Naoko Stearns

• On site at Comerica Bank, Sort and classify institutional and personal trust documents into categories for email, scan for appropriate departments and officers.
• migration of trust documents from personal decentralized folders into the centralized corporate repository
• Assist in communications between the retail banking and trust management functions within the organization

• Used two lead generation software to locate and contact property sellers and buyers.
• Learned how to complete various forms to complete required financial transactions.
• Researched local and regional markets to explore different segments of real estate markets in Florida.

• Oversaw the work of several CROs that produced raw CRF data, mapped SDTM data and the final analysis data for two cancer studies submitted for FDA.
• Supported clinical operations and pharmacovigilance teams by generating Patient Profile report.
• Monitored study recruitment numbers and proper allocations of treatment groups in the collected data
• Answered querries by medical monitor and statisticians during patient recruitment and data collection.
• Worked with the data managers to make CRFs more CDISC compliant.
• annotated imaging data of PET/CT scans for our CROs and internal teams.

• on site at Sunovion Pharmaceuticals, programmatically validated deliverables of work done by a CRO.
• Developed a tool to check clinical study data mapped by different CROs against the CDISC standard and generate non-compliance report for the pharmacovigilance group.
• used Pinnacle 21 to check CDISC and ADaM compliance of mapped clinical data and review the reports.

• supported multiple oncology projects to generate analysis data, tables and listings.
• migrated global utility programs from SAS windows environment to newly installed SAS Grid.

• Wrote SDTM and ADaM specifications for oncology projects
• Generated listings to reconcile Adverse Events data between the clinical data and safety data.
• Generated listings to reconcile lab data generated between the clinical and external vendor data.

• Onsite at Bayer Pharmaceuticals, supported Phase I-III oncology studies by programmatically validating internally mapped domains.
• Validated all cancer related codelists defined in the Unix environment against the definitions in the study protocols.
• Oversaw the mapped clinical data done by external vendors to check for the CDISC compliance.
• Reviewed final domain data ready to be submitted to FDA.

• As a compound programmer, oversaw the work, quality, deliverable timelines, resource requirements of external vendors that produced clinical raw and mapped data and specifications of phase I and II solid tumor studies.
• Generated data review listings for data managers
• Worked with the data management to document and resolve data and mapping issues.

On site at Bristol Myers Squibb in Connecticut, generated data and tables for manuscript for Medical Affairs group.

On site at Novartis Pharmaceuticals, generated analysis data by pooling 19 studies of laboratory data from Phase 1I to III, for a FDA submission of a new respiratory drug.

• On site at Hoffman La Roche in Basel, participated in two large phase III studies in hematologic cancer study drugs.
• Generated safety reports for Data Monitoring Committees.
• Annotated CRFs of a new phase I study.

• Supported the work of HIH funded Neonatal Intensive Care Unit coordinating center.
• Helped in the development of EDC from scanned CRFs parsed via PEARL programming and converted to Visual Basics for Access DBMS
• Tested the EDC system
• Developed website for muti-site coordinators.