SUMMARY

• Senior Business Analyst with 13 years of IT and Clinical experience with ability to work independently and manage business expectations with a delivery - focused approach to work; ability to build and maintain strong working relationships with business sponsors, and technical specialists. Deep Pharmaceutical domain experience.
• Diversified experience as a Business Analyst/PM in various industries including Clinical Information software, Resource Management tools, Business Relationships.
• Comfortable as Lead and Mentor with experience in resources management and product training.
• Extensive experience in Rational Unified Process (RUP), Agile, Software Development Life Cycle (SDLC) processes and methodologies.
• About eight years of experience in eliciting client requirements through interviews, workshops, existing systems documentation and future state requirements and procedures in Agile.
• Proficient in writing Functional Specifications, Manuals and Release Notes.
• Experience in reviewing test procedures, test scripts, analyzing bugs, and proactively supervising User Acceptance Testing (UAT) release process.
• Experience with understanding "As Is" business processes and application portfolios and subsequent realization of "To Be" processes using techniques such as Fit-Gap Analysis.
• Knowledge of project management tools like MS-Project for timely and scheduled project management and status reporting to stakeholders.
• Strong analytical, problem-solving and communication skills, deadline oriented delivery with particular emphasis on clear scope, resources, quality, and time management.
• Ability to understand, analyze, and design business processes, models and workflows with the objective of providing recommendations for the best use of technology for improvement.

TECHNICAL SKILLS

Front-End Tools: MS Office, MS Project and MS Visio

Data Bases: Microsoft Access, MS SQL Server

Other Tools: Documentum, Test Director, SAS, TOAD, PROTON (Proton- HPQC tool)

PROFESSIONAL EXPERIENCE

Confidential

Business Analyst

Responsibilities:

• Provide aggregated and consolidated clinical data as a patient data repository (Data Hub) to support Clinical Convergence objectives (UNIFY).
• Enable data standardization to align with regulatory guidelines.
• Establish the ability to integrate data managed by external business partners through a secure platform.
• Improve internal advanced analysis capabilities by enabling earlier and more effective decision-making around clinical development programs.
• Streamline the process and time requirements to respond to Health Authorities and to defend product claims.
• Support data mining and innovative future capabilities (e.g. Translational Medicine)
• Coordinate with business users to gather requirements, one on one session, meetings, demos to define business process, business process risk analysis as per project.
• Conduct requirements sessions with business and technical stakeholders to document business and functional and Technical requirements specifications
• Develop requirement use cases, use case models, user interface wireframes.
• Analyzed the AS-IS processes, identify improvement opportunities with client stakeholders
• Define and document TO-BE processes in collaboration with Stakeholders, Technical team.
• Review requirements documentation with business and technical stakeholders, in corporate feedback and get approvals.
• Provide clarification on requirements to technical and test teams
• Collaborate with test team, Review test cases and ensure alignment of Test cases with requirements

Confidential

Sr. Business Analyst/Project Manager/Application Manager

Responsibilities:

• Coordinated with business users to gather requirements, conduct JAD sessions, one on one sessions, meeting, deep dives and workshops to define business process, business process risk analysis as per project.
• Worked with business users to develop User Acceptance Test (UAT)/ PQ (performance qualification) objectives, testing approaches/ techniques and test plans in order to verify and accept that business/user requirements have been met by creating Traceability Matrix.
• Worked on Clinical Data Management systems like OC, CT4, EDC autoloader and Clinical Trial Management tools like Clintrial and also on Medical Affairs.
• Experience in Veeva Vault, regulated content management and collaboration solutions.
• Co-coordinated with Protocol Trial leaders and associated Clinical Trial team, (responsible for reviewing/endorsing the protocols), Therapeutic Area Heads, Drug Regulatory Affairs personnel, Protocol review committee, Clinical Operations Review Board, Key Opinion Leaders and external independent bodies (like Health authorities, Institutional Review Board) for gathering requirements, understand business process.
• Responsible for authoring, reviewing and approving IQ (Installation Qualification), OQ (Operation Qualification) and PQ (Performance Qualification).
• Served as liaison between Clinical business users and IT.
• Responsible for User Requirements Specifications, Functional / Design Specifications, Traceability Matrix, Test Plan and all of the testing and coordinating activities.
• Deployed iPADs in countries like US, Japan, Korea, Argentina, Israel, Turkey, Australia, Russia, UK, Belgium, Netherlands.
• Deployment involved onboarding countries to iFM project/application by providing overview and understanding to various stakeholders.
• Coordinated with local IT, Business and Finance team on setting up process of delivering iPADs to local countries CRAs.
• Coordinated set-up of local help desk and help desk training for each countries and setting up iFM Application Training for Trainer, Super Users and CRAs once the iPADs were delivered.
• Created user survey to gather information on usage of iFM application through iPAD and challenges faced in due course.
• Coordinated post deployment activity for each country.
• Handled finance (Raised Capital Acquisition Request) for India (end to end process) for onboarding resource for iFM project and assets.

Confidential, Groton, CT

Sr. Business Analyst

Responsibilities:

• Coordinated with business users, business technology along with Subject Matter Expert to define processes and gather requirements around Oracle Clinical and all inter dependencies related by conducting one on one meeting, JAD sessions, deep dive sessions.
• Involved in analysis and design phase of ELC process to gather business/user requirements, stakeholder analysis, traceability matrix, support plan, deployment and documenting them.
• Worked on Clinical Trial Management Systems like RightTrack, Onsite, EDC Trial Manager, Clinical Data Management systems like Autoloader for OC, OC 4.5.3 and reporting tools such as I-Review/J-Review, Clinical Data Analysis and reporting tool like CDARS and knowledge of data warehouse applications including CIDER2 and CIDER3. Knowledge of MedDRA, WHO dictionary and digital library.
• Developed User Acceptance Test (UAT) objectives, unscripted testing approaches/ techniques and test plans in order to verify and accept that business/user requirements have been met by creating Traceability Matrix.

Confidential, Hopewell, NJ

Sr. Business Analyst

Responsibilities:

• Consulted with various subject matter experts to define for EmBARC various drugs in different stages of trials.
• Conducted JAD sessions between business users and Subject Matter Experts.
• Involved in inception phase of SDLC process to gather requirements through open-ended discussions, brainstorming sessions, role-playing and prototyping.
• Documented user requirements specification using SDTM (Study Data Tabulation Model) methodology.
• Collected and documented policies, calculation methods, business processes as well as business rules. Responsible for identifying and documenting business rules according to CDISC (Clinical Data Interchange Standards).
• Involved with EDO (External Data Operations) which uses LIMS (Laboratory Information Management System), for managing all laboratory based operations and functions, Safety Data Sheets.
• Worked with various therapeutic areas in Clinical Department like Toxicology, Oncology, Metabolics, and Cardiovascular.
• Performed data quality checks and analyzed data for inconsistencies.
• Used data mining applications to generate models and refined rules based on data analysis.
• Performed business and system analysis towards resolution of reported application issues documenting all resolutions.
• Contributed to organizational change management by facilitating robust User Acceptance Testing and supported training phase of the project and attended higher level meetings for status updates.

Confidential, Rochester, MN

Sr. Business Analyst

Responsibilities:

• Worked with business users for gathering/defining business requirements, writing functional specifications and translating statement of work into business and system level requirements, maintaining traceability matrix by means of regular JAD sessions with development team and similar co-ordination with QA team.
• Used UML methodologies to create Use Cases, Process Flows, Sequence Diagrams, and Activity Diagrams using Visio.
• Worked with business staff to develop User Acceptance Test (UAT) objectives and test plans in order to verify and accept that business requirements have been met.
• Demonstrated product prototype to Product Analyst for approval and suggestions.
• Clinical trials experience includes to collect, monitor, prepare documents and validate Clinical data as per protocol.
• Assisted with serious adverse event reporting and reconciliation.
• Reviewed and maintained functional test case status for functional testing of the components of this project in Test Director.