Senior System Consultant Resume

SUMMARY

Over 20 yeas computer system background; More than 10 years system design, implementation, validation and support for pharmaceutical industry
In-depth pharmaceutical business knowledge – Drug Safety, Clinical study and systems (Clintrace, ARISg and Oracle ARES)
Familiar with Government regulation (FDA, Health Canada, EMEA); GCP, GMP, GxP for pharmaceutical; ICH Guidelines/standard;
Certified as MCSD.NET, MCAD.NET. Able to write complex codes/scripts (C++, C#, VB, T-SQL)
Good communicator, quick learner with extensive problem-solving and leadership skills

Professional Career Overview

2008/04 – present Senior System Consultant – Confidential,
Design and implement customized solution for Drug Safety and Compliance for AstraZeneca US and Canada.

Lead the User/ business requirement gathering and URS documentation
Lead functional design and FRS documentation
Lead system architecture design and ARB document
Lead System detail design and data modeling, create screen prototypes and detail design document
Build and lead the development team. Conduct code review, test script and test QA review
Participate the critical module and script coding (T-SQL, C#, Javascript, AJAX)
Lead the enterprise environment implementation (DEV, Stage, QA, PRD) management;
Lead the SAT and UAT script creation, testing implementation
Work with QA and validation team for validation plan and implementation
Work as member of release panel to review the project progress, risks and readiness
Lead the Operation/Maintenance SOP, User training SOP and risk management documentation
Support application as SME after go-live during warranty period and Knowledge transfer to outsource team

About project:

ASP.NET web solution – ASP.NET, VS 2005, Ajax, Web Services, SSIS; Internet and intranet; Oracle and SQL database
Replacing Clintrace
Internal and external AE WebForm to collect AE data from all sources (Sales rep, Medical Info, Clinical study, licensing partner, external vendor)
AE Webform Integration with call center application
Integration with Argus Safety database and Business object for reporting
E2B data format for exchange data with global database.
Global AE data importing automation (including CIOMS)
AE Portal – dashboard to remind the AE process, reporting and compliance
AE process and compliance Workflow
Content management and AE document repository (EDC) and fax automation
Very successful project. Client is happy with the system and it helps to pass the FDA audit in 2009 for AZ US

2003/01 – 2008/03 Senior business analyst and solution designer / Confidential,Canada
Work closely with business partner to gather the requirement and do GAP analysis; Work closely with system architect to lead the solution design for customized system; Lead the system and data modeling; Propose and document the solution; Support business partner to sell the design to business user; Review the Architecture for the solution by third party or outsource company; Work as member of release panel to review the project readiness, risks and strategy; Review the technical documentation (detail design, technical specification, validation and release control etc)
Lead/participate the test script (SAT, UAT) creation; Review the scrip; lead the testing; Participate the system validation planning, implementation and documentation.
From time to time, participate in the key module coding/scripting. Support business critical systems (Business as usual)

Main Projects:

Drug Safety System (Customized solution. Client/Server)
Clinical Study Management and AE/SAE reporting (Customized solution. Client/Server)
Regulatory Submission management (Customized solution. Client/Server)
Others

Data warehouse – COGNOS and EDW; Cheque Requisition and SAP Reporting; SIEBEL CRM; Technology Innovation (MOSS – SharePoint evaluation)

1999/06 – 2002/12 Program Analyst (consultant) / Confidential, Canada
Software design and development for customized solution – mainly client/server; data migration; system support;

Education

Bachelor\'s Degree, Computer science and computational mathematics

Technical Skills

Systems and Platforms:

Windows /NT/2000/XP/Vista/2003/2008, IIS, Exchange Server, BizTalk, Sharepoint Server
MS.NET framework (1.0,1.1,2.0, 3.5)

Database:

SQL server (8, 200, 2005, 2008), Oracle (9i, 10g) 8+ years

Including BCP, DTS, SSIS, SSRS, SQL*Loader, SQLPLUS, SQL Developer

Data modeling and database construction

(Table, Relationship, View, Index, Constraint, Database object scripting)

Complex SQL script and SQL tuning

Programming Tools:

Visual Studio 2003, 2005, 2008 - C#, VB.NET, C++, VB/VB Script, javascript, HTML
Reporting tools – Business Objects, crystal Report, SQL Reporting

Others

MS-Office, VISIO, Project, UML tool, Active PDF Tool

We provide IT Staff Augmentation Services!

We'd love your feedback!

Resume Categories

Client Services

Job Seekers

Visa Sponsorship