My greatest accomplishment was completing the Medrio Designer Certification training and led the team to design a phase I database in-house; programmed edit checks; data validation specifications; and create CDM startup documents during the process. • Perform Sr. CDM responsibilities for 2 other phase 1 studies in study startup and conduct.• Provide weekly metrics reports to sponsor and DM QC in eCaseLink, • Obtain sponsor approvals for CDM Documents and store them to the eTMF. • Create lab data transfer agreements and reconcile lab data with database collection entries.

My greatest accomplishment was completing the IBM Clinical Development Design training and programming database from an approved protocol with the first 6 months of employment. Lead multiple phase I & II studies from protocol approval to database lock. Using IBM Clinical Development, create eCRFs; Data Verification Specifications (DVS); Data Transfer Agreements (DTA); Editcheck Programming; Cognos Smart Reports; External lab data reconciliations; and provide CDM deliverables to sponsors and CTM Team. • Locked single and multi-dose database parts for 2 databases• Start-up a phase II study• Troubleshoot CDM issues for work arounds and solutions. The one that I am most proud of was designing the unscheduled visit page that only includes the repeat assessments instead of everything. This saved the site and DM from having to close unnecessary queries. • Program standard metrics and medical coding reports to the sponsors

Provided oversight and advice to the Clinical Trial Management team regarding CDM integration activities and deliverables. Manage and resolve data management issues identified by the CRO; Biostats and Safety Team. As a department of 1, I am most proud of creating 27 CDM SOPs to support data management standards and best practices as well as documentation of Oversight at the CRO and vendor levels. And pooling 9 prior studies’ data to update the Investigational Brochure to support the New Drug Application (NDA). • Performed startup for an ADME, phase 1, II, and III studies; Conduct and locked 2 others. • Collaborated the programming of ADaM and SDTM datasets using CDISC standards and performed QC of the define.xml files prior to database lock. • Collaborate with Business Development and Safety to update the Investigator Brochure (IB) and Develop Safety update Reports (DSUR) reports.

Collaborated with sponsors and stakeholders to effectively manage the planning and execution of Data Management (DM) projects. Participated in business and bid development; supported bid production; assign tasks and responsibilities within DM; delivered timely and accurate results and supported the needs of the sponsors. • Followed CDISC compliance, assisted with SDTM dataset creation; Used SAS and programming macros for design and UAT. • Supported Oncology phase 1 & III study conduct and database locks.

Online Consultant (hobby)Provide mobile marketing options to small businesses to make them competitive with larger online storefronts. Create mobile websites and provide text marketing to create new and repeat business. Created this to generate income during the economic downfall.

Short-term contract to perform data review and query generation; review and define edit checks to be programmed for the project; Track study progress and issue status reports; Update database errors; Perform medical and medication coding; Import external data; • Identify achievement milestones for the project manager• Completion of quality control measures for finalization and transfer to the sponsor.

Main point of contact with the Clinical Study Teams at MedImmune, LLC; responsible for ensuring that all activities are completed on time for assigned projects by allocation of tasks and effective management of relevant stakeholders and data management centers for programming and biostatistical teams for 10 Oncology studies. • Project management of the end-to-end service for SAS tables, figures & listings. Manage team deliverables.• Compared SAS Programming tables against EDC database for accuracy prior to submittal.• Participate in interdisciplinary teams’ meeting to address Biostat concerns of clinical trial management.

Provide contractual data management support for both paper and EDC clinical studies utilizing SAS, Medidata Rave, or Oracle Clinical applications. • Met study timelines for generating and updating sponsor-initiated queries in preparation for database lock. • Participated in a high profile sponsor initiated Pre-FDA 100% critical field audits• Evaluate project scope, timelines and deliverables from project initiation to close out for one study for archive.

My greatest accomplishment was travelling to Belgium and training with GSK’s proprietary system Programmers and becoming train-the-trainer certified. Provided DM EDC systems training and support for Antigen Specific Cancer Immunotherapy (ASCI) clinical vaccine studies for North America (NA). • Met start-up timelines for training and EDC system upgrades for thousands of NA ASCI users. (CRAs, site staff and Investigator meetings)• Created extensive training presentations that I provided to the CRAs, so they were prepared to train sites whether they had access to the internet or not.• Operated as the local helpdesk and the second level support for all North American study staff, monitors, and site users, which reduced the number of global helpdesk calls from North America.

Managed CRO activities initiating, planning, executing, controlling, and closing for various phase I, II and III vaccine research protocols. Tasks included database and eCRF designs; CDISC annotations; DM Plans; Guidelines; validation checks; data transfers; and database locks. Also liaised with Clinical Project Management across 5 US and Canada locations.• Researched and trained staff on new technology to process improvements. Trained on Oracle Clinical and Inform to support clinical project development and participated in the UAT on these platforms.• Implemented multi-site teleconferencing to create virtual meetings to accommodate remote locations.• Completed Programming I basics at the SAS Institute in order to convert historical data from Excel spreadsheets into SAS data sets for statistical analysis & reporting. I also programmed tables and listings to support the Clinical Study Reports and Regulatory submissions.• I was most proud of creating an Access database to collect Cardiography data for a small pediatric study. I purchased 3 books and learned to program this database with edit checks and all. During the UAT, the CTM team was not able to break it.

Supervised 10 direct reports to support 11 phase II and III vaccine protocols. Acted as Senior Manager for 11 months; during which time hired; fired; budgeted; recruited; performed and conducted performance evaluations; interviewed and trained data management personnel while the primary POC for DM responsibilities. Three days after starting as a DM Associate, I was informed that the Sr. Manager of DM was leaving, and she had 3 weeks to get me up to speed to be Acting Sr. Manager of Data Management. My performance earned me the Manager role.• Initiated Migration from 3 Software applications into 1 data warehousing software and reduced data verification forms (DVR/queries) time by 66%. • Migrated to Clintrial 4.X CTM Software and was responsible for System Administration, Database Design, and software training. After meeting with the CDISC task force, Initiated the programmers’ migration to CDISC standardized variables reporting in SAS and Clintrials for uniform FDA compliance reporting.• Created training programs; DM Plans; Protocol Guidelines and Standard Operating Procedures (SOPs) to ensure that all data management activities were standardized and fully documented. • Trained in all Clintrial Modules, Oracle and Advanced PL/SQL for writing queries and maintaining database structure.• Most proud of how I streamlined the processes so that we could support 11 studies with 1 Data Manager.

Because my previous work experience was Environmental Data Management; I was not offered the CDM role as I originally applied. My greatest achievement was leading the cleaning and organization of a phase IV study that had been ignored for almost 10 years. I collaborated with the Programmer to code close to 700K concomitant medications that the auto-coding browser was unable to code. Performed data validation, query management, and medical coding across many therapeutic areas. (Oncology, CNS, Respiratory, Infectious Disease, Dermatology and more.)• Imported central lab data and verified reference range compliance. • Performed UAT on entry screens for paper CRF compliance with protocols and guidelines.• Created a bulletin board to record DM questions and answers to create consistency across study sites for global studies.• Worked with the IT team to install Y2K software on 400+ desktops and laptops to combat the foreseen data change issues.