Project Quality Assurance

NILEEMA VERMA

Contact: 732-***-**** (*******.*****@*****.***)

Business Analyst with 8 years of Clinical & IT experience with the ability to work independently and

manage business expectations with a delivery focused approach to work; ability to build & maintain

strong working relationships with senior and junior business sponsors, as well as technical specialists.

Summary:

• Diversified experience as a Business Analyst in various industries including Clinical

information software, Resource Management tools, Business Relationships.

• Comfortable as Lead and Mentor with experience of resources management and product

training.

• 4 + years of experience in Rational Unified Process (RUP), Rational Clear Case,

Software Development Life Cycle (SDLC) processes Methodologies and SDLC tools.

• 7 + years of experience in soliciting client requirements through interviews, workshops,

existing systems documentation and procedures in Agile and Managed fashion.

• Extensive experience in component diagram, class, sequence and activity diagrams,

Collaboration diagram, Deployment diagram, State chart diagram, and Data model Diagram

using MS Visio

• 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

the subsequent realization of “To Be” processes using techniques such as Fit Gap

Analysis.

• Knowledge and nowise 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 and workflows with the

objective of providing recommendations for the best use of technology for improvement.

TECHNICAL SKILLS:

• Front End Tools: MS Office (Word, Excel, Access, PowerPoint, and Outlook), MS project

and MS Visio

• Data Bases: Microsoft Access, MS SQL Server

• Operating Systems: Microsoft Windows XP, NT, 2000, 98, 95 & Vista

• Other Tools: Documentum, Test Director, SAS, TOAD

EXPERIENCE:

Bristol Myers & Squibb, Hopewell, NJ Jul 2007 – Present

Project: Enhanced Biometric Analysis and Reporting Capability (EmBARC)

Role: Sr. Business Analyst

Bristol Myers Squibb is one of largest Pharmaceutical companies in the world. It is one largest research

and development organization in field of Cancer, Cardiovascular and Neurological Drugs.

Project: Enhanced Biometric Analysis and Reporting Capability (EmBARC), the project involved

implementation of a set of capabilities to improve Global Biometric Sciences (GBS) system perform its

Data Analysis and Reporting business within the Clinical Research and Development Process.

Responsibilities:

• Consulted with various subject matter experts to define EmBARC for various drugs in

different stages of trials. Conducted JAD sessions between the business users and the Subject

Matter Experts.

• Involved in Inception phase of SDLC process to gather requirements and document

them. Gathered user and business requirements through open ended discussions, brainstorming

sessions, role playing and prototyping.

• Documented the user requirements specification by using SDTM (Study Data

Tabulation Model) methodology, prioritized them and converted them as system requirements

that must be included while developing the software.

• 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, Cardio vascular.

• Performed data quality checks and analyzed data for inconsistencies. Used data mining

applications to generate models and refined rules based on the data analysis. Performed

business and system analysis towards the resolution of reported application issues documenting

all resolutions.

• During the design phase, worked with the development team to ensure testability,

reliability, usability, maintainability and performance of the application.

• Contributed to organizational change management by facilitating robust User

Acceptance Testing and supporting the training phase of project and attended higher level

meetings for status updates.

Analyst Software/Tools: IBM Rational Rose, Documentum, MS Project,

Oracle Clinical, Thunderbird, SAS Clinical, Informatica, UNIX, XML, Java Novell Netware, Microsoft

outlook, Toad.

Mayo Clinic, Rochester, MN Jan 2006 – Jul 2007

Project: WellExpert

Role: Sr. Business Analyst

WellExpert is the tool that is developed by the Mayo technical team. Initially was working on the

Tobacco Quitline program which helps the members of the program to help quit the smoking. But now it

comprises of some more programs in it which are Disease Management, Life Style Coaching and in a

smaller amount Pregnancy care and AMC.

The members of the program can be the companies who buy these programs or the individuals who

come to know about this program and enroll themselves in it. Members’ first log onto customized Mayo

Clinic website complete the Health Risk Assessment and gives the consent, based upon the HRA data

and risk criteria that client defines, members are loaded into Wellexpert for calls.

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.

• Work 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.

• Assist with serious adverse event reporting and reconciliation.

• Well versed with FDA CFR 21 Part 56 (Institutional Review Board), as have experience

of Member Secretary.

• Reviewed and maintained functional test case status for Functional Testing of the all

components of this project in Test Director.

• Responsible for higher level meetings for different activities, time lines and deployment to

update and manage Stakeholder expectations.

Analyst Software/Tools: MS Visio, MS Project, MS Word, MS PowerPoint, MS Excel, MS Access,

MS Outlook, Test Director

IDX Systems Corporation, Burlington, VT Feb 2005 – Jan 2006

Project: Cardio Vascular Information Systems (CVIS)

Role: Clinical Business/Data Analyst

Imagecast CVIS, a clinical information system from IDX is cardiology based feature rich application that

will ultimately meet the majority of needs for each member of the clinical and administrative teams in

cardiology department, and will serve this information to users across the enterprise via web access.

Imagecast CVIS is designed to improve access to patient data, optimize specialty and sub specialty

workflow, enhance images and enable information sharing to support patient care.

Responsibilities:

• Responsible for self and BA team’s deliverables like business requirements, Functional

Requirements, Functional specifications and Product Hand Book that have Use Cases, Process

Flows, Sequence Diagrams, and Activity Diagrams .

• Responsible for weekly meetings with Development and QA team to evaluate product

stability, biweekly management meetings for Product development Progress review and training

sessions for business users to demonstrate product functionality after UAT release for all versions

over phased SDLC.

• Maintained the deliverables in MasterControl and Visual SourceSafe in accordance

with FDA standards.

• Ensured compliance to the Rational Unified Process (RUP) methodology.

• Dealt with all the process and technical issues, as well as GCP compliance and

regulatory requirements. Review case report forms and source documents for completeness,

legibility and logic flow.

• Provide evaluability assessments for appropriate case report forms according to the

protocol.

• Code Case Report Form verbatim terms using Pharmanets or client supplied

dictionaries.

• Reviewed the Online Help document prepared by the Documentation team.

• Entered reported data into database platform based on business rules, procedures and

definitions.

• Analyst Software/Tools: RequisitePro, MS Visio, MS Project, MS Word, MS

PowerPoint, MS Excel, MS Access, MS Outlook, Rational Unified Process (RUP)

Bioequivalence Dept, BioArc, Alembic Limited (CRO), India Apr 2004 Jan 2005

Role: Clinical Business/Data Analyst

VLDB Volunteer database management system involves the basic information about the volunteer

coming in for the project, gathers all the details, Screens for the clinical parameters i.e. all laboratory

parameters and finally gives whether the volunteer is fit for the study or not. This Database consists of

information of more than 2000 volunteer all over the Gujarat in India. It was designed for integration with

other operations support systems, such as provisioning, planning, fault management, configuration

management, capacity management, and accounting systems.

Responsibilities:

• Coordinated and conducted all activities related to writing and editing user help manuals

for use in clinical trials.

• Wrote and edited IND sections, clinical protocols, investigator brochures, clinical

study reports, and NDA sections.

• Developed documentation system, including style guides, templates, and naming

conventions.

• Prepared documents for all phases of the SDLC process.

• Involved in all the activities of the IRB/IEC (Institutional Review Board/Independent

Ethics Committee) that works for the welfare of the volunteers.

• Preparation of the SOPs related to IRB, i.e. Formation of the IRB, Management of the

IRB, Functions of the IRB, and Responsibilities of the IRB members, Procedure for the Expedite

approval, Approval of the protocol, ICFs.

• Supervise Updates of the information of the volunteers in the Database time to time.

• Record management and maintenance of the related documents.

• Giving Approval for the studies, primary review of the protocol, ICFs (Informed

Consent Form), Literature regarding the drug.

• Reviewing the Rationale for the study (fed & fasting).

• Closely associated with the development, design and implementation of new

relational or multi dimensional databases for the Volunteers.

• Successfully attained Bioequivalence for important drugs like Loratadine (32

Subjects), Levetiracetam (Fed & Fasting, 18 Subjects) Theophylline 32 Subjects, Pinaverium

(Fed & Fasting), Felodipine (Fed & Fasting), Bupropion 19 subjects, Theophylline Steady State 72

subjects.

• Achieved Canadian Submission Study successfully i.e. Loratadine.biostudy (32

subjects).

• Looked after the finances regarding the study budgeting, subjects compensation.

• Trained on GCP GOOD CLINICAL PRACTICE (based on CFR 21) by ARUN BHATT.

• Trained on IRB/IEC functionality (Based on Schedule –Y, ICMR guideline) by Dr.

Urmilla Thatte.

Analyst Software/Tools: MS Visio, MS Project, MS Office, MS Access.

Ugam Solutions Pvt Ltd., India Nov 2002 – Apr 2004

Role: Business Analyst

FLOW™, innovative, proprietary Software to enhance the delivery of research by clearly indicating

project requirement, state of progress and areas of responsibility. FLOW ™ facilitates sharing of

information across internal and external teams allow centralized document management

Analyst Software/Tools: MS Visio, MS Project, MS Office.

Navayug Vidhyalaya, India Dec 2001 – Nov 2002

Role: Faculty

As a faculty for computer for Grades 9 to 12, I was solely responsible for the results of board students.

Assisted the school authorities with their routine activities related to computers, brought a few

advantageous changes with the execution of computer studies by introducing school to free help

providing associations.

I tech Computers Aug 1999 – Nov 2001

Role: Tester

I joined as tester of 2 software product developed by the Organization. Due to potential and ability to

work with flexibility, I was promoted to Quality Assurance Officer for E Data processing department.

Responsible to check the quality of processed data before sending it back to the client.

Project: Online Ticketing (VISTA)

Role: QA / Junior Analyst

VISTA is ticketing software developed in New Zealand. The aim of this project was the modify VISTA

according to the business requirements in India and rollout the same in cinemas across India. This

enabled the theatres to automate their ticket booking and also allowed customers to call and book their

tickets.

Project: Medical Billing System

Role: Quality Assurance

The product Medical Billing System is for multi location clinic in USA. The WEB based application

manages computerized Clinic and Reporting units billing and claim system. The billing system will

maintain the setup of medical services at different reporting units. Based on this services setup the

client admissions, services activities, progress notes operations will be maintained. Billing will be made

based on the applicable charges for the services provided. The insurance claims based on the billing

will be tracked and maintained. This WEB based application will make billing and insurance claims

monitoring from anywhere. This WEB based billing system along with electronic filing application

system will make overall function of clinic effective and within control.

Analyst Software/Tools: C, C++, MS Word, SQL Server, MS Excel and MS Access.

EDUCATION:

• Dip. in Advanced Computing CDAC Ministry Of Information Technology(Govt. of India)

• Bachelor of Science, Maharaja SayajiRao University, Vadodara, India

• Online certification in Human Participants Protection Education for Research Teams,

sponsored by the National Institutes of Health (NIH),

This course included the following:

Key historical events and current issues that impact guidelines and legislation on

human participant protection in research.

Ethical principles and guidelines that should assist in resolving the ethical issues

inherent in the conduct of research with human participants.

The use of key ethical principles and federal regulations to protect human participants

at various stages in the research process.

A description of guidelines for the protection of special populations in research.

A definition of informed consent and components necessary for a valid consent.

A description of the role of the IRB in the research process.

The roles, responsibilities, and interactions of federal agencies, institutions, and

researchers in conducting research with human participants.

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