Clinical Research Data Analyst

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CURRICULUM VITAE

My Contact Information: -

Name: Sneha Valsarajan

Permanent Address:

Current Address:

Snehanubhavam House, Orayil Valiyannur, Post Varam, Kannur-670594, Kerala Room 404, Vijayaanand Park 2A, Manvel Pada Road, Virar (E)-401303, Maharashtra Cell Phone No.: 996-***-****/ 981-***-****

E-Mail ID: *****.**********@*****.***

Date of Birth: 4th April 1988

Relevant Employment History: -

Organization Designation Duration

Cognizant Technology Solutions

Junior Data Analyst – Business Process

Associate

June 2016 to June 2017

Role & Responsibilities:

• Data Validation (CRF entry, Third Party Data Review)

• Discrepancy Management (RAVE®, Discman (CTS tool for discrepancy management))

• Query Management

Organization Designation Duration

R S Serve (Freelance/Contract) Senior Executive – CRA (Monitoring) Dec 2014 to June 2016 Role & Responsibilities:

• To conduct site visit prior study initiation to ensure that all aspects of the study are understood by the investigator and staff. If required train the study site team

• To confirm the appropriateness of the site for the study in all aspects and ensure that all documentation required initiating the study is complete

• Monitor study progress to assure compliance with protocol requirements, regulatory requirements and Good Clinical Practice by conducting site visits as directed by the Sponsor

• Perform site monitoring visits to include review of source document, case report form, ICD, Patient Diary, Investigator Site Binder, other documents as applicable Organization Designation Duration

Panexcel Clinical Lab Private Limited Executive – RA (Medical Writing) Jul 2011 to Nov 2014 Role & Responsibilities:

• Prepared more than 100 study protocols as per Sponsor/Regulatory requirements in consultation with Principal Investigator and other investigators using protocols synopsis provided by the sponsor, relevant information provided by statistical and bioanalytical department

• Carried out literature search and prepared drug information and/or product information

• Prepared Informed Consent Forms (ICFs) and CRFs as per protocol requirement

• Communicated with Ethics Committee for project application, study schedule notification, intermediate CSR submission and final report submission

• Prepared and compiled approximately more than 6 study report for USFDA submission format (E-CTD format), few TGA submission and more than 100 CSR for DCG(I) submissions

• Prepared the Regulatory dossier (for BE NOC and Test License) as per regulatory requirement Page 2 of 2

Academic qualifications: -

Sr. No. Qualification University/Board Year Place

1. P.G. Diploma in “Advanced Clinical Research” Institute Of Clinical Research 2009 Mumbai 2. T.Y.B.Sc Maharashtra Board 2008 Mumbai

3. H.S.C Maharashtra Board 2005 Mumbai

4. S.S.C Maharashtra Board 2003 Mumbai

Details of Training/Workshop Attended: -

Month and Year Topic Conducted by Conducted at

June – 16 Data Management Skills (LDMS)

Multiple Trainers

Cognizant Technology Solutions

CTS

Mumbai, India

April – 14

eCTD Submission

Hands-on One-day Training

Program

Ralf-Peter Berg

Director - Education & Services

(EXTEDO)

DIA

Scitech Center,

Mumbai, India

Aug -12 to May-

13

ICH-GCP Training

Multiple Trainers

Panexcel Clinical Lab Private Limited

PCLPL Navi Mumbai

May-09

30hrs Orientation Program in

Statistical Analytical System

Dr. S.K. Gupta

(Dean & Director General, ICRI)

ICRI Mumbai

Feb-09

FDA Smart Inc. Program –

“Understanding FDA and the

FDA Approval Process”

Dr. Joshua Sharlin

(Former US FDA reviewer (USA))

ICRI Mumbai

Professional Achievements: -

• Successfully handled regulatory inspection by MOH Turkey, US FDA & Sponsor’s Audit, DCGI.

• GDUFA self-identification for the company at Panexcel Clinical Lab Private Limited. Declaration: -

I undersigned, certify that to the best of my knowledge, this CV correctly describes my qualification, my experience. I understand that any willful misstatement in this CV may lead to my disqualification or dismissal, if engaged Place and Date: -

Signature: -

Sneha Valsarajan

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