Access, etc.), writing VBA scripts to aid accounting pro-forma reporting, create dashboards for operational, financial, marketing, human resource purposes.
  • Expertise in gathering/eliciting business requirements, detailing, converting business requirements to technical requirements using different tools and techniques.
  • Experienced in interacting with business users to identify their needs, gathering requirements and authoring Business Requirement Documents (BRD), General system Design (GSD), Functional Requirement Document (FRD) and Software Requirement Specification (SRS) across the deliverables of a project.
  • Highly analytical in developing the methods and measures to meet requirements, handling Change Request, prevent scope creep and solve any issues that arise during the project.
  • Ability to develop business rules, context data flow diagram, entity relationship diagram, workflow diagramming, prototyping and document current state, gaps and future state processes.
  • Skilled in managing Feasibility Studies, Scope Documents, Requests for Proposal and end-user support documentation.
  • Experience in utilizing SAS Procedures, Macros, and other SAS applications for data extraction, data cleansing, data loading and reporting.
  • Logs the bugs in JIRA and assists the developers in the resolution of bugs.
  • Experience creating Traceability matrix to better manage the requirement gathering process and keeping track of the milestones.
  • Experience in visualizing the design of the system using UML diagrams, Activity diagrams, and Web page mock-ups.
  • Executed SQL queries and documented them as part of validating the Business Object reports and for testing purposes.
  • Experienced in working and supporting Project Management (PMO), Mentoring & Coaching the team and Problem solving.
  • Detail-oriented Senior Financial Analyst with background leveraging extensive clinical experience with financial management and negotiation skills in clinical trial budgeting, leadership, accounting, analysis, and reporting.
  • Experience with web application development, and SAS based clinical trials applications.
  • Knowledge of HIPAA standards, EDI (Electronic data interchange) Transaction syntax such as ANSI X12.
  • Extensive knowledge Qualified Health Plans (QHP), Health Insurance Exchange (HIX) and Affordable care Act (ACA).
  • Worked with multiple Relational databases like MySQL, Oracle, Sql server and in depth knowledge in ETL tools (Pentaho, SSIS).
  • Participated in Joint Application Development (JAD), brainstorming sessions, reviews, walkthroughs, and customer interviews to gather customer requirements.
  • High degree of computer literacy in MS Office: Word, PowerPoint, advanced Excel skills (formulas, pivot tables, vlookup functionality), Visio, project, Access, and SharePoint for document sharing/collaboration.
  • Proficient in developing & automating reports, iteratively build & prototype BI dashboards using Tableau to provide insights at scale, solving for analytical needs of business team.
  • Managed reports, analysis and decision-making for change requests.
  • Prepared status reports, SLA reports, performance metrics and scorecards.
  • Experienced in conducting GAP analysis, User Acceptance Testing (UAT), SWOT analysis, Risk Analysis and mitigation plan, Cost benefit analysis and ROI analysis.
  • Proficient in offering care, medical management, coordination, supervision and facilitating daily operations of medical offices & with the ability to excel in fast-pacetime-sensitive environments
  • Strong analytical, problem solving and interpersonal skills; acquired credentials of medical profession having zeal to treat patients with empathy and compassion
  • Outstanding communication skills, self-motivated and goal-oriented with a high degree of flexibility, creativity, commitment and optimism
Skills

TECHNICAL SKILLS & EXPERTISE:

Process Methodologies: RUP - Rational Unified Process, UML - Unified Modeling LanguageWaterfall, SAFe, Agile, Scrum, Six Sigma, CMMI, BPM

Object-Oriented: Rational Rose

Data-Oriented: Erwin

Universal: VISIO, Irise Studio

Quality Management: JIRA, Mercury Quality Center, Track Wise, VersionOne, RTC

Reporting: SSRS, Cognos, MSAccess, Irise Manager

Project Management: MS Project, Excel Spreadsheets

Change Management: Bugzilla, Clear Quest, SharePoint

Configuration Management: PVCS, CVS, Clear Case, SharePoint

Testing: SIT, UAT, Unit test, Rational Robot, Rational Test Director, Win Runner, Load Runner and Manual Testing

Requirements Tools: Rational Requisite Pro, Irise Manager

Languages: PowerBuilder, C, C++, Visual Basic, PL/SQL, HTML, Java, J2EE

Databases: Oracle (9i), MS SQL Server, MS Access, ETL, TOAD

Office Tools: MS Word, Excel, PowerPoint, Project, Outlook, Lotus

Business Intelligence Tools: Tableau, Cognos

Healthcare Expertise: Provider Domain, 834, 837, EDI, HIE, Claims, Credentialing, HIPAA

Healthcare Applications: EPIC, IDX, Meditech, MBE- Market Prominence, Centricity

Healthcare Tools: IDX, CARE, Centrix, APTA Connect, HealthQuest, Macess, Edifecs, CCMS, Claim Check, Wizard, and APEX, Allscripts, Peoplesoft, Centricity

IT SM/AM Tools: Service Now, HP Service Manager, HP Asset Manager

Work History
Sr. Business Analyst (Clinical Trial), 02/2018 to Current
Iqvia Holdings Inc – Iowa City , IA
  • Enhancement related to pl/sql and sql for Oracle Clinicals (oracle product used by client for clinical trials)
  • Business / Functional Analysis of the Clinical Data Management Applications (EDM, RDC (TAO-Trial Access Online), SMT, I-Review, PRS, IBISecg, DLS, PC Imaging, EmBARC) . The tools help to support the IT part of the Life Sciences (like Clinical Trail and Discovery)
  • Involved in Order Management and Inventory Modules.
  • Production support on OM, Advance Pricing, Inventory.
  • Testing the New functionality related to OM, Purchasing, Advance Pricing, Inventory.
  • Worked on Price Lists, Qualifiers, Modifiers, Pricing Attributes in Advanced Pricing.
  • Responsible for requirement gathering, business process flow, business process modeling and business analysis.
  • Facilitated JAD sessions with management, users and other stakeholders to define the project and to reduce the time frame required to complete deliverables.
  • Conducted project kickoff meetings with team members to explain and assign roles / responsibilities, relationships with other groups, deliverable, timelines, assignments and status reporting.
  • Created minutes of meetings and published to all stakeholders highlighting discussion points and pending action points.
  • Performed as-is analysis, to-be analysis, data Analysis, Gap analysis, competitive analysis, comparative analysis, process flows and business flows.
  • Used Jira for writing Epic, user stories with acceptance criteria or user stories with use cases, used Confluence for upload documents.
  • Prepared BRD (Business Requirements Document), FRD (Functional Requirements Document) and N-FRD (Non-Functional Requirements Document).
  • Reviewed the business requirements document with the business and development team to understand the architecture and functionality of the application.
  • Understand user requirements and translate them to functional requirements/specification and assist end user with Epic request submissions obtaining team approval.
  • Coordinated with system architects and developers to convert business requirements into system requirements.
  • Worked on backlog grooming items and presented what items can be picked up in next sprint to the squad/scrum master.
  • Participated in sprint planning with PM/Dev/QA to conclude the User Story points and the effort estimates.
  • Used Definition of Done (DoD) as a checklist to verify whether all necessary value-added activities were completed, after a feature or sprint is done.
  • Facilitate business requirements gathering sessions with the client, and manage the creation of Use Cases/activity Diagrams and Functional Specifications using Microsoft Visio.
  • Conducts coverage analysis of clinical research trial procedures to delineate standard of care and research procedures; reaches out to research site to assist in determining charge direction.
  • Assists in feasibility review process by gathering information from Recruitment Core, Pharmacy and Finance Core for budgeting purposes .
  • During the Service Now implementation, I was involved in developing processes that support or interact with the Change Management process, Configuration and Asset management, Service catalog, incident and problem management.
  • Exported and extracted HEDIS measures from NCQA certified SQL-based software into user-friend MS Excel formats.
  • Implemented multiple ITSM modules:Incident, Change, Service Request, Asset, configuration, knowledge, problem, release, capacity, availability, and service level management.
  • Created reading material for better analysis and explanation of system flows.
  • Accurately forecast clinical trial timelines using advanced modeling and simulation techniques .
  • Develops process for participation in the reporting and improvement of QCDR measures to fulfill PQRS reporting requirements.
  • Reviewed statistical data on HEDIS measures and manages special projects that are related to disease prevention, and quality improvement.
  • Collaborate with Clinical and IT staff to support HEDIS business requirements and maintain consistency and integrity of data collection and storage.
  • Gathering user requirements and conducting in depth analysis of the same
  • Used SQL query to analyze the Pfizer source systems and existing data warehouse data. Prepared data mapping documents to build the new data mart and Tableau reporting.
  • Resolving the complex requirements into simpler fragments and conveying it to the technical team for faster and efficient development.
  • Coordinated with Data Analyst, ETL and UI interface Developers and did tasks in construct phase.
  • Generated and designed reports for HEDIS specifications to analyze complex data through internal databases.
  • Reviewed Stored Procedures for reports and wrote test queries against the source system (SQL Server) to match the results with the actual report against the Data mart (Oracle).
  • Conducts coverage analysis of clinical research trial procedures to delineate standard of care and research procedures; reaches out to research site to assist in determining charge direction.
  • Educating external and internal users on the product and its usability.
  • Preparation of process flow diagrams for reviews with clients.
  • Participating in testing process and coordinating with QA team in each test cycle.
  • Create and run analytical reports as needed using tools such as Reporting Workbench, Epic Cubes, BI Portal and other reporting tools.
  • Assist in the co-ordination and management of various activities associated with clinical trial planning and initiation including clinical trial budget and agreement review, third-party vendors identification, and site/study feasibility assessment; among other responsibilities.
  • Involved in Project co-ordination, Onshore/Offshore Co-ordination, optimal service delivery and Knowledge management.
  • Submits ticket /issues in accordance with DFCI issue management processes. Escalates issues and ask questions to bring issue to closure, when necessary.
  • Performed UAT and participated in writing test plans, and developed different testing strategies like black box testing and load testing.
  • Staff Augmentation and mentor new team members.

Environment: Agile/Scrum, Guidewire Policy Center, Claim Center, SQL Server, Microsoft Visio, HP Service Manager, Oracle EBS 11.5.10 (Oracle Inventory, Oracle Supply Chain, Advance Pricing), CRM, DML,MS Office, HTML, CSS, Informatica Power Center 9.1/8.6, Rational RequisitePro, Java, .NET, Business Objects, ServiceNow .

Sr. Business Analyst, 07/2016 to 02/2018
Iqvia Holdings Inc – Jackson , MS

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.

Sr. Business Analyst, 01/2014 to 06/2016
Cb Richard Ellis – East Hanover , NJ
  • 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 Noetixcorp. 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 progress and 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 .

Associate Business Analyst, 02/2012 to 05/2014
Biogen Inc. – City , STATE

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.
Education
Master of Science: 05/2010
New Jersey Institute of Technology - City, State
Bachelor of Science: 05/2006
Maharishi Dayanand University - City
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Resume Overview

School Attended

  • New Jersey Institute of Technology
  • Maharishi Dayanand University

Job Titles Held:

  • Sr. Business Analyst (Clinical Trial)
  • Sr. Business Analyst
  • Associate Business Analyst

Degrees

  • Master of Science : 05/2010
    Bachelor of Science : 05/2006

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