Data Manager

Revathi

Email ID: abnym4@r.postjobfree.com

Contact No: 469-***-****

CAREER

OBJECTIVE

Seeking a stimulating growth oriented and a quality environment where my

knowledge and experience can be shared and enriched for the development of

the organizational goals.

EDUCATION

PES College of

Pharmacy (2009-2012)

Master of Pharmacy

(Pharmacology)

Siddaganga College of

pharmacy (2003-2007)

Bachelor of

Pharmacy

SUMMARY

. Over 3 Year of experience working in clinical research.

. Independently and proactively perform all clinical data cleaning

activities on assigned projects.

. Thorough understanding of Clinical data management process.

. Trained and worked Clinical Data Management systems Oracle Clinical

(OC), Oracle Clinical-RDC (OC-RDC), Inform 4.3, MedidataRave.

. CRF review for completeness, accuracy and consistency.

. Thorough knowledge of data validation processes (Identify

discrepancies in Clinical Data - edit and manual checks/Listings,

Discrepancy review, Query management - Review & Resolution) along with

Due diligence process.

. Good understanding of International Conference of Harmonization/Good

Clinical Practice (ICH GCP) Guideline, FDA and CDISC guidelines.

. Good Knowledge of 21 CFR Part 11, Good Clinical Data Management

Practice (GCDMP).

. Understanding of CDM SOP's.

. Effective communication skills.

. Have working experience in different Clinical Research Therapeutic

Areas include: Renal Transplantation study, Nervous system Disorder

(Parkinson's disease), COPD (Bronchial Asthma), Vaccines and

Infectious diseases.

Skills:

. Systems/Computer skills include: Windows XP, Windows 7, MS Office,

Oracle Clinical (4.5.3) and OptICON

. Experience in Electronic Data Capture trials: OC RDC,Inform

. Languages Known : English, Telugu, Hindi & kannada

Professional Experience

ICON Clinical Research (Aug-2011 to July-201

Clinical Data Coordinator

Responsibilities:

. Accurately review Case Report Form date for completeness, accuracy and

consistency in accordance with all applicable procedures.

. Identify and appropriately address data discrepancies in the clinical

data via computerized edits and manual checks/listings.

. Performing Due diligence activities

. Accurately generate data queries to resolve data discrepancies.

Appropriately address responses to data queries and accurately update

the clinical data as necessary.

. Accurately and consistently apply data handling conventions to Case

Report Forms as necessary in accordance with all applicable

procedures.

. Perform Quality Reviews and appropriately identify all issues. Compile

and distribute necessary study documentation and maintain accurate and

complete study files in accordance with all applicable procedures.

. Perform other duties reasonably related to the position as directed by

manager/designee.

Quintiles (Feb 2011-July2011):

Assistant Clinical Data Coordinator

Responsibilities:

. Accurately review Case Report Form date for completeness, accuracy and

consistency in accordance with all applicable procedures.

. Identify and appropriately address data discrepancies in the clinical

data via computerized edits and manual checks/listings.

. Accurately generate data queries to resolve data discrepancies.

Appropriately address responses to data queries and accurately update

the clinical data as necessary.

. Accurately and consistently apply data handling conventions to Case

Report Forms as necessary in accordance with all applicable

procedures.

. Perform Quality Reviews and appropriately identify all issues. Compile

and distribute necessary study documentation and maintain accurate and

complete study files in accordance with all applicable procedures.

. Perform other duties reasonably related to the position as directed by

manager/designee.

BGS Global hospitals (June 2010-Dec2010):

. Monitored all the Adverse events as a part of project work

. Reviewing all the Case Reports forms and Identifying the cause of AEs

. Drug-Drug interactions reporting.

. Worked with the departments ( General Medicine,Diabetology)

Connextious (Jan2008-Mar2009):

Pre-clinical Research Scientist:

Responsibilities:

. Monitoring animals used for studies including their feed and

temperature maintenance of room temperatures

. Handlings animals like Albino rats,Wistar rats,Rabbits,Guinea pigs,

mice

. Participated in studies like Depression activity on mice using herbal

drugs

. Anti-ulcer activity on rats and rabbits using herbal drugs

. Anti urolithiatic activity on Rats using herbal drugs

CDM:

- Edit Checks Specifications

- Pre-Entry Review of CRFs

- Double Data Entry Process

- Manual Review CRFs

- Discrepancy Management and Query generation.

OTHER ACTIVITIES:

. Appreciation certificates from ICON for the activities conducted in

office.

. Participated in International conference poster presentations.

. Event organizer in college Annual day functions.

. Worked as volunteer in blood-camp conducted in our college.

. Project in M.Pharm: Antiulcer activity of Aqueous and Alcoholic

extracts of Medicago Sativa (Alfalfa) on Albino rats.

Areas of interest:

. Pharmacovigilance

. Medical writing

. Regulatory Affairs

. Medical coding

Declaration

I declare that all the above-furnished details are true to the best of my

knowledge. I assure that I shall strive to be a successful professional in

your concern, fulfilling all my responsibilities towards meeting the

organizational objectives.

Revathi

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