OBJECTIVE:

To secure a position in the organization that offers challenge and opportunity for my career development and at the same time serve the organization to the best of my capabilities. I would like to gain new skills while utilizing my current area of expertise with in a positive team environment.

SUMMARY:

Result oriented IT project management professional with over 10 years of providing innovative technological solutions in the life sciences and healthcare domain. Extensive qualifications in all aspects of project management, system administration, development, maintenance, operations and production support. Articulate communicator who can fluently speak the languages of both people and technology, blending technical expertise while interacting effectively with customers and clients, staff and executive management.

CORE COMPETENCIES

• Project Management.
• Vendor Management.
• Experience with regulatory compliance HIPAA, HL7, 21 CFR Part 11 and SOX .
• Implemented Customized Solutions for business critical applications.
• 24/7 Global Production support for R D IT applications.
• Hands on experience applying patches, install, upgrade and test application software.
• Cloud computing and cyber security
• Database Administration, Conversion, Analysis, Data, Warehouse and setup clinical studies, MedDRA and WHO Drug dictionaries.

EXPERIENCE AND ACCOMPLISHMENTS

Sr Manager, Informatics

Confidential

• Infinity is an innovative drug discovery and development company dedicated to discovering, developing and delivering best-in-class medicines to people with difficult-to-treat diseases.
• Project Lead for
• Central Repository for Infinity Clinical Information Tracking CRICIT upgrade: CRICIT is a repository of clinical study results for analysis and reporting from a number of disparate data sources such as Medidata Rave EDC, Covance, etc.
• Defined project scope, goals and deliverables utilizing project methodologies.
• Developed Master Validation Protocol, Installation Qualification, User Requirement Specification, Functional Specification and support documentation.
• Application upgrade architecture definition, programming specifications creation and implementation.
• Project Lead for below projects and responsibilities including defined project scope, goals, deliverables, installation and data migration.
• Upgrade Spotfire V6 application
• Upgrade Argus safety V6 application
• Upgrade SLIM application
• Pilgrim saas based Quality Management application
• Implemented image based SAN backups for Oracle databases.
• Setup Couldara sandbox environment for BIGDATA analysis
• IT SOP GAP analysis
• Executed several change controls for CRICIT and ARGUS Safety for patches and other maintenance work.
• Managed the global technical support operations for all Infinity databases.

Principal Consultant

Confidential

• Genage is a Cambridge based software development and services startup company, developing IT applications for the healthcare and life science industry.
• Project Lead for Cloudcoder CMED application project. Cloud coder is a cloud based medical dictionary management system for MedDRA and WHODRUG dictionaries.
• Defined project scope, goals and deliverables utilizing project methodologies.
• Analyze regulatory clinical, safety data and business process requirements to map CMED infrastructure design.

Technical Project Manager

Confidential

• Managed the global technical support operations for Drug Safety AERS46 , Clinical data management OC4.5.3, RDC,TMS,eLoader and CRF Track and Product complaints applications AERS45 .
• Directed the team on technical support activities for OPA users as a 24/7 basis which included issue escalation management, training, delivery, and technical document development. Responsible for root cause analysis, managing risks and communicate progress to senior Biogen leadership on a regular basis.
• Led the effort to advocate and implement process improvements to reduce the time to process a help desk request from 5 days to 1 day.
• Established new support queues resulting in reduced escalations by 20 and drive double-digit increase in customer satisfaction while developing key contributors to increase technical expertise, achieve business goals, and exceed performance standards.
• Developed an internal R D IT support portal using SharePoint platform that provides an integrated searchable knowledge base ,resource schedules and This allows the helpdesk service group to be more self-reliant.
• Led IQ,OQ,PQ validation testing for Clinical Integrated Data Repository CIDR project including integration/interface with Drug safety ,clinical data and Medical coding databases.
• Tech lead for the data management outsourcing projects including EDC support.
• Analyzed infrastructure, support requirements and installed in sandbox lab as part of readiness assessment for Argus safety system.

Clinical DBA

Confidential

• Technical Lead providing technical support, administering system testing and UAT test script execution for the OC4.5
• ,TMS 4.5 ,MedDRA and WHODRUG load and SOP development projects.
• Created report functional specifications, design specifications, custom report framework to add new reports in the OC application.
• Verify backups and error logs on the servers and troubleshoot any failures, alerts or opened trouble tickets.

Sr Program Manager

Confidential

• Led Performance testing project for Argus safety, Analyze and prepares test strategy and cases for the performance / Load testing benchmarks and capacity planning. Managed the testing and validation effort.
• Production support for clinical and safety data users on change control requests, problems and enhancements.
• Generated several ad hoc reports to Drug safety, Clinical, CTMS and medical coding group.

Clinical Programmer Consultant

Confidential

Global clinical database setup, EDC study setup, eCRF development, edit check programming based on CDISC, CDASH standards and production support.

TECHNICAL SKILLS

Cloud computing,HPC:HP UX, Sun Solaris,Linux,Windows and Linux cluster,Active Directory,SharePoint,Citrix,:C, SQL, PL/SQL,HTML5,XML,Java, jQuery, Ruby and Unix Shell Script:VMVARE :ORACLE x, mysql, nosql and Big data:Oracle Clinical, RDC onsite, TMS, AERS, Argus safety ,e Loader,LSH , Ireview,B.O, cognos,CRF Track, CIDR Clinical Data Repository ,SAS,CTMS,Siebel CRM, Open CDISC, LIMS , TrackWise :Microsoft Office Suite, Visio and Microsoft Project