Data Entry, document control, QC, audit of QCI
Resume:
CURRICULUM VITAE
Name: Arunava Datta Choudhury Email:*******.************@*****.**.**
Village: Berimura
Post Office: Bamutia
Police Station: Lefunga
District: Tripura West
Pin Number: 799211
State: Tripura
Country: India
Mobile Number: 819-***-****, 998*******
Objective: A Leadership position where my Knowledge can be best utilized to optimize the Organizational needs. To excel in whatever I step in achieve to the best of ability through my sincerity, dedication and hard work, diplomatically live up to the best of my life, seeking a position to utilize my skills and ability in an organization that offers me professional growth while being resourceful, innovative and flexible,
Work Experience: Overall experiences of 9 years 11 months in Clinical Data Management in Quintiles Research India at Bangalore.
Worked as Clinical Data Assistant 2 in Quintiles Technologies (India) Pvt. Ltd. Current Data Management activities comprises of Indexing, Indexing QC, Indexing clarification, Importing & Exporting of study data documents, Fortis Validation, Data Tracking Guidelines review, Data Entry, Data Review, Quality Control & Document preprocessing activities like Scanning, Counting, Sorting, Reconciliation, Filing, Tracking, Acknowledgment, etc.
Date of Employment: 04/2013 – 03/2016.
Job Title: Clinical Data Assistant 2
Key Responsibilities:
• Back up Data Entry lead.
• Team Leader of Indexing Associate, Scanning Associate, File room Associate.
• Team Leader of Processing and tracking of clinical study documents in accordance with Data Tracking and Data Entry Guidelines.
• Team leader in review activity of data tracking guidelines.
• Team leader of Fortis validation activities.
• Process and enter data accurately and in a timely manner in accordance with CRF Tracking and Data Entry Guidelines.
• Meet objectives as assigned.
Date of Employment: 11/2008 - 03/2013.
Job Title: Clinical Data Assistant 1
Key Responsibilities:
• Perform the role of Data Entry Associate.
• Team Leader of Indexing Associate, Scanning Associate, File room Associate.
• Lead performer of Processing and tracking of clinical study documents in accordance with Data Tracking and Data Entry Guidelines.
• Lead performer in review activity of data tracking guidelines.
• Lead performer of Fortis validation activities.
• Process and enter data accurately and in a timely manner in accordance with CRF Tracking and Data Entry Guidelines.
• Lead performer of archiving activity of study data documents to sponsor.
• Understand and comply with core operating procedures and working instructions.
• Leader in maintenance of Data Management Study files.
• Develop and maintain good communications and working relationships within CDM team as well as with other teams whenever requirement is there.
. Lead Performer of activity of importing & exporting of study documents saved in the system DB according to requirements of Sponsor’s, Client’s, Project Manager’s, Line Manager’s, Data Team Lead’s, Data Operation Coordinator’s & Data Entry Lead’s,
Quintiles Contract Employment History:
Date of Employment: 04/2008 - 11/2008
Name of Employer: Deputed by Ascent
Job Title: Indexing operator
Key Responsibilities:
•Team leader of indexing associates.
•Team Leader in document specialist i.e. record management activities such as counting of study data documents, sorting of study data documents, reconciliation of transmittal forms, acknowledgment of transmittal forms, scanning study data documents, printing study data documents, tracking of study data documents, Filing of study data documents, Labeling of Files, Arranging of files in file room & archiving of study data documents.
. Perform activity of importing & exporting of study documents saved in the system DB according to requirements of Sponsor’s, Client’s, Project Manager’s, Line Manager’s, Data Team Lead’s, Data Operation Coordinator’s & Data Entry Lead’s,
Date of Employment: 04/2006 - 03/2008
Name of Employer: Deputed by Handiman Service LTD
Job Title: Document Specialist
Key Responsibilities:
• Lead indexing associate.
. Perform activity of importing & exporting of study documents saved in the system DB according to requirements of Sponsor’s, Client’s, Project Manager’s, Line Manager’s, Data Team Lead’s, Data Operation Coordinator’s & Data Entry Lead’s,
•Perform document specialist activities such as printing, scanning, file room activities.
Quintiles Clinical Trial Experience:
Study Phase: Phase 1, Phase 2, Phase 3, Phase 4
Role: Data Entry
Indexing - Indexing is an archiving process of electronic images into computer DB. We enter the data belong to header information, page numbers for CRFs, DCF IDs or SDCF IDs for DCFs & SDCFs, LabIDs for Lab Report of every Subject depending upon received CRFs, DCFs & Site DCFs, Lab Report. For indexing of every study, the process is being described in DTKG specifically.
Fortis Validation: Process to verify whether Data Base is programmed correctly for indexing activity.
Data Tracking Guideline Review: Reviewing of all instructions required in scanning, indexing, tracking, filing, archiving activity of study data documents specified in Guideline.
Document Specialist or Record Management Specialist: Storing of Study Data Documents in Forms control room, counting of study data documents, sorting of study data documents, reconciliation of transmittal forms, acknowledgment of transmittal forms, scanning study data documents, printing study data documents, tracking of study data documents, Filing of study data documents, Labeling of Files, Arranging of files in file room& Archiving of Study Data Documents in specified location (Example: Sponsor) after reconciling number of pages received with number of pages archived electronically in computer DB.
Data Entry: A process to capture data recorded on CRFs for a Subject as specified in Data Entry Guidelines into computer DB.
Quality Control: A final step of procedure to inspect whether all the data are correctly processed during data entry and data validation time into Data Base.
Formal Educational History:
Educational qualification
Institution Name, Country
Area of study
Year
Percentage
Bachelors of Arts
Tripura University (India)
Tripura
2001
44%
Higher Secondary (10+2 Board Exam - Stream Science)
Tripura Board of Secondary Education (India)
Tripura
1998
52%
Madhyamik (10th Board Exam)
Tripura Board of Secondary Education (India)
Tripura
1995
61%
Extra Curriculum Activities:
Had played 2nd division club level cricket & football. Ranked 10th in state chess championship. Single champion in both chess and carom for consecutive three years in college. Became single champion in both chess & carom in sport tournament held in Quintiles in the year 2012.
Computer Knowledge: Operating Knowledge of Windows, MS Office, MS word, MS excel, Internet &
Email Operations and Power Point.
Personal Information:
Father’s Name: Late Manindra Datta Choudhury
Date of Birth: 14-Feb-1979
Nationality: Indian
Languages Known: English, Hindi, Bengali, Manipuri (mother tongue).
Declaration: I hereby declare that the information furnished above is true to my knowledge.
Date: 29/09/2016 Arunava Datta Choudhury
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