Kumar M.doc

8/14/2019 Kumar M.doc

1/10

Kumar M, PMP, CITPM (Associate), SCEA

Professional Summary Over eight years of experience as a Project Manager in HealthCare and Trade

& Logistic, Supply Chain do ains!

Certified Project Manager wit Project Management ProfessionalCertifications (PMP) from PMI (Pennsyl!ania, "S), Certified IT #rojectManager from Singa#ore Com#uter Society (SCS)

Highly disciplined and ulti"s#illed, $ho can align strategic o%jectives of theorgani ation $ith project o%jectives

Strong #no$ledge of CTMS and its relevance to clinical research organi ations' C$%s (, $e%"%ased electronic data capture ' E&C ( in )ML for at for Clinic

Trial Manage ent 'CTMS(,clinical data anage ent ' C&M ( , *lectronic CaseSu% issions Module ' ECSM (, C&ISC standards li#e L+ - for exchanging la%data, %&M - Operational .ata Model, S&TM - Su% ission .ata Model, +.aM- +nalysis .ataset Model and reporting and analysis of data!

/a iliar $ith '&A C'$ Part $egulations related to Phar aceuticalindustry, anage ent of drugs and disease related data, ris# %ased

approaches to C/0 Part 11 to allo$ the regulated industry to analy e,strea line and control The electronic record, +udit trails, *lectronic copies forinspection, 0etention and aintenance of records, Hy%rid and proceduralsolutions, +pplication of electronic signatures

/a iliar $ith the concepts of current 2oods Manufacturing Process ' c*MP (,good clinical processes ' *CP (, good la%oratory practise ' *+P (!

2ood #no$ledge of the solution overie$s and gaps in products li#e 3extrials,Oracle Sie%el eClinical, Phase/or$ard

Strong #no$ledge of various ' Configura%le off the shelf syste s ' C%TS (solutions, integration technologies, )ML '.T., Sche a( and integration $ithlegacy syste s!

Proven delivery trac# record of critical deadline and %udget driven co plex 4Tprojects in Latin + erica, 3orth + erica and +sia"Pacific

.elivered custo i ed presentations to ultiple sta#eholders includingManage ent Co ittees, Custo s .irector 2enerals, 2overn ent Ministersand .epart ents, *valuation Co ittees, *nd Custo ers, Project Tea s and*nd 5sers!

Possess several soft s#ills li#e negotiation, conflict resolution, controlling andanaging scope, %alancing scope, resource, ti e and 6uality issues, defect

analysis and resolution strongly aligned $ith eeting project o%jectives anddelivera%les!

Proven s#ills in anaging internal and external sta#eholders cross functionaltea s and third party vendors!

.elivered large scale solutions $ith $e%"technology fra e$or#s li#e Struts,Hi%ernate, Spring +ction 1, +7+), Tiles , 78** and Client Server technologies on

ultiple environ ents $ith tightly coupled integration $ith S+P! Strong #no$ledge of 4 M 9e%Sphere M: 9or#flo$, MicroSoft i tal# serversalong $ith concepts li#e P*L, )P.L , usiness Process 4ntegrator, Co plex

usiness 0ule anage ent! +ctive Learner, Critical;+nalytical Thin#er and Co plex Pro%le Solver

coupled $ith 7udg ent and .ecision a#ing capa%ilities! Possess Oral and $ritten Co prehensions $ith 4nductive and .eductive

reasoning %lended $ith the


2/10

9ell versed $ith concepts, ethodologies of SEI CMMI +e!el -, .S//00,$"P and "M+ and has the a%ility to learn and adapt to ne$ ethodologies%ased on project re6uire ents!

Played #ey role in achieving certification in CMMI certification inCri sonlogic %y $or#ing $ith S*4 CMM4 Lead assessors and 6uality auditors!

*xperienced in full Syste .evelop ent Life Cycle ' S&+C ( and :ualityManage ent Syste s (1MS) covering all aspects of projects fro 4nceptionto Closure!

Strong


3/10

Manager ' usiness Syste s(, Cri sonLogic Pte Ltd, Singapore " +ugust 8>>? -Present

4T Manager,Office+8@ 'Singapore( Pte Ltd, Singapore May8>>> - 7uly 8>>?

Project E7#erience

Project Title < Clinic Trial Management System - CTMS Roche0ole A Project Manager*nviron ent A Sun Solaris, 9e%logic Server B!1, Oracle 1>g .ata%ase, 78**,

7pro%e, Load 0unner, ug illa, i atis, *clipse, *nterprise+rchitect, ug illa

Project .escription A

CTMS Clinical Trial Manage ent Syste is a syste that facilitates accuratelyrecording data fro o%tained during clinical trials fro various sites geographicallydistri%uted across the 5S and internationally! This syste ensures co pliance $ith'&A standards reduces ti e to ar#et %ecause of s orter test cycles andrecords #rotocol de!iations during the test process! Test data is entered into

Sie%el eClinical, COSMOS $hich interfaces $ith a docu ent anage ent syste'.ocu entu ( using *xternal usiness Co ponents! +n interface is also aintainedinto the S+P syste for pay ents and %illing data! This is done using :M+ essagesover M: series 6ueing su%syste !

enefits of the syste includes Co pleted trials on ti e, Co pleted trials accordingto %udget, Co pleted trials $ith high 6uality, 0educed site initiation ti e, ,0educedti e to process pay ents and reduce pay ents for issed visits, 0educed a ountof C$A monitoring and ti e and expense for travel needs, Im#ro!edrelations i#s wit sites , Im#ro!ed #rotocol com#liance , ,4 proved decision

a#ing capa%ility

/eatures of the syste include Budget Planning ' provides ti ely study and study site infor ation for

%udget planning purposes( Supplies Management (Clinical & Non-clinical) 'provides enroll ent

projections and progress to support onthly inventory forecasting, trac#ing ofproducts to patients and centers, and history of product ship ents andreturns (

Grants / Payments - Supports integrated pay ent infor ation fro anexternal pay ents syste detailing pay ents ade and pay ents to %e

ade to a study site! Billing - Supports integration $ith S+P syste for %illing infor ation detailing

any invoices generated for study sites! Financial Trac ing - The syste ust trac# study %udgets on a per study

and per study site %asis, and provide access to real"ti e data on %udgetstatus and contracted rei %urse ents!

Trip !eporting " Trac#s study site onitoring visits, open issues, issueresolutions, and provide a history of onitoring visits!

Contact Management (Sponsor & "n#estigator/Site) - +llo$s entry ofinvestigator infor ation, including training history, previous studyassign ents, and center affiliations!

M = S Sanjeev


4/10

Mentored executive tea in syste s and e6uip ent i ple entationre6uire ents governed %y national and international regulatory re6uire entsincluding, C'$ Part , Part Electronic $ecords and ElectronicSignatures) , -= (*P+), (*MP), and C'$ #redicate rules, for t eP armaceutical industry8

*nsured that the solution eets /.+ re6uire ent 81 C/0 Part 11, Su%part"

*lectronic 0ecords, .ocu ented Policies, SOPs, 2uidelines, and 9or# 4nstructions ai ed at

opti i ing processes Co"ordinated audits %y regulatory authorities of syste , 0ecord retention life"

cycle, +rchival ' Short ter and Long ti e(, Security audits, 6uality anage entsyste s, *lectronic signatures, Signature;0ecord lin#ing, non"co pliance

onitoring!!Major0esponsi%ilities

A 2athered functional and non"functional re6uire entsfro project sta#eholders

Prepared SOP and policy docu ent using 5ML and=isio and presented to executive co ittee andachieved sta#eholder %uy"in!

.esigned the high"level architecture %ased on thefunctional and non"functional re6uire ents! Configured and integrated 'Configura%le Off the Shelf

( solutions COTS 4 ple ented co %ination of Spring, Struts and 4%atis

fra e$or#s! .esigned 4ntegration architecture %et$een the

application and the legacy syste s using ultipleessaging standards and protocols li#e /TP, HTTP

and SMTP 4 ple ented %usiness process integrator to

i ple ent auto ated $or#flo$s! 4 ple ented rules anage ent syste to decouple

%usiness rules fro core application thus ensuringthat the syste is ready for changes!

5sed +pache /OP, )ML and )SLT in designingregulatory reports!

Prepared high level test plan and specifications toverify the re6uire ents!

/ollo$ed usa%ility guidelines $hile leading the teain designing the user interfaces!

Led the tea in preparing unit tests and used toolsli#e load runner to perfor load tests!

+naly ed test results and ensured the %ugs aretrac#ed and fixed on ti e $ith out affecting the

project progress! Perfor ed application profiling using profiling tools

li#e jpro%e and jprofiler to ensure that there are noe ory lea#s and loitering o%jects in the solution!

riefed and guided the :+ tea to understand there6uire ents

Perfor ed functional and configuration audit toensure the final solution eets the %usinesso%jectives!

M = S Sanjeev


5/10

Coordinated the 5ser +cceptance tests $ith endusers!

Perfor ed post"i ple entation revie$ and led thetea in perfor ance tuning of applications

Prepared .eploy ent diagra s and i ple entationguidelines!

Prepared the change anage ent plan and %usinesscontinuity plan to ensure that the sta#eholders are$ell educated a%out the project i ple entation!

.istri%uted progress reports on ti e to the executiveco ittee and project sta#eholders regularly!

2uided the technical $riters in preparing thetechnical and user anuals!

Project Title < Trade6et System for I!oryCoast (Currently in progress)0ole A Chief Technical +rchitect

*nviron ent A Sun Solaris, 9e%logic Server B!1, Oracle 1>g .ata%ase, 78**, 7pro%e, Load 0unner, ug illa, i atis, *clipse, *nterprise+rchitect, ug illa

Project .escription A Tradenet is a trade facilitation syste designed %ased on 9orld Custo sOrgani ation '9CO( standards to facilitate s ooth flo$ of trade! The solution ai s atensuring paperless trade $hich ulti ately increases the speed at $hich per its areprocessed! The solution has integration interfaces $ith Custo s solution andproduces the vital trade statistics that #ey to easure the trade volu es of thenation!

The solutions #ey technical co ponents include Translation *ngine, usiness Process4ntegrator *ngine and 0ules *ngine along $ith an eCo erce Portal and an Offlineclient!

Major0esponsi%ilities

A 2athered functional and non"functional re6uire entsfro project sta#eholders

Prepared usiness Model .iagra s using 5ML and=isio and presented to executive co ittee andachieved sta#eholder %uy"in!

.esigned the high"level architecture %ased on thefunctional and non"functional re6uire ents!

4 ple ented co %ination of Spring, Struts and 4%atisfra e$or#s!

.esigned 4ntegration architecture %et$een theapplication and the legacy syste s using ultiple

essaging standards and protocols li#e /TP, HTTPand SMTP

4 ple ented design patterns extensively 4 ple entation co plex %usiness rules for taxation,

tariffs and duties, enforce ent and settle ent andalso developed integration $ith an#s using S94/Tinterfaces!

4 ple ented %usiness process integrator toi ple ent $or#flo$s!

M = S Sanjeev


6/10

4 ple ented rules anage ent syste to decouple%usiness rules fro core application thus ensuringthat the syste is ready for changes!

Participated and coordinated $ith the design tea toprepare the detail design including Class .iagra s,Se6uence .iagra s etc

3or ali ed the data%ase design +naly ed and revie$ed the technical architecture and

incorporated the non"functional re6uire ents! 5sed +pache /OP, )ML and )SLT in designing

reports! Prepared high level test plan and specifications to

verify the re6uire ents! /ollo$ed usa%ility guidelines $hile leading the tea

in designing the user interfaces! Led the tea in preparing unit tests and used tools

li#e loadrunner to perfor load tests! +naly ed test results and ensured the %ugs are

trac#ed and fixed on ti e $ith out affecting the

project progress! Perfor ed application profiling using profiling tools

li#e jpro%e and jprofiler to ensure that there are noe ory lea#s and loitering o%jects in the solution!

riefed and guided the :+ tea to understand there6uire ents

Perfor ed functional and configuration audit toensure the final solution eets the %usinesso%jectives!

Coordinated the 5ser +cceptance tests $ith endusers!

Perfor ed post"i ple entation revie$ and led thetea in perfor ance tuning of applications


riefed .atacenter and call center operations teato effectively onitor and respond to user en6uiries!

Prepared the change anage ent plan and %usinesscontinuity plan to ensure that the sta#eholders are$ell educated a%out the project i ple entation!

.istri%uted progress reports on ti e to the executiveco ittee and project sta#eholders regularly!

0esolved technical conflicts %y %rainstor ing thepros and cons of different technical solutions!

2uided the technical $riters in preparing the

technical and user anuals!

Project Title < Port Community System0ole A Chief Technical +rchitect!*nviron ent A Sun Solaris, 9e%logic Server B!1, Oracle 1>g .ata%ase, 78**,

Hi%ernate, 7pro%e, Load 0unner, ug illa, i atis, *clipse,*nterprise +rchitect, ug illa, Spring, 9e%Services

M = S Sanjeev


7/10

Project .escription A9ithout an orchestrating centerpiece of a Port Co unity Syste , interactions%et$een port co unity sta#eholders are largely peer to peer! PCS is a unifiedplatfor for port co unity sta#eholders including %ut not li ited to Custo s+d inistration ,4 igration, Ministries ; 0egulatory odies, Portauthority,Stevedores,4 porter;*xporter ' +lso called Shipper ; 0eceiving+gent(,Shipping Line, /or$arding agent, Custo s +gent, Mariti e Carrier, 4nland

Carriers, an#s and /inancial 4nstitutions that si plifies access to infor ation,strea lines processes $hile setting high security standards! This unified platforintegrates infor ation and provide single electronic $indo$ of access so that all theport co unity sta#eholders can easily vie$ enterprise infor ation, colla%orate andconduct %usiness ore effectively!Major0esponsi%ilities

A .ocu ented and revie$ed functional and non"functional re6uire ents fro sta#eholders li#e2overn ent 0egulatory %odies, Shipping Councils,

Trade 5nions, /inancial institutions li#e an#s and4nsurance agents!

.re$ usiness Model .iagra s using 5ML and =isioand presented to the various sta#eholders to presenta unified vie$ of the entire solution!

.esigned the high"level architecture %ased on thefunctional and non"functional re6uire ents using

78** design patterns, $e% services and )MLintegration interfaces!

4 ple ented the Hi%ernate fra e$or# along $ith 78ee design patterns!

.esigned Service Oriented +rchitecture to eet theco plex re6uire ents ore

5sed a co ponent architecture to ensure re"usa%ilityand availa%ility, co ponents include %ut not li itedto +uthentication, +uthori ation, Signing and*ncryption using P


8/10


Prepared and .istri%uted progress reports on ti e tothe executive co ittee and project sta#eholdersregularly!

2uided the technical $riters in preparing thetechnical trou%leshooting guidelines

Project Title < Ad!anced Passenger Information System and $is2Management System8

Client A Suvarna%hu i 4nternational +irport '3 4+(, Thailand!0ole A g .ata%ase,

78**, 7pro%e, Load 0unner, ug illa, i atis, *clipse,*nterprise +rchitect, ug illa!

Project .escription A 4n response to the terrorist attac#s of 11 Septe %er, 8>>1, 5S legislation $aspassed a#ing it andatory for all co ercial airlines on international flight to sendtheir passenger and cre$ anifest data to 5S Custo s Service +dvance Passenger4nfor ation Syste '+P4S( for advance processing %efore their arrival in the 5nitedStates! +P4S is the project in trans ission of passenger infor ation in advance %eforethe aircraft arrival at the airport fro the co puteri ed syste s of the airlineco panies to the +P4S syste of the Custo s office at Suvarna%hu i 4nternational+irport 'S 4+(! The infor ation thus received shall %e processed through profiles of$atch; %lac# list and various deter ined ris# criteria under ris# anage ent, andprepares suspected passenger list for each flight! The suspected passenger shall %eidentified and i ediately sent to the +P4S onitor in the +P4S control ande6uip ent roo and to the roversG $hen such passenger are passing through the4 igration! The solution supports i1Bn and supports *nglish and Thai languages!Major0esponsi%ilities

A Held discussions $ith +irport Sta#eholders li#eCusto s .irector 2enerals, 4nspectors, 3arcotics%ureau, +irport 4nfor ation Syste s '+4MS(,4 igration officer to gather functionalre6uire ents!

.esigned usiness Model .iagra s and +ctivitydiagra s!

.esigned the high"level architecture %ased on thefunctional and non"functional re6uire ents using

78** design patterns and loosely coupled )MLintegration interfaces!

.esigned scheduling jo%s to update retrieve andupdate +4MS and $atch lists and %lac# lists of airportsyste s at regular intervals!

.esigned and 3or ali ed the data%ase design 4 ple ented struts fra e$or#! 4 ple ented i atis fra e$or# to ensure a loosely

coupled data%ase access!

Project Title < Ad!anced &ata Collection System8Client A Pana a Canal +uthority '+CP(, Pana a!0ole A Senior Technical Consultant*nviron ent A Sun Solaris, 9e%logic B!1, 78**, Oracle 1>g .ata%ase, L.+P,

M = S Sanjeev


9/10

Message :ueue, P


10/10

Microsoft Certified Professional in =isual asic

Professional Mem3ers i# Project Manage ent 4nstitute, Pennsylvania, 5S+ Singapore Co puter Society, Singapore

Professional Training +rchitecting *nterprise 78** +pplications Soft$are :uality +ssurance and :uality Manage ent Syste s .efect Prevention, :uality Project Manage ent Planning and Managing Projects +ssertive S#ills for Managers Technical 0eport 9riting

M = S Sanjeev of 1>

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Kumar M.doc