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Software Engineer Resume

San Jose, CA

TECHNICAL PROFILE:

  • 5+ years experience managing Global Clinical Trials in the Pharmaceutical Industry
  • 15+ years experience as a Software Engineer in the High Tech Industry
  • Strong Programming language skills including SAS and High Level languages
  • Demonstrated Ability to identify gaps in databases and suggest solutions to overcome inconsistencies
  • Strong background and experience working with PC Windows and Office Suites software
  • Collaborative team member and can work independently with minimal guidance
  • Clear, concise communicator and instrumental in fostering productivity
  • Excellent Multitasker and ability to prioritize study, site issues
  • Ability to apply knowledge of clinical trial process and regulations (FDA, ICH, GCP regulations, Genentech SOPs and guidelines) to ensure appropriate study conduct.
  • B.S in Electrical Engineering, M.S in Biomedical Engineering and Certificate in Clinical Trials Design and Management

PROFESSIONAL EXPERIENCE:

Confidential

Clinical Trial Associate (Oncology & ClinPHARM Studies):
Confidential, (Feb 2011 - present) Confidential, (July 2011 - present):

  • Partnered and Assisted Team members with the migration, setup and maintenance of studies from Trial Works to SEIBEL CTMS systems
  • Collaborated with CRO to setup drug shipment and collect regulatory documents by conforming to GCP guidelines and enabling Site Activation on July 21st, 2011
  • Currently acting as a Single Point of Contact between CRO and EDC, IWRS partners regarding user access and site training related system issues
  • Currently responsible for updating CTM, CPL by conducting Money Meetings utilizing appropriate business system reports and metrics

Confidential, (October 2009 - Feb 2011):

  • Collaborated and partnered with PDIT to achieve smooth EDC / Trial Works integration by synching Trial Works Visit names with EDC Visit folders post EDC go live
  • Led the Cross-functional and Global Teleconference meetings to ensure smooth movement of Contracts per study timelines
  • Reviewed Informed Consents from Sites per the Genentech Informed Consent Checklist Guidelines
  • Worked with the Central IRB to obtain IRB approval of the aEGFL7 Phase 1b protocol for sites currently enrolling patients
  • Conducted regulatory and compliance oversight for multiple studies per Genentech SOPs and Working Documents
  • Partnered with Vendor Finance to lead the effort to migrate Site Payments to Automatic Clearing House (ACH) Wire Transfer payment method resulting in enormous cost savings
  • Led the migration of INDSR submission to sites and CRO electronically
  • Managed and successfully setup relationships with 3rd party vendors
  • Supported the team to achieve First Patient In (FPI) in 5 weeks post Protocol finalization
  • Achieved two site activations in 5 weeks after Protocol was finalized by ensuring timely collection of regulatory documents

Confidential, (August 2008 - Present)

  • Conducted Trial Works training of the CRO (US & Global) for the successful implementation of change in Site Payment process for both SHH4489g and SHH4476g Trials
  • Participated in UAT (User Acceptance Testing) of IWRS
  • Collaborated with PDIT to spearhead EDC/TW integration for SHH Ovarian Study by updating TrialWorks Visit Template and successfully conducting DATA MIGRATION
  • Wrote the INDSR Process Document for external distribution and internal tracking of IND Safety Reports by identifying process gaps and leading process improvement and training
  • Provided CRO with monthly Business Objects Reports for site payment reconciliation

Confidential, (Jan 2007 - August 2008)

  • Pioneered the Visit Occurred Payment Method for making Site Payments for ISTs which was later adopted by GNE studies with the Financial Management Initiative in TrialWorks
  • Collected and reviewed Regulatory documents from Sites
  • Worked closely with Contract and Budget group to start, track and close contract issues with Sites

Confidential, Mountain View, CA February 2006 to January 2007
(Contract ended due to no funding) Contract Clinical Study Coordinator

  • A Pilot Multi-Center Study Examining the Relationship Between Biomarkers and Rejection and/ or Calcineurin Inhibitor Toxicity (CI Tox) in Kidney Transplant Patients
  • Supported and oversaw 12 total and 5 Active Sites
  • Conducted Monitoring Visits to Sites (Stanford and UCSF) to ensure CRF data integrity
  • Reviewed and Updated Case Report Forms, protocols and SOPs using CLIA lines
  • Responsible for recruiting Lab Vendors and Nursing Agencies for execution of Clinical Study

Confidential, San Jose, California Mar 1999 to Mar 2004 (Left to work on clinical research certificate)

Software Engineer: Wrote driver in Linux C for diagnostics of the Adaptec FC-to-SCSI SAN Subsystem Ported NDIS 4.0 driver to NDIS 5.0 for Win 2K for Xpeed SDSL Adapter using the Microsoft Visual Studio, SDK and DDK 5.0 environment MITSUBISHI ELECTRONICS OF AMERICA, Sunnyvale, California 1994 to 1998 Applications Engineer: Partnered with Microsoft in the development of Windows 95 software interface for Memory and Network Cards Worked as a liaison between Microsoft and Mitsubishi Memory Card Design Group in Japan

Member of Cross functional team: Attended Global Product Meetings in Japan and worked with cross-cultural teams and external partners

Confidential, Colorado 1988 -1991

Software Design Engineer: Video Phone Wrote and tested diagnostic software to test custom designed Communications hardware Wrote & Documented Menu Driven SAS Software for Data Analysis

LEADERSHIP EXPERIENCE & CoMMUNITY SERVICE:

Confidential, 2011-2012: CO-CHAIR PROFESSIONAL DEVELOPMENT FORUM
Confidential, 2010-2011: MEMBER of NEXGEN LEADERSHIP FORUM
2011-2012: CurrentlySERVING as A MENTOR for SECONDARY TEACHERS AT THE
ISMAILI LEARNING CENTER
2008-2010: PRINCIPAL of ISMAILI LEARNING CENTER with A STAFF OF 11 DIRECT REPORTS, 30 INDIRECT REPORTS and 133 students
2010: LED and ORGANIZED TEENAGE BAND for PARTNERSHIP WALK to raise funds
for DEVELOPING COUNTRIES

Accelerating Anticancer Agent Development and Validation Workshop: Participated in the 2010 Summer Workshop which was held June 23-25, 2010 in Bethesda, Maryland. Participation in this Workshop is by invitation only.

EDUCATION
M.S. Biomedical Engineering
B.S. Electrical Engineering
Certificate in Clinical Trials Design and Management

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