GAYATHRI THOMALA

Mobile: +91-988******* Email: acat17@r.postjobfree.com

OBJECTIVE

Aiming to be associated with an esteemed organisation where I can utilize my skills and can contribute

my best towards the organization objectives and to grow in the organization with smart work and

dedication by utilizing my knowledge and skills.

Employment History

Employer/Designation/ Roles & Responsibilities

From – To

• Visit Vendors to perform Audits and Perform Site audits as per

Manipal AcuNova Pvt Ltd

requirement.

Quality Assurance Associate

• Visit clients with Busniness Development Team.

July 2011 till date

• Conducting Internal Audits for Clinical Operations (TMF

General & Site Specific), Clinical Data Management ( CRF &

Database Audits), Biostatistics & Medical Writing.

• Preparation for external/third party audits.

• Preparation for Certificate audits like ISO 9001:2008, ISO

27001:2005.

• Quality Review of Clinical Study Protocols, Statistical

Reports, Clinical Study Report for Clinical Trials, BA/BE,

Informed Consent Form, Regulatory Dossier.

• Implementation and continuous maintenance of QA system

with written Standard Operating Procedures (SOPs).

• Maintaining the Hard copies as well as Electronic copies of

the SOPs.

• Training and Compliance to the SOPs.

• Auditing of Personal Training Records Periodically for the

compliance and completeness with respect to SOP

• Sharing of document as per the requirement w ith Site,

Manipal AcuNova Pvt Ltd

Project Associate Sponsor, Regulatory and CRA

Mar 2010 – Jul 2011 • Communication with site staff.

• Updation & Maintenance of TMF, Site specific and General

file.

• Updating project tracker on receipt of documents.

• Scanning & uploading documents into shared drive.

• Transmission of documentation into project files.

• QC of documents on receipt and escalation to proper

persons about discrepancies

• Feasibility and start up activities

• QC, Updation and Maintenance of Investigator database.

• Assisting in preparation of Regulatory, EC dossier

• Co-ordinating arrangements for the Investigator Meeting

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GAYATHRI THOMALA

Mobile: +91-988******* Email: acat17@r.postjobfree.com

• Providing support to the CRA during preparation for before

& completion of follow up activities after site visits (Site

selection, Site Initiation, Site monitoring & Closeout)

• Facilitate query resolutions by interacting with DM under

the guidance of the CRA

• Review of the ICF for comp;iance to regulatory

requiremnet.

• Assisting sites/CRA for timely reporting of SAEs to

Sponsor/EC.

• Translation and Backtranslation of ICFs ontime with

appropriate maintainence of tracking system.

• Co-ordinated with the sites for Submission of documents to

EC and compliance, adherance to the Protocol, as well as

to ICH-GCP and local Regulatory Requirements

• Maintaining and updating the Trial IP Shipments in co-

ordination with the sites as well as with the help of the

Sponsor.

• Assisting the MW Team during the preparation of the CSR.

Therapeutic areas of expertise Phase

(Phase II and III trials):

Acute Myocardial Ischemia I/II

Critical Limb Ischemia I/II & II/III

Cerebral Stroke I/II

Chronic Obstructive Pulmonary II/III

Disease

Osteoarthritis of the Knee II/III

Ocular Hypertension III

PROFESSIONAL ACHEIVEMENTS

• Successfully assisted various departments in facing external/Sponsor audits.

• Significant increase in compliance levels on SOPs by the team members.

• Coordinated with higher management for facing audits conducted by various accreditating

agencies.

• Appreciated by the External Auditors for the smooth flow of the Audit and timely completion of the

audit procedures due to good documentation Process.

• Faced several internal and external audits with no major findings.

• Handled maintanance of trial files and QC of trial related documents for 5 clinical trials.

• Added around 500 Investigators across all theraupetic areas in the investigator database.

• Assisted the Clinical Study Report preparation team for 3 studies including the review of the

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GAYATHRI THOMALA

Mobile: +91-988******* Email: acat17@r.postjobfree.com

contents.

• Has got appreciation from the Project Manager and Head of Operations for successfully resolving

pending issues by adhering to the strict timelines so that the database lock of the Studies are

performed on time.

PROJECTS EXECUTED

Pharmacovigilance in Clinical trials (Post Graduate Certificate in CRCDM)

Project was completed under the guidance of Dr. Ramanad S Nadig.

Synopsis: Importance and significance of Pharmacovigilance in the clinical trials.

Computer Aided Drug Discovery for Nasopharyngeal Cancer (M.Sc. Bioinformatics)

Project was completed at SUCAB center, University of Agricultural Sciences, Bangalore under the

guidance of Prof. M.S. Yatnatti.

Synopsis: The project aims at demonstrating the high performance computing and networking (HPCN)

based on computer assisted Drug design with special reference to the occurrence of nasopharyngeal

Cancer.

Neurological Disorders in HIV/AIDS Patients (M.Sc. Microbiology)

Project was completed at Y.R.G. Care, Chennai under the guidance of Dr. P. Balakrishnan.

Synopsis: The study population included 100 HIV +ve patients. The study mainly involves the

opportunistic infections caused by Toxoplasma and Cryptococcus.

ACADEMIC QUALIFIACTION

Year University/College Qualifications

2007 University of Pune Post Graduate Certificate in

Clinical Research and Clinical

Data Management

2007 University of Madras M.Sc (Microbiology)

2006 Sikkim Manipal University M.Sc (Bioinformatics)

1999 Sri Krishna Devaraya B.Sc (Microbiology, Chemistry,

University, Anantapur Botany)

ADDITIONAL QUALIFICATION

• Advanced Diploma in Bioinformatics IT Programming and Cheminformatics (Aug 2006 - Jan

2007)

• Diploma course in Software Technology from CMC-Kurnool (1996 -1998)

TRAININGS/SEMINARS/CONFERENCES

• Sucessfully completed the NIH Extramural Research web based Training Course : Protecting

Human Research Participants”.

• Sucessfully completed the NIDA clinical trials GCP Test by NIH on 10 Sep 2013

• Sucessfully completed the in-house GCP Test conducted by Ecron Aciunova

• Trained on ICH-GCP Guidelines.

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GAYATHRI THOMALA

Mobile: +91-988******* Email: acat17@r.postjobfree.com

• Participated in the 4th Pharmacovigilance Conference “New Insights into Current

Pharmacovigilance Challenges” on March 8-9, 2013 at Taj Vivanta, Bangalore held by DIA.

• Attended one day National Symposium on Pharmacovigilance held on 16 Feb 2013 at Bangalore.

• Attended one day conference conducted by YRG Care – The YRG Care Bioethics Symposium – 06

Jan 2013.

• Attended a three day conference of Fourth National Bioethics Conference conducted by Indian

Journal of Medical Ethics, Council for Social Development & University of Hyderabad- 06 Dec

2012 to 08 Dec 2012.

• Attended a Two day conference on Practical Solutions to Challenges in Research Ethics: A focus

on Human Research Program – 03 Nov 2012 to 04 Nov 2012.

• Advanced Monitoring by Dr. Radhika Boppa at Manipal AcuNova on 06 May 2010.

• Seminar on Applied Bioinformatics at Vittal Mallya Scientific Research Foundation on 15 Jul

2006.

• CME Program on Uncommon Agents of Disease at Madras Medical Mission on 30 Sep 2000.

• CME Program on Uncommon Agents of Disease Part II at Madras Medical Mission on 02 Feb

2002.

• Successfully completed the training in Immunology in the Department of Microbiology for a period

of one Month at the Nizams Institute of Medical Sciences, Hyderabad (01 Nov 2001 to 30 Nov

2001).

PERSONAL SKILLS:

• Excellent verbal and written communication skills.

• Ability to lead the team and willingness to learn.

• Capable to work in a team, and manage stress, time and people effectively.

• Problem solving ability.

• Ready to relocate and work at flexible timing.

PERSONAL INFORMATION

Date of Birth 21 Jun 1979

Sex Female

Marital status Married

Language Known English, Hindi, Tamil, Telugu (Fluent)

Address A-5, Pioneer Plaza, 1stA Cross, S.R.Layout, Wind tunnel Road,

Murugeshpalya, Bangalore-560017.

REFERENCES:

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GAYATHRI THOMALA

Mobile: +91-988******* Email: acat17@r.postjobfree.com

1. Dr. Ramanand Nadig

CEO, Khodays Stem Cell Research, Bangalore

Mobile: +919*********

2. Kiran MJ

Team Lead,

Ecron Acunova

+919*********

DECLARATION:

I hereby declare that the above written particulars are true to the best of my knowledge and

belief.

Place: Bangalore

GAYATHRI.THOMALA

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