Data Clinical Research

Parangusan KaliSrinivasarathinam Phone: +91-996**-*****

S2, #19 Anamica Apartments, Shankarlal Jain Street, Mail

ID: **********@*****.***

Nehru Nagar, Chromepet,

Chennai- 600 044

Education

University of Madras

Master of Science (Biochemistry) - 2006 to 2008

University of Madras

Bachelor of Science (Biochemistry) - 2003 to 2006

Summary

. Over 5 years and 6 months of experience working in Clinical Research

. Clinical Research Therapeutic Areas include:

Lymph Node Cancer-Phase III

Follicular Cancer - Phase III

Prostrate Cancer-Phase III

Renal Cancer-Phase III

Non Dialysis Dependant-Chronic Kidney Disease (NDD-CKD)-Phase III

Rheumatoid Arthritis-All 4 Phases

Non-Small Cell Lung Cancer : Phase I

Psoriasis - Phase II

. Skills include:

o Proficient in MS Excel and Certified by MSME (Govt. of India)

o Six Sigma in Heath Care by MSME (Govt. of India)

. Experience in Various Tools.

Oracle Clinical, Solaris Datafax, Oracle Clinical-RDC, Medidata

Rave

Professional Experience

ICON Clinical Research Responsibilities:

Clinical Data Coordinator II Independently and accurately review Case Report

February 2015 to Till date Form data for completeness, accuracy and

consistency in accordance with all applicable

procedures.

Accurately and consistently apply data handling

conventions to Case Report Forms as necessary in

accordance with all applicable procedures.

Performed Quality Reviews and appropriately

address all issues.

As a point of contact, compiled and distributed

necessary study documentation and maintain

accurate and complete study files in accordance

with all applicable procedures. Identify and

appropriately address data discrepancies in the

clinical data via computerized edits and manual

checks/listings. Independently and accurately

generate data queries to resolve data

discrepancies. Appropriately address responses to

data queries and accurately update the clinical

data as necessary. Identify and accurately resolve

all workflow or clinical data discrepant issues.

Independently and accurately prepare database test

documentation and test data entry screens.

Assisted with the validation of edit check

programs. Assist with the development, review and

the update of relevant Data Management Study

Specific Procedures.

Accurately performed Serious Adverse Event

reconciliation in accordance with all applicable

procedures.

Accurately performed external data reconciliation

in accordance with all applicable procedures.

Generate, review for accuracy and distribute

status reports as requested. Assume study lead

role when applicable. Represent Data Management at

internal / external meetings as appropriate.

Effectively mentored less experienced staff and

performed project management. This may include

assisting and guiding new personnel during their

initial training period.

Cognizant Technology Responsibilities:

Solutions India Pvt. Ltd Implement and promote the use of consistent,

Data Analyst efficient quality processes to meet timelines and

March 2014 to January 2015 deliverables for the project teams

Review and action queries on an ongoing basis and

update database appropriately.

Develop eCRF Review Manual and eCRF Instructions

(for EDC studies).

Develop CRF Review Manual and Instructions for the

Investigator (for paper studies).

Review EDC Core Configuration against study

requirements and assess need for any amendments.

Develop mock CRF, Unique CRF casebook and

annotated CRF.

Create and maintain CRF data standard document

Create and maintain Data Entry Instructions

Perform UAT according to Validation Plan for

applicable Data Management systems.

Maintain Data Management related operational data

flows.

Review reports and take actions as defined in the

DMP or eCRF review manual

Provide listings for review to study teams as

defined in the DMP and process discrepancies

appropriately

Perform ongoing and final consistency checks,

review protocol deviation and data listings as

defined in the DMP and eCRF Review Manual

Perform updates post database lock if any

Perform SAE Reconciliation between the Safety and

Clinical study databases with supporting

documentation. Issue queries for data points that

exhibit unacceptable discrepancies as appropriate.

Produce safety data listings for safety

surveillance and other data listings as

appropriate

Provide documents to be filed in the Study Master

File

Support Quality control checks for the trial

Ensure that all Data Management activities are

conducted in compliance with relevant regulatory

requirements

Participate in the QC activities (Peer QC ) for

the Junior staff who are in OJT or Mentoring phase

Participate in knowledge sharing sessions as an

when applicable

Ensure adherence to Cognizant and Client SOPs

Ensure timely submission of timesheets/ functional

tracking spreadsheets

Turnaround time to be achieved for the tasks that

impact the milestone delivery.

Excellent Communication skill with the Team and

Client.

ICON Clinical Research Responsibilities:

Clinical Data Coordinator I Independently and accurately review Case Report

August 2012 to March 2014 Form data for completeness, accuracy and

consistency in accordance with all applicable

procedures.

Accurately and consistently apply data handling

conventions to Case Report Forms as necessary in

accordance with all applicable procedures.

Performed Quality Reviews and appropriately

address all issues.

As a point of contact, compiled and distributed

necessary study documentation and maintain

accurate and complete study files in accordance

with all applicable procedures. Identify and

appropriately address data discrepancies in the

clinical data via computerized edits and manual

checks/listings. Independently and accurately

generate data queries to resolve data

discrepancies. Appropriately address responses to

data queries and accurately update the clinical

data as necessary. Identify and accurately resolve

all workflow or clinical data discrepant issues.

Independently and accurately prepare database test

documentation and test data entry screens.

Assisted with the validation of edit check

programs. Assist with the development, review and

the update of relevant Data Management Study

Specific Procedures.

Accurately performed Serious Adverse Event

reconciliation in accordance with all applicable

procedures.

Accurately performed external data reconciliation

in accordance with all applicable procedures.

Generate, review for accuracy and distribute

status reports as requested. Assume study lead

role when applicable. Represent Data Management at

internal / external meetings as appropriate.

Effectively mentored less experienced staff and

performed project management. This may include

assisting and guiding new personnel during their

initial training period.

ICON Clinical Research Responsibilities:

Asst. Clinical Data Accurately review Case report form data for

coordinator completeness, accuracy and consistency in

May 2010 to August 2012 accordance with all applicable.

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 review 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.

Accenture Services Pvt. Ltd. Responsibilities:

Clinical Data Validation Data Validation.

Associate Standard patient tracking,

Aug 2009 to May 2010 Missing pages report, CRA communication tracker

maintenance

Personal Details

Date of Birth : 29th June 1985

Age : 29 Years

Sex : Male

Marital Status : Married

Spouse Name : Mrs. Anusya

Father's Name : K V Srinivasa Rathnam

Mother's Name : S Vyjayanthi

Occupation : House wife

Blood Group : A1+

Passport No. : G5564869

Languages: English (Verbal and Written), Hindi (Verbal and

Written) & Tamil (Verbal)

I hereby declare that the details above furnished are true to the best

of my knowledge.

K S

Parangusan

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