Resume for the post of Data Manager in Clinical Data Managements Department. I am having more than 7 years of experience and looking forward for a job opportunity in the Delhi-NCR or for home based job. Madhavi Kaushal Mob. No:+91-8447133946.

1. Madhavi kaushal
madhavikaushal09@gmail.com
C-44, C BLOCK, First Floor, East of Kailash, New Delhi-110065
+91- 8447133946, +91- 9811341644
Page 1 of 2
OBJECTIVE _____________________________
 To be a part of Organization where I can learn, utilize my skills and get Performance based Growth.
PROFESSIONAL EXPERIENCE _____________________________
From Jun’14 to till
Date
 Position: Data Manager (Clinical Data Management)
 Organization: JSS Medical Research India Ltd, Faridabad. ( formerly known as Max Neeman
International, New Delhi)
From May 2012 to Jun
2014
 Position: Validation Associate (Clinical Data Management)
 Organization : Max Neeman International, New Delhi (JSS Medical Research India)
From jun’06 to feb’09
 Position: QC Executive (Microbiologist)
 Organization: Piramal Health Care , Pithampur, Disst-Dhar (M.P)
From Oct’05 to jun’06  Position: Q.A officer (Q.A Micro Validation Department)
 Organization Claries Life Sciences Limited, Ahmadabad (Gujarat)
Job Description _____________________________
 Managing 7 studies at a time at various stages (i.e. .Development, Production and Analysis phase) successfully.
 Responsible for creation of DMP (Data Management Plan), Data Validation Specifications, Data Entry Guidelines, CRF
Completion Guidelines, Case Report Forms while applying regulatory guidelines, standard operating procedures, and
protocol requirements.
 Responsible for training and supervision of study team for database development, Query Management & database
lock and analysis plan preparation as per the protocol requirement.
 Review the process of database Designing, development and testing which includes Annotation list, Edit Checks
Specifications and testing documents review for both Paper and EDC studies as per the protocol requirement .
 Review the process of Data Cleaning/Discrepancy Management of paper-based and EDC projects according to the
SOPs to ensure compliance with the study protocol.
 Handled data collection, ensuring accuracy and consistency of clinical data and data review to ensure compliance
with internal and external guidelines and protocol. Resolved data discrepancy and related issues by interacting with
respective teams.
 Responsible for implementation of database lock related process and documentation of all DM activities.
 Responsible for development and management of Data Management related documents as per the sponsor and
regulatory requirement.
 Assisting in updating standard operational procedures to ensure compliance with regulatory guidelines and overall
clinical objectives
Summary of Skills _____________________________
 A good understanding of Clinical Data Management tasks with ability to evaluate the information in relation to the key
project processes
 Capable of handling a wide range of activities, including CRF designs, database management, ensuring validation
programming to create quality data plans, database lock related activities and preparation and handling of DM
documents
 Familiar with various software packages crucial in clinical data management.

2. Madhavi kaushal
madhavikaushal09@gmail.com
C-44, C BLOCK, First Floor, East of Kailash, New Delhi-110065
+91- 8447133946, +91- 9811341644
Page 2 of 2
 Ability to lead the team in coordinating project tasks, maintaining updated clinical databases and assisting to prepare
accurate case report forms
 Adept in keeping records, maintaining up-to-date data entries, and overseeing the project progress
 Team player with managerial, and communication skills
EXPERIENCE IN THERAPEUTIC AREA ____________________________
 Cardiology phase III and IV
 Oncology trial : Phase I
 Endocrine trial: Phase I
 Gastrointestinal trial: Phase III
 Arthritis: Phase IV
 Device studies
ACADEMIC BACKGROUND_____________________________
2011-2012
POST GRADUATE DIPLOMA IN
CLINICAL RESEARCH (PGDCR)
Post Graduate Diploma in Clinical Research from RNIS College of Clinical Research &
Allied Sciences, New Delhi.
2002-2004
M.Sc.( microbiology)
Institute of Environment Management and Plant Sciences, Vikram University Ujjain. (M.P)
1999-2002
B.Sc.( microbiology)
P.M.B. Gujarati Science College, Devi Ahilya Vishwavidhyalaya, Indore (M.P.)
ACHIEVEMENTS _____________________________
 M.P FDA Approved chemist.
 Got the best customer award & Star award (JSS Medical Research India Ltd) for getting repeat business from the
existing client and delivering quality work within time line.
 Got appreciation letters in Piramal Health Care for initiation of the validation of the ANDA products.
 Faced USFDA cGMP inspections and other Domestic inspections
 N.C.C. ‘B’ certificate
PERSONAL DETAILS _____________________________
Marital Status Married.
Language Known English, Hindi.
(MADHAVI KAUSHAL)
Date:
Place: New Delhi