VAISHALI ACHAREKAR

Email: abni9v@r.postjobfree.com

Phone: +91[0] 977-***-****

[pic]Key Competencies & Skills

Leadership, Process Management, People Management and Risk Management with

Data Analysis, I.T. efficiency, Communication.

TECHNICAL PROFICIENCY

FRONTENT/GUI : VB 6.0

DATABASE : MS-Access, Oracle Clinical, InForm, OC/RDC

PROGRAMMING LANGUAGE : C, C++, SQL, PL/SQL, COBOL, SAS

OPERATING SYSTEM : MS-DOS, UNIX, Windows 2000,

Windows 95/98

APPLICATION PROGRAMS : MS-OFFICE, LOTUS NOTES, COREL 8,

Nugenesis, InForm.

EDUCATIONAL QUALIFICATION

o SECONDARY SCHOOL CERTIFICATE EXAMINATION (S.S.C) - 1996

M.H.HIGH SCHOOL, THANE (MUMBAI UNIVERSITY)

72.80%

o HIGHER SECONDARY CERTIFICATE EXAMINATION (H.S.C) - 1998

M.H.Jr.COLLEGE, THANE (MUMBAI UNIVERSITY)

69.17%

o BACHELOR OF COMPUTER SCIENCE(B.C.S ) - 2001

R.Y.K.SCIENCE COLLEGE, NASIK (PUNE UNIVERSITY)

50.08%

Training / Continuing Education Summary

Program or Course Coverage

SIX Sigma [Structured Root cause Analysis, 5 WHY

Problem Solving] analysis, Fish bone Analysis,

Pareto Analysis - all as the SIX

Sigma standards.

Involved in the green belt project

initiated to reduce the cost per

project

Unified Project Plan To design a UPP as per ISO

Training standards and to Standardize a

process flow.

WORK EXPERIENCE

. EMPLOYER : WELLQUEST CLINICAL RESEARCH CENTRE

(NICHOLAS

PIRAMAL)

TITLE : DOCUMENTATION MANAGER

DATE OF EMPLOYEMENT : DEC, 03 - DEC, 04

RESPONSIBILITIES

o Responsible for preparation and revision of the SOPs related to

data management.

o Preparation of control documents (e.g. Protocols, ICFs, CRFs)

o Formatting and compilation of Final report for dispatch to the

clients.

. EMPLOYER : ACE BIOMED Pvt. Ltd. (International

Division)

(CLINICAL RESEARCH ORGANIZATION)

TITLE : DOCUMENTATION OFFICER (Data

Management)

DATE OF EMPLOYEMENT : JAN, 05 - JUL, 07

RESPONSIBILITIES

o Deliver relevant trainings to the team members

o Resource management

o Preparing, revising and authorizing all data management related

SOPs. Maintaining soft copies of all controlled documents in the

organization

o Preparing computer generated bioequivalence study reports and other

technical documents (Protocol, CRFs, ICFs). Compilation of Final

report with all the raw data created in the bioequivalence study

for clients.

o Controlling and maintaining the data using SDMS (Nugenesis

software). Assisting IT person for modeling the database for the

organizational study data according to the categories of study data

and departmental access to the data.

EMPLOYER : TATA CONSULTANCY SERVICES, MUMBAI

(CLINICAL DATA MANAGEMENT)

TITLE : PROCESS EXECUTIVE

DATE OF EMPLOYEMENT : AUG, 07 - JUL, 08

RESPONSIBILITIES

o Knowledgeable about the eCRF development processs (InForm and

SAS). Worked with study team to identify and resolve eCRF and

dataset inconsistencies to provide high quality services.

o To provide quality control services through test script creation

execution and documentation testing scenarios mentioned in DVS for

validation rules developed in Inform in the support of eCRF

development activity.

o Data validation test script creation, Data validation test script

execution, Validation of the data set creation process for testing

of developed SAS programs with corporate quality standards,

SOPs/Guidelines, ICH-GCP and/or other international regulatory

requirements.

o Responsible testing of data extraction process developed for eCRF

Inform oracle tables to SAS views with supporting dataset

specification tools.

o Provide the quality control services for the MedDRA coded items

involved in eCRF (Inform forms).

o To provide timely feedback to internal and client study team

contact on inefficient or ineffectual processes as identified.

TITLE : SUBJECT MATTER EXPERT &

TRAINER

DATE OF EMPLOYEMENT : AUG, 08 - JAN, 10

RESPONSIBILITIES

o Responsible for preparing, updating training material and

conducting trainings for tools and QC processes involved in eCRF

development.

o Responsible for mentoring to team members for all the eCRF testing

activities and updation in the process. Also provide the support

all team member for allocating studies efficiently.

o Contact client side SMC for QC process related updation and

approval process.

o Part system Registry group for performance testing of new

tools and updated versions of applications envolved in the

eCRF development process.

TITLE : TEAM LEADER (Programming

Team)

DATE OF EMPLOYEMENT : FEB, 10 -TILL DATE

RESPONSIBILITIES

o To deliver relevant training to the team as per the requirement of

the project.

o To coordinate the workload, prioritize and manage staff as per the

workload forecast on a project.

o To be a one point contact for the client staff and Managers

o To ensure that the timelines of all the deliverables are met,

keeping quality as a priority.

o Resource Management

o Leave management

o Recruitment

o Present Metrics/Work Load forecast to the client

o Attend regular teleconference with the Client staff and management

and communicate and address any study related issues or concerns.

o Mentoring Team progress and Updating Organization Structure (in

case of any Change)

o To be prepared for the client audits and prepares the team members

for the same.

o Provide annual performance appraisals of direct reports and

provide regular feedback, if applicable to Operation Manager

(During Appraisal / whenever asked for).

PRODUCTION DUTIES:

o Performing testing for Data Validation check created in InForm and

SAS as a part of study designing.

o Performing User Acceptance testing for Coded items in the InForm

o Perform database testing by creating listings of oracle datasets

using SAS system.

o To work on the study related issues and resolve them as SMC. Roll

out the information within team.

EMPLOYER : COGNIZANT TECHNOLOGY SOLUTION, MUMBAI

TITLE : Database Developer

DATE OF EMPLOYEMENT : Jul, 11 - Till date

o Generates and maintains all required documentation, including the

development of specifications, coding, and validation efforts in

support of annotated CRFs, database creation, coding setup, edit

check procedures, import setup and processing, export setup and

processing, listings in Oracle clinical. Review and maintain

global standards related documents.

o Serves on project teams to coordinate and lead development

activities for clinical programming projects.

o Attends meetings, participates in discussions, uses an analytical

approach to problem solving, focuses on deliverables, and provides

constructive criticism. Keeps those responsible for project

management informed of any issues that might impact project target

dates, and escalates potential problems effectively and in a

timely manner. Balances multiple task assignments and communicates

needs to supervisor to obtain needed resources.

o Assists in sponsor audits.

o Conduct trainings for process of study set up activities in Oracle

Clinical.

ACHIVEMENTS:

. Attended 'Train the Trainer' Program at Philadelphia, USA at client

site.

. Awarded with 'Star of the month' title for the month of October

2008.

. Created testing tools scripted in EXCEL macro to automate the test

script creation process in eCRF development process. Also working

for automating whole task of test script execution of

eCRFs(Inform).

PERSONAL DETAILS

NAME : VAISHALI P. ACHAREKAR

ADDRESS : 202/Panchashil Apartment, Mumbai -Pune Road,

Kalwa Thane

BIRTH_DATE : 9TH OCTOBER 1980

Passport Details

Name as on Relationshi Passport Date of Expiry Place of

passport p Number Issue Date Issue

Vaishali Acharekar Self G9748280 11-Jul-08 11-Jul-18 Mumbai

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