Soumyabrataa Chakraborty

*

Clinical Data Management, Risk and Compliance (Health Sciences)

+1-757-***-****

ac4kpe@r.postjobfree.com

Professional Summary

6.5 years of Clinical Data Management and Risk/Compliance experience in Life-Sciences and IT Organizations. Worked in diversified roles of a Clinical Data Analyst, Risk and Compliance Specialist and Study Setup Programmer.

Specialties

• Drug Development Lifecycle

knowledge

• Conduct of Clinical Trials

• Clinical Study Set up

• Database programming,

• Data cleaning, Data migration

• Clinical Data Standards - CDISC-

SDTM

• SAS, SQL

• SDLC Audit

• Regulations and Guidelines - ICH E6

(GCP), GDP, 21CFR11, ICH Q9, ICH

Q10

• CAPA

• Process Deviation Management

• Creation of SOPs and WI

• QMS Review

• Process Risk Management

Career History

Organization Role Duration

Oracle Corporation Risk and Compliance Specialist

(HSGBU)

Jun ’13 – May ‘15

Cognizant Technology Solutions Clinical Data Analyst Nov’09-May’11/May’12-May’13 GlaxoSmithKline Pharmaceuticals

Ltd

Study Setup Programmer Nov ’07 – Oct ’09

Academic Background

• Post Graduate Diploma in Bio-Informatics from IBAB, Bangalore

• Bachelor of Technology (BTech) in Bio-Technology (2002-2006) Trainings and Certification

• ISO 31000:2009 Risk Management Principles and Guidelines certified

• Programming Essentials from SAS institute, Bangalore

• Manipulating Data with a Data Step from SAS institute, Bangalore

• SAS Macro Programming from SAS institute, Bangalore

• ADaM training at CDISC, Singapore

• Medical and Clinical Operations Workshop, GlaxoSmithKline, Hong Kong Awards and Recognitions

• “Performance Excellence” award at GSK in September 2008 for creation of process documents.

• Millipore Scholarship for Best Women student at IBAB, 2008 Soumyabrataa Chakraborty

2

Professional Expérience Détails

Oracle Health Sciences GBU Risk and Compliance Specialist Jun ’13 – May ‘15 Project: 1

Client: Oracle Health Sciences

Primary Role: Risk Management and Regulatory Compliance Specialist Project Description: The purpose of the role is to ensure that the products developed within Oracle Health Sciences GBU are aligned to the regulatory guidelines, health sciences best practices and Oracle processes. This was achieved by continuous monitoring and periodic audits. Roles & Responsibilities:

• Providing process related inputs to various teams involved in product development in perspective of SDLC process (waterfall, agile), Good Documentation Practices, Health Sciences guidelines, HIPAA, PHI, 21CFR11, data privacy, Oracle SOPs/guidelines/Work Instructions, necessary documents and milestones.

• Responsible for Risk and Compliance related query resolution of projects.

• Conduct SDLC (waterfall/agile) audits of quality management system for product development. Duties included creation of Audit Agenda, meeting up with the teams on regular basis to explain the audit at first and find out in details about the audit, audit execution, creation of audit report and closing out of audit with audit certificate.

• Checking accuracy of training records and CVs of project team

• Checking and documenting any process deviation, if any, during execution of a project.

• Act as the Audit group reviewer and signatory for various documentation and meetings during the course of SDLC.

• CAPA management: Responsible for creation, triage, tracking, resolution, documentation and closure of Corrective action requests (CAR) for allocated projects.

• Involved in creation, updating and modification of process documents such as SOPs and Work Instructions.

Cognizant Technology Solutions Clinical Data Analyst Nov’09-May’11/May’12-May’13 Project: 2 and 3

Client 1: One of the largest Swiss Pharmaceutical major with a revenue of ~ $50 billion USD Client 1: One of the largest Danish Pharmaceutical major Primary Role: Clinical Data Analyst

Project Description: The projects required conversion of Client provided raw data (Clinical trial) to target SDTM compliant datasets and build Clinical Data Warehouse. Roles & Responsibilities:

• Extensive use of Study Data Tabulation Model(SDTM) as defined under Clinical Data Interchange Standards Consortium(CDISC)

• End-to-End Legacy Data Conversions into SDTM domains for eCTD Submissions

• Analyze Clinical trial documentation (study protocol, raw datasets, and analysis datasets) and highlight any source data discrepancy. Early understanding of data challenges.

• Mapping of data fields from source to target Data warehouse using CDISC SDTM/SDTM based Soumyabrataa Chakraborty

3

client specific standards and domains after analyzing the source data and referring to the CRF and protocol.

• Creation of Business logic (SQL,SAS) and derivations for mapping

• Metadata Management of clinical data. Setting up Meta data of the trial after referring study CRF, protocol, Clinical Study Report.

• Transfer of data from source to data warehouse (SAS).

• Validation(structure and content) of target datasets against the published SDTM domains using SAS and SQL

• Use of Open CDISC and WebSDM validators

• Define.xml creation

• Preparation of Migration Report

• Creation of SDTM CRF Annotations and bookmarking adhering with characteristic properties & specifications

• Handling all project activities & deliverables, involving end to end legacy conversions into SDTM

• Productivity enhancement by continuous knowledge sharing and playing a role of a trainer, guide and mentor to the team

GlaxoSmithKline Study Setup Programmer Nov ’07 – Oct ’09 Project: 4

Client: GlaxoSmithKline Biologicals

Primary Role: Study Setup Programmer

Project Description: Study set-up team in Rotarix TM project was responsible for CRF review, creation of study database/ data entry screens, writing of edit checks and data cleaning programs, assist in data entry, data cleaning and creation of datasets for statistical analysis. Roles & Responsibilities:

• Sole responsible for the project

• CRF review and annotation

• Creation of the database [Oracle]for each study [clinical trial] within the assigned project

• Creation of the data entry application [for paper encoding and e-Capture] using organization specific tool.

• Writing of SAS macros and SQL statements for edit checks, automatic and manual cleaning

• Monitoring, maintenance and updates to each study database and programs as an when necessary

• Assisting the data encoding process and the data cleaning process in issues related to database or the computerized data validation procedures

• Validating and testing similar processes of peers.

• Creation of SAS data sets for statistical analysis.

• Active participation in preparation of Data management Plan document.

• Active participation in global task forces for SOP management.

• Responsible to make frequent presentations to update team for various SOP and processes changes

/modifications after attending any conference/training.

• Organizing or chairing meetings for concluding on study related activities as a part of process or for resolving any issues.

• Exposure to project audits and passing it with success.

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