Clinical Research, Clinical Data Management and CTMS

PAUL RAJAN.J ****.*****.*@*****.*** Mobile: +919*********

Executive Summary

Have 6 Years of experience in Clinical Research and Clinical Data Management with 8 years of total experience in Information technology.

Technical Skill Set

PACKAGE PROGRAMMING LANGUAGE OPERATING SYSTEM CDMS DWH& DATABASE NETWORK

XHTML,DHTML, XML, Java Script, VB Script, Photoshop, Frame maker, MS Office 2007,Microsoft Project, Microsoft Visio, ASP with IIS Server

SAS 9.1.3, SQL Server 2007, My SQL, PL/SQL, Visual Basic, Java , C, C++ and Perl Windows 7, Windows 2000, Server 2003 R2, Vista, XP, Unix, Linux RH, Fedora ,Novell Netware, Solaris

Oracle Clinical 4.5.1, Datafax , SAS Pheedit 3.0, Open Clinica,

Rave, Clintrail 4, Inform EDC, MedDra 10.1, Kinetica 4.4.1, WinNonlin 5.2, AERS 4.5.2

. Business Objects, Oracle 10g (DBA), Oracle 9i (DBA),Oracle AS 9, MS-Access, MS-SQL, MS SQL Server,Postgresql Active Directory,

DHCP,

DNS,

VPN(P2P),

Employer History

Micro Therapeutic Research Labs Pvt Ltd, Chennai February 2008 - Till Date

Project Clinical Data Management– Project Initiation, Study set up, Ongoing operations, Review and study close out.

Project Description • Develop a database and web based eCRF for Phase I & II studies according to the sponsor requirement and Study protocol.

• CRF Design and Review

• Develop DMP, Edit check specifications and Validation Plan, Database Design and Structure.

• Data Mapping as per CDISC standard

• Statistical Programming for (TFL)Report Generation using SAS

• Deliver the analysis report as per Safety / Efficacy endpoints for Clinical Trials & BABE studies.

• Pharmacokinetic data analysis (Using WinNonlin)

• eCTD Preparation for USFDA submission studies (CDISC SDTM).

• Assist in CSR preparation and medical review.

• Budget Preparation for CDM projects

• Budget, NDA and CTA preparation of Clinical Trial Projects

• Client interaction and project initiation

• Internal Audit and Metrics calculation

• Computer system validation (GAMP)

• Hardware and Software validation (21 Part 11 compliance)

• SOP and WP preparation and review.

Role &

Responsibilities Manager CDM – Managing and assign task to CDM Team ,

Study plan and execution, Project coordianation, Client interaction and Project management.

Previous Experience

Oxford Pharmaceutical Sciences, UK September 2007 – December 2007 (Contract)

Project Clinical Data Management– Project Initiation, Study start up and complete

Project Description • Attend 1 week sponsor training to set up a study database

• Develop a database according to the sponsor requirement

• Provides planning, construction, testing and maintenance of clinical database in Oracle Clinical for assigned studies, Set up user / study privileges and design e-CRFs.

• Define data standards and develop the clinical study database with specific reference to Oracle Clinical

• Deliver SAS datasets to Statistical Programming for interim analysis

• Interact with sponsor on a daily basis to deliver timely, high quality data

Duration 09/2007– 12/2007

Role &

Responsibilities Clinical Data Analyst – Working in a sponsor database to create study and generate reports according to the study protocol.

Technology SAS 9.1.3,Oracle Clinical 4.5.1,Windows XP, Office 2007

IRL Research India Pvt Ltd, Bangalore June 2006 - September 2007

Project Clinical Data Management– Project Initiation, Study start up and complete

Project Description • Take on Lead role for assigned projects to ensure all data management activities comply with IRL Research quality procedures and SOPs

• Provide timely and ongoing quality management of clinical trial data according to ICH GCP guidelines

• Provides planning, construction, testing and maintenance of clinical database in Oracle Clinical for assigned studies, Set up user / study privileges and design e-CRFs.

• Define data standards and develop the clinical study database with specific reference to Oracle Clinical

• Review and contribute to the development of the clinical data model and/or database design with specific reference to OC 4.5.1 / RDC 4.5.1

• Deliver SAS datasets to Statistical Programming

• Review and contribute to the development of Tables, Figures and Listings

• Setup Lab units and Lab ranges for Lab reconciliation

• Data extraction and loading

• Writing SOPs as per 21CFR part 11, cGCP, GCDMP

• Review and contribute to the Case Report Form (CRF) (paper or electronic) or Data Collection Tool design

• Act as an advisor and mentor to new members of the Data Management group overseeing activities with specific reference to CDM process, SAS and Oracle Clinical.

• Interact with internal and external customers to deliver timely, high quality data

• Assist in the development and validation of new Data Management processes

• Evaluate existing processes and implement best practices

• Maintain Metrics for Resource allocation and Project Timelines

Duration 09/2006– 09/2007

Project Clinical Data Management– Installing Software, Hardware and Networking for CDM services

Project Description • Heading with the assessment, strategy and implementation of new technologies, primarily Oracle Clinical 4.5.1 and SAS 9.1.3

• Install OC 4.5.1 and SAS as per FDA CFR (IQ,OQ & PQ) guidelines

• Maintain PSUB and Report servers and executing batch job and schedule job services.

• Install SAS software for mapping and reporting the final data

• Worked in SAS Base, SAS SQL,SAS Graph ,SAS Macro,SAS Stat

• Data transfer from OC to SAS (Views / SAS Access)

• Oracle DBA task for managing-Roles, Profiles, user creation, workflow

• Validate CDM systems as per CSV for controlled environmental audit

• Monitor the Data security, Network security and VPN network

• Monitor the Data backup and recovery.

• Interacting with CDM Software vendors and IT vendors to setup state-of-the-art Technology.

• Financial management for software and hardware purchase and ordering

Duration 06/2006 – 09/2007

Role &

Responsibilities Manager CDM / IT – Implement CDM service related software and manage the CDM team for project execution.

Technology SAS 9.1.3,Oracle 10g, Oracle Clinical 4.5.1 with RDC 4.5.1, Windows server 2003 R2, Windows XP/Vista, Adobe Writer 8.0, MS Office 2007, McAfee 8.5i with Protection pilot 1.1.2, HP DL380 Compaq server with Raid 5 Technology, HP ultrium Backup drive.

Icon Clinical Research India Pvt Ltd Dec 2004 – June 2006

Project Oracle Clinical Application based Projects

Project Description • Worked in more than 75 different studies in different therapeutic areas on different phase.

• Work with more than 15 international sponsor projects.

• Design CRF as per CDISC and Non-CDISC format

• Review study specification guidelines and protocol

• Set up Study Domain, Programs, Events, Phase, Intervals and Region for Early Phase I to IV studies as per study guidelines.

• Set up user access and study access

• Set up the easy study design

• Set up the global library

• Using TMS link with Coding tools

• Set up Questions, Question Groups, DCM, DCI,DCI Book

• Set up discrete value group

• Generating Layout as per the CRF

• Set up qualifying value for each page

• QC by test data entry pass 1 and 2.

• Review and Activate Validation and Derivation procedures

• Writing Pl/SQL program for derivation procedures

• Set up user define variables

• Generate procedures and execute test data to validate the check.

• Resolving Discrepancies, creating LAB with Ranges, Units and assign Lab criteria.

• Extracting views from oracle to SAS

• Write transfer program to convert oracle views into SAS datasets.

• Coding for safety data

Project DATAFAX

Project Description • Set up Study Domain, Events, Phase, Region and Intervals

• Set up the global library

• Set up discrete value group

• Set up field length as per the CRF

Edit check programming

Project SAS

Project Description • Create summary tables, listings and graphs as per statistical analysis plan and final annotated CRF

Duration 12/2004 – 06/2006

Role &

Responsibilities Database Administrator – Annotating CRF, Design, development, testing, review (test data), integration testing, redesign, transfer program and leading the study team.

Technology SAS 9 ,OC 4.5,Data fax, Opticon, Oracle 8i, Windows XP, Windows 98 ,Unix Server ,Adobe Writer, MS Office 2003

Education

• Master of Computer Applications, Bharathidasan University, Trichy, India, Year 2000 – 2003

• Bachelor of Computer Science, Bharathidasan University, Trichy, India, Year 1997 - 2000

Training in CDM Application software and supporting tools.

• Has undergone a 3 months training in Oracle Applications (ICON)

• Actively involved in Installation, Development and customization of Oracle Application (OC4.5) , PL/SQL APIs,

Opticon.

• Coding tools-MedDRA which supports Oracle to enable TMS facility

• Data fax training to design and set up the study

• Training in Base SAS to create Tables, Listing and Figures

• Excellent knowledge in Medidata RAVE 5.2 EDC software

• Exposure to Phase forward’s Clintrail, Inform ITM and Empirica Trace software

• Training attended for using Image Viewing Software and document management softwares

Training attended in Clinical Research and other

• Attend Training in Process involved in Clinical research and the subsystems

• Good Knowledge in Quality assurance and auditing (CDM& CR)

• 21CFR Part11, CDISC SDTM, eCTD, GCP,GRP, Regulatory and ICH guidelines as applicable to Data management, GCDMP (April 2009), Schedule Y and Data Privacy.

• Faced USFDA study audit and involved in ANVISA facility audit.

• Participating in a ISO 9001:2004 ,ISO 27001:2005 audit

• Training in Pharmacovigilance from WHO, Uppsala, Sweden

• Conference on Clinical Research Development in India

• Attend the training in a 65 bed SMO hospital to gain knowledge about Clinical Trails (UK)

• Good knowledge and experience in BA/BE study conduct and study report preparation

• Good exposure to conducting Oncology BA / BE studies in patients.

• Sound Knowledge in Preclinical and Bioanalytical process

• Experience in Conducting, Executing and Reporting Clinical Trials

• Communication Skills and Team Building skills by English Training Centre

• Website Design and Hosting

Training attended in Software and Hardware

• Training attended in Oracle Database administration at CSC computers

• Certificate course in ASP and SQL server from NIIT

• Diploma Course in Information Management System

• Certified Hardware and Network Engineers from Compucare.

Contact Details: Personal Profile:

Paul Rajan.J Father Name : Joseph Raj S

1/44, Moovendhar Nagar, Mathakottai Road, Thanjavur Date of Birth : 22 October 1978

Mobile : +91-989******* (Current Contact No) Marital Status: Married

Mail: ****.*****.*@*****.*** Passport No : E4997547 Validity – 2013

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