• Led the user acceptance testing (UAT) of newly updated clinical trial databases; perform and document the outcome of UAT tests to verify the accuracy of the database structure and validation of edit check programming• Performed SAE reconciliation, querying for inconsistencies or requesting guidance from Safety• Prepared and/or reviewed trial level documentation such as CRF completion guidelines, Data Management Plans, Data Validation Plans and Data Transfer Plans• Performed Site and User administration for EDC systems• Study Team Lead for Sponsor Meetings

• Identified subjects and developed timelines to collaboratively perform data management review approaching database lock• Drafted and updated specifications for targeted source documentation validation• Created reports and work instructions to successfully integrate manually enrolled subjects with newly configured Randomization and Trial Management software

• Vendor/CRO/ lab management for multiple complex studies• Confirmed data transfers and reconciliation occurred per Data Transfer Agreements• Managed and lead Data Review meetings according to Data Review Plans

• Developed the Data Management department to include SOPs, forms, and working documents• Wrote Data Review Plans, Data Management Plans, and eCRF Completion Guidelines• Developed and conducted User Acceptance Test scripts, testing and approval processes• Oversaw EDC programming updates and implementation• Designed eCRFs using CDISC standards• Conducted thorough data review for Safety analysis datasets• Created query metric reports that ensured quality data review and monitoring• Reviewed Safety analysis SDTM tables and provided feedback to the statistical vendor

• Oversaw the programming activities for database build on the EDC platform ClinCapture• Managed the execution of globally-based clinical studies per contract, from initiation through closeout, providing data management support• Ensured that all clinical study management and programming deliverables were completed to the Sponsor's satisfaction, while ensuring quality deliverables were on time and within budget and in accordance with SOPs, policies and practices• Coordinated efforts of cross-functional project teams to support milestone achievement• Served as primary project contact with Sponsor to ensure communication was maintained and study development timelines were adhered, including the need for change orders• Lead problem solving and resolution efforts to include management of risk, contingencies and issues

• Identified and documented areas for improvement through either process improvements or technology enablement• Orchestrated cross-functional review of SRB documents and specifications, captured feedback and implemented changes to Standard Document Specifications• Provided clinical data standards and standards governance solution assessments and recommendations for standards content, processes, and tools• Provided clinical data process and standards subject matter expertise to database build and implementation projects• Established and managed project timelines, tracked progress, cascaded updates and changes to the review board• Identified and managed project related issues and risks

• Lead eCRF and edit check study team review meetings; eliciting and incorporating team feedback with close adherence to the Protocol • Coordinated data management workflow for assigned projects, including Database build in Medidata RAVE • Participated as the data management expert, providing specific expertise on eCRF design and specifications for a large, international study with a tight build timeline• Wrote report specifications to reconcile data from multiple databases (integrations of the EDC system with other auxiliary systems)• Consulted with subject matter experts to ensure lab data that will be correct, complete, logical and ready for transfer and/or statistical analysis• Wrote User Acceptance Test scripts, orchestrated testing and updated systems based on test findings.

• Participated in cross functional meetings and drove initiatives to ensure the delivery of milestones and timelines for clinical trials• Managed relational databases, created and executed overall plans for data reconciliation• Determined data standards appropriate to the Sponsor and image and data transfer plans according to study objectives and client needs• Created and reviewed blinded and adjudicated imaging datasets for data consistency• Provided mentorship to Jr. data managers• Developed and taught SCDM (Society for Clinical Data Management) educational materials for Data Management classes

• Complete study start up activities including CRF design, CRF annotation and Database Specification/Edit Check Specifications for complex oncology protocols• Design, perform and oversee UAT specific to study • Thoroughly document Data Plans including Data Management, Data Transfer, Data Integrity and Data Review• Lead and review team Data Reviews to identify, track and resolve data queries to ensure study timelines and data quality expectations are met• Working collaboratively with Drug Safety to code and reconcile discrepancies for medications and Adverse Events• Managing vendor relations to ensure complete, accurate and timely transfers of clinical data• Provide up to date CCGs and ongoing training for CRAs as needed

• Developing study and annotated oncology case report forms• Working collaboratively to ensure clean, timely data in the database lock process• Prioritizing study needs in accordance with analysis timelines• Thorough, accurate capture and transfer of data • Entering clinical data in Access database with accuracy, auditing for inconsistencies, querying discrepancies

Aggressive, self-starter sales position gathering mortgage leads through networking, Wells Fargo referral and executive relationships. Top volume sales for branch June 2004. Superior customer satisfaction rankings throughout tenure (5's on a scale of 1 to 5). Held home buying training events and financial seminars, in-branch sales events and actively participated in networking groups. Exceeded sales goals in all facets, creating demand and closing deals. Provided finance solutions that aligned with the customer's short term and long term financial objectives. Keen ability to articulate sales strategies to senior executives and colleagues.

Assisted in marketing and sales of large condominium site in Bellevue, WA. Chaired meetings of sales team, developer and construction. Project management, marketing and event planning. Solid presentation skills. Copy writing, ad placement, editing. Demonstrated negotiation skills, ability to be a self-starter, and a strong closer. Guerrilla marketing campaigns included sales events geared toward first time homeowners with an interest in container gardening. Increased condominium site's awareness through local garden clubs. Permission marketing campaign to sell additional parking spaces to existing condo owners resulted in all units sold within 2 weeks.