Management Project

Ajay Mohite

Email: abqruz@r.postjobfree.com

Address: **** ***** *****

City: San Jose

State: CA

Zip: 95129

Country: USA

Phone: 408-***-****

Skill Level: Management

Salary Range: $175,000

Primary Skills/Experience:

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Educational Background:

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Job History / Details:

PROFESSIONAL SUMMARY

Dedicated and extremely knowledgeable IT professional with 27 years of experience in developing and executing IT strategies, and delivering technology solutions and services in alignment with corporate objectives.

Experience working in various industries such as Information Technology, Agrochemicals, and Pharmaceuticals/Biotech.

Excellent Functional, Business Analysis, Project Management, Business Process re-engineering, leadership skills with a detailed understanding of the software development life cycle.

Extensive functional expertise in SFA, ERP (finance, manufacturing, and HR), Data warehousing, Business Intelligence, Master Data Management, Quality Management Systems (CAPA/Deviations/Change Control)

Problem solver with excellent analytical skills and ability to develop win/win solutions.

Quick learner with excellent understanding of business processes and issues.

Collaboratively managed technical and functional teams to achieve organizational goals.

A proactive self-starter, highly organized, comfortable working in a fast-paced changing environment.

Expert in cross departmental co-ordination, client relations, end user training, and change management.

Strong team building and organizational skills and ability to prioritize tasks to meet business needs.

Strong customer focus and a sense of urgency to accomplish business objectives and resolve problems.

Team player with exceptional listening, communication, and documentation skills.

Over 17 years of experience in Life Sciences industry serving as the vital link between Commercial, Clinical, Regulatory, G&A and IT applications/operations. Expanding sphere of responsibilities in IT domains supported from Application development, ERP, Business Analytics, Compliance and IT infrastructure.

KEY ACCOMPLISHMENTS

Built business partnerships with Finance, Operations, Sales and Marketing, and HR teams ensuring all effort focused on meeting business defined priorities and requirements.

Developed key operating procedures and SLAs for enterprise applications including change control, resulting in efficient use of resources and improvement to overall business satisfaction levels.

Led the implementation of NetSuite ERP (AP, Procure to Pay, and GL).

Led the implementation of Veeva SFA (Salesforce platform), Data Warehouse, Business Intelligence, Learning Management System, and Concur Expense Reporting.

Developed and implemented the full range of commercial applications for Agrochemicals Division of TATA group (India) including Inventory Control, Financial Management, Purchase Order Processing, MIS Reporting, Production Planning, Budgeting and Payroll.

Managed all facets of Oracle ERP Applications Suite (AP, AR, Purchasing, HR, Planning, etc.).

Project and Technical Lead for implementing Siebel CRM (for Clinical Trial Management)

Championed the change management to meet FDA 21 CFR Part 11 regulations for Computer Systems Validations.

Managed IT SOX controls, consistently achieving compliance.

PROFESSIONAL EXPERIENCE

AFFYMAX, INC. - Palo Alto, California Feb 2009 - Feb 2013

Associate Director, Enterprise Applications

Leading the IT applications group in implementing and validating various applications to support the commercial launch of company's first product in NA.

As member of IT Management team responsible for all the IT Applications/Operations group decisions within the company.

Responsible for all enterprise applications at Affymax such as AE Drug Safety systems (Argus, Arisg, Oracle AERs, Clintrace), Livelink EDMS, SAS, QMS, NetSuite ERP (Saas), Concur Expense Reporting, Veeva SFA, SlimStat, ComplianceWire Learning Management System.

Successfully Implemented cloud based NetSuite ERP and Concur Expense Reporting application for Financials. Worked with business to design the business processes, workflows, and customizing the application to meet company's business need.

Successfully passed ITGC SOX audit for new ERP System.

Successfully Implemented cloud based salesforce system Veeva in eight weeks.

Played a lead role as Master Data Management data warehouse architect and business analyst in the implementation of commercial systems.

Responsible for the development of high level technical and functional solution architecture, frameworks, scope and designs based on business and functional requirements such as scalability and performance.

Designed and evaluate Real Time and Batch Customer Data Integration.

Facilitate and lead workshops focused on customer data pain points and arrive at a suitable customized customer maintenance module in Veeva and assist with making business decisions around customer hierarchy, relationships, data quality, and integration.

Designed a web-based Customer Maintenance solution for Non-Veeva users to submit the request for adding new HCPs, changing addresses, facilities and also making it easy for the data governance team to handle the customer request.

Participated in the design and evaluation of data quality stewardship and governance policies and procedures for commercial systems.

Created web-based solution

* To track and resolve outstanding queries to study sites in order to facilitate data provision to the Event Review Committee, a key deliverable in the Phase 3 peginesitide program.

* Open Query Aging Report by Study, Data Pages Summary Report for all phase 3 studies

* Query Summary Reports and Last Patient Last visit Report

* Other reports to track database close activities

* Metrics Management on CFR expected, entered, queries open, closed, and aging query.

Designed and Implemented custom workflow in EDMS system for review and approval of IT validation documents, protocols, and SOP.

Migrated in-house developed quality management system MS Access database to SQL Server Database.

Responsible for review and approval of IT Validation documents for GXP systems and also participated in IT mock audit for GXP systems.

Managing internal

JAZZ PHARMACEUTICALS - Palo Alto, California Aug 2006 - Jan 2009

Senior Project Manager, Business Information Systems

Technical and Project lead in implementing Siebel Clinical for Clinical Trial Management and tracking Investigator Initiated Trials for Medical Affairs.

Technical and Project lead in implementing Quality Management System - SmartSolve from Pilgrim Software.

Currently working on implementing Datalabs, a clinical data management system and technical support for Drug Safety System - Arisg.

Coordinate the entire IT project lifecycle, including development of scope, business requirements, functional and technical specifications, development, testing and implementation.

Work with the IT team to identify and define system enhancements to various systems including Clinical Trials, Data Management, Drug Safety and other validated systems.

Perform system installation, configuration and patch management.

Perform systems validation and create all necessary validation documentation.

Help define, track and manage the project budget.

Track issues and project status while maintaining an up-to-date project plan.

Work with cross-functional teams to execute project implementation plans

Schedule and facilitate status and review meetings for team members and project sponsors.

Create and maintain project-related documents including system validation scripts.

Coordinate training for both end users and IT staff.

Support remote and local end-users on all IT related issues.

Anticipate and manage the tasks and/or risks within each phase of the projects.

Track projects, including meeting schedules and supplying status reports.

Manage post production support and adjust implementation where necessary.

Develop, document, and implement best practices to improve business processes.

Have a strong understanding of Windows 2000, XP, 2003 operating systems and databases, including ORACLE and MS SQL.

Build and maintain relationships with vendors and collaborators.

SCIOS, INC. - Fremont, California Jan 2005 - Jul 2006

Enterprise Application Administrator

Joined an operating company of Johnson & Johnson with the top-selling drug in US and several others in development to implement, troubleshoot and manage all Validated Clinical Systems including Clintrial, ComplianceWire and Quest and Oracle ERP. Maintain users, assign training, generate reports and communicate upgrades, features, releases and downtime to users.

Instrumental to higher efficiency and productivity by identifying IT resources and technical requirements for system implementation to replace a primarily paper-based system.

Collaborate with peers to roll out systems on time and resolve any connectivity issues.

AMGEN (FORMERLY TULARIK) - South San Francisco, California Jan 2003 - Nov 2004

Application Support Analyst/Clinical Database Administrator

Served as the sole IT resource for the entire Clinical Development Group. Database Administrator responsibilities included maintenance and upgrade of WHODRUG dictionary, MedDRA dictionary in Clintrial 4.3, Oracle AERS, MasterControl and dsNavigator.

Took over as Project Leader to implement the validated SAS 8.2 environment in record time of 1.5 months after the newly purchased software sat unused due to limited resources; personally authored Validation Plan, Functional Requirements, System Design Specifications, IQ, OQ and PQ.

Saved at least $20,000 in consulting fees by single-handedly performing the front-to-back upgrade from Oracle AERS 4.2.2.1 to the Web based AERS 4.5 version, leaving only the cost of data conversion.

Coordinated and led implementation of an intranet application for the clinical development department to enable sharing of documents such as patient enrollment information, study protocols and meeting minutes.

Produced dynamic SAS reports for Lab Normals and Missing CRFs to provide senior management with daily updates of information that previously took much longer to compile in Excel spreadsheets.

Performed the full range of system administration duties for Oracle Apps 11i including maintaining user accounts, troubleshooting technical issues, testing patch installations, fixing bugs and setting up ADP interface.

Proactively resolved all pending issues and several new ones during a three-week vacation of the person in charge; in addition, establishing backend access to the test server, once again saving money for the company.

GILEAD SCIENCES, INC. - Foster City, California Aug 1997 - Oct 2002

Senior IT Specialist

Brought on permanently after successful consulting project through Majesco to manage IT functions, processes and support for Global Drug Safety, Clinical Data Management and Biostatistics groups of this rapidly growing Biotech Company positioned as a leader in HIV products. Performed Unix System Administration and backup. Served as technical lead for various implementations, executed requested changes in Clintrace Adverse Events Database, developed custom reports and participated in review and assessment of Safety and Clinical Databases.

Senior IT Specialist - continued

Served as Technical Lead during implementation of Oracle Clinical, handling both front- and backend installation to reduce consulting expenses and complete project ahead of schedule.

Took the initiative to remotely upgrade and validate the Clintrace System used by newly acquired Nexstar Pharmaceuticals in Denver, Colorado to save Gilead in excess of $200,000 in consulting fees.

Brought much needed expertise in the Clinical environment to lead the IT group in maintaining the Clinical Information Systems at an exceptional level of efficiency and effectiveness.

Installed, tested, qualified and administered the Clintrace System (Adverse Event Reporting)/Database and executed upgrade from 2.6 to 2.8; authored Installation and Data Migration Protocol and evaluated system for 21 CFR Part 11 compliance.

Played a key role in team effort to implement MedDRA and E2B submission for EMEA region.

Participated in the installation and validation of Cheminformatics Suite of RS3 Products, Clintrial 4.3, Biostatistics tools and SAS.

MAJESCO SOFTWARE - Santa Clara, California Mar 1995 - Jul 1997

Senior Software Engineer

Completed three successful consulting projects on behalf of this offshore unit of previous employer Mastek, one of India's top 10 software-consulting companies. Primary duties and accomplishments included:

Gilead Sciences, Inc. - Foster City, California

Saved Gilead thousands of dollars in consulting costs by working with supervisor to create an in-house Clinical Data Management System and subsequently handling all troubleshooting, user training, fine tuning, backup, validation and report creation functions following supervisor's departure.

Responsibilities included supplying IT support to Biostatistics and Data Management groups, mapping COSTART dictionary terms, uploading data into Oracle database and creating CRF data entry screens.

Hewlett Packard/City College - San Francisco, California

Contracted to assist HP on a mainframe to HP 9000 Unix/Oracle conversion and re-engineering project for City College's Student Information System.

Performed pre-production testing and validation of the new GUI interface built with Oracle Forms and Reports as the front-end tools.

Fritz Companies - San Francisco, California

Designed, wrote and implemented specifications for new Oracle Reports for a key client as an integral member of the team charged with modifying an existing Shipping Order System.

MASTEK LTD. Feb 1994 - Feb 1995

Programmer Analyst - Bombay, India July 1994 - February 1995

Gathered user requirements to code and test a Hardware Resource Management System as a key development team member within a leading Indian consulting firm. Designed reports using Oracle v7, SQL Forms, PL SQL 2.0 and Reportwriter 2.0. Performed unit and system testing.

Senior Software Engineer - Singapore Feb 1994 - Jun 1994

Contracted to Jurong Cement Works to serve as software consultant charged with modifying an existing Sales Order Processing System. Programmed changes in ICL COBOL on ICL mainframe machine running ME-29 operating system.

Quickly came up to speed on totally unfamiliar ICL mainframe environment in the space of one week to complete project on time, enabling client to accurately track and report sales and inventory information.

RALLIS INDIA LIMITED - Bombay, India Feb 1984 - Oct 1993

Systems Analyst June 1985 - October 1993

Successfully transitioned to IT role with this $500 million (Indian) member of the country's premier TATA Group of Industries. Developed and implemented the full range of commercial applications within the Agrochemical Division including Inventory Control, Financial Management, Purchase Order Processing, MIS Reporting, Production Planning, Budgeting and Payroll.

Interacted with users and senior management to gather functional requirements, allocate computer resources and coordinate training for all users on various applications.

Analytical Chemist Feb 1984 - Jun 1985

Collected and evaluated plant samples for purity and emulsion stability in a Quality Control laboratory.

TECHNICAL KNOWLEDGE BASE

Hardware: HP 9000, HP 3000, ICL Mainframe, Personal Computers, Sun Sparc Classic, IBM Mainframe, AS/400, Dell Servers, Legato Backup System.

Databases/4GL: Oracle 11g, Oracle Forms, Oracle Reports, Image Network Database, Oracle Discovery Query Tool, Integrated Review Query Tool, and MS SQL Server.

Programming Languages: Java, C, COBOL, HTML, and PL/SQL. Knowledge of PC SAS, UNIX SAS, DBMS/Copy.

Operating Systems: HP-UX, Solaris 2.6, MPE/V, ME-29, UNIX, DOS, OS/400, Windows NT/2000/XP, Citrix Terminal Server Meta Frame 1.8.

Other Tools: Oracle OBIEE, Scitegic Pipe Line Pilot Reporting Tool, Spotfire.

EDUCATION AND SPECIALIZED TRAINING

UNIVERSITY OF SAN FRANCISCO 2008

Master of Science in Information Systems

SIES COLLEGE - Bombay, India 1985

Diploma in Computer Management

BOMBAY UNIVERSITY - Bombay, India 1983

Bachelor of Science, Chemistry

UNIVERSITY OF CALIFORNIA SANTA CRUZ EXTENSION - Santa Clara, California

UNIX System Administration

Developing Web Applications using Oracle WebDB, PL/SQL

Java Programming

SAS Programming for Clinical Trials

Clintrace 2.6 System Administration Training (Adverse Events Monitoring System) - Domain Pharma

Oracle Clinical Database Administration Training - Oracle

Oracle Clinical v3.0.3.5 Training

Business Analyst Certificate in SAS - SAS Institute, San Francisco

Training in Business Intelligence and Data Warehousing using Oracle Business Intelligence

NetSuite ERP System Administration

Livelink EDMS System Administration

Training in SAP FI/CO

Aris Global - Drug Safety System

Seibel Clinical 8.0

SmartSolve 8.0 - Quality Management System

Datalabs - Clinical Data Management System from Clinphone.

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