Clinical Research Data Management Tester : Resume CV

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Curriculum Vitae :
Ms. Supriya A. Sao.
supriyasao12 AT gmail.com

Current Position :
Cipla Ltd Mumbai, India (2 Years & 3 months)
(Nimbus Infra Services Pvt. Ltd, earlier Fame Corporation) Mumbai, India
Clinical Research Department – Data Management Tester (Manual Testing), Coordinator (6th August, 2008- till date)

Responsibilities as a Tester :
Manual Testing of Data Management Software
Testing Installation Qualification
Testing Operational Qualification
Testing Performance Qualification (Ongoing)
Supervision of the Development of Electronic Data Capture Software.
Review of the study related Data Management Documents.
Training of the personnel on Data Management Software.

Responsibilities (as a Coordinator) :
Active Participation in the development of Data Management Software by Calyx info Pvt. Ltd.
My responsibilities involved :
reviewing the software and informing software developer about the necessities and the modification needed as per the company requirements.

Review of documents for SDLC (Software development life Cycle) including :
- User requirement specification
- Technical design and Architecture
- Navigation Sequence
- 21CFR Part 11Checklist mapping to Calyx info solution
- ICH-GCP Checklist mapping to Calyx info Solution
- GCDMP Checklist mapping to Calyx info solution.
- Software validation checklist
Supervision of screens during the testing phase.
Reconciliation of errors encountered during testing phase.
Preparation of DM SOP’s
Preparation of Test plan
Preparation of Data Validation Plan

Responsibilities (as Sponsor Representative) :
Review of study related Data Management Documents
- Preparation of Case Report Forms of subject participating in clinical trial.

Responsibilities (as Auditor) :
Review of DM software, DM study procedures, and Operational activities.

Education :
M.Sc.Computer Science – University of Nagpur
Year of passing :(2005 -2009)
B.Sc.Computer Science - University of Nagpur
Year of passing :(2002-2005)
Project Done the full fledged Project on Road Tender during M.sc 2nd year (VB.NET)

Computer Skills :
- Proficiency in MS Word , MS Excel& MS PowerPoint
- Well versed in using Internet.

Training Attended :
- Attended 1 day conference on GCP Program organized by Cipla Ltd at Cipla R & D Vikhroli on 21 October 2010.
- Short Course on Fundamentals of “Clinical Data Management” on August 16,2010 to August 20,2010 at Biostatistics Resource and training Center, Christian Medical College,Vellore,India
- Vitalograph Pulmonary Function Testing in Clinical Trials on March 30 , 2009 at RND Vikhroli , Mumbai
- The Introductory Course inGCP for Investigators on June 14 , 2009 at Marigold Premises , Kalyani Nagar , Pune
- Spirometry Workshop on July 24 , 2009 at Marigold Premises , Kalyani Nagar , Pune
- Quality, Ethics and Regulations in Clinical Research on November 29, 2008 at RND Vikhroli , Mumbai

Personal Details :
Date of Birth : 12/12/1984
Mother Tongue : Marathi
Sex : Female
Marital Status : Unmarried
Nationality : Indian

Declaration :
I hereby declare that information provided above is best of my belief and knowledge.

Supriya A. Sao

[Guest]

RENUKA POPAT KUTWAL
E-mail : renukakutwal AT gmail.com

OBJECTIVE :
Intend to build a career with leading corporate with committed & dedicated people, which will help me to explore myself fully and realize my potential. Willing to work as a key player in challenging & creative environment

EDUCATION :
Educational Qualifications:
Degree/ Examination University/ Board name Institute/ College/ School name Duration Specialization /Subjects studied Marks:
Bachelor Of Science (B.sc.) Mumbai University Vikas College 2009-2010 Physics, computer science 60.87 %
Higher Secondary Certificate Maharashtra State Board Vikas College 2006-2007 English, Maths & stats, Physics,Chemistry, Biology (Bot.& Zool.), IT. 47.10%
Secondary School Certificate Maharashtra State Board Navjieevan vidya mandir. 2004-2005 English, Marathi, Hindi,
Mathematics, Science, & Social Sciences. 64.00%

TECHNICAL SKILL SET :
- Tools : Microsoft Excel.
- Operating System : Windows 98/2000/NT/XP.
- Other Skills : MS-Office, Basic application, Internet knowledge.
- Programing languages : C, C++.

EXPERIENCE :
6 month as Data entry operator in 3i infotech. Currently working Cipla company in a clinical research data management as trial Creator, Data Entry Operator, Export Data on Software.

Extra Curricular Activities :
Street Play, Singing, Bad Minton etc.
- Theory &Concepts Data management.
- Excellent problem solving skills and a self starter well organized leadership.
- Takes initiative and works independently or as part of a team.
- Produce good results under pressure and easily meets deadlines.