Aperio Clinical Outcomes (formerly INNO Clinical Outcomes) provides full, customizable clinical research services across multiple therapeutic areas. More important, we offer what sponsors need most in today’s new world of healthcare: intelligence, honesty, and agility. We deliver comprehensive clinical research services with unmatched transparency.That’s why we chose the name Aperio — Latin for uncover or reveal.Aperio Clinical Outcomes. We make it clear.

• Manages a data management project• DM lead for internal/client team meetings and communication• Produces and reviews metric reports for internal/external project team• Ownership for project deliverables within DM scope of services including projections• Identifies roadblocks and provides solutions for completing project objectives in a timely manner• Reviews project budgets and staffing projections for data management activities• Provides training of other DM staff on project specific processes• When required as a single service contract, manages project financials and project management activities• Clinical Data and Query Review• Creates the Data Review Plan and the DM listings using ad hoc query tools• Issues queries and reviews query responses with the highest level of quality based in accordance with the Data Review Plan/Guidance document; including Manual Review (AE/CM comparison, Inclusion/Exclusion review, etc.), and Reconciliation (LAB, SAE, ECG, and other vendors)• Oversees System Development and Modifications:• Drafts the CRF design, edit check specification and DM listings• Facilitates clinical team review of system documents (CRFs, Edit Checks, Data Review Plan, etc)• Manages all database build and modifications (expectations for timelines, UAT, production release)• Creates and Maintains Documentation for the project• Data Management Plan, CRF Completion guidelines, Data Entry guidelines, Edit specifications, Reconciliation guidelines, and Report specifications• Database release documentation (blank CRFs, annotated CRFs, edit checks, configuration/workflow)• Project Specific SOPs/WPs (as directed by PM)

• Independently lead multiple, high volume and extremely complex studies within a development program. • Independently lead and/or efficiently perform, with quality, all data management activities within an assigned study. • Mentor junior level staff and peers on all associated tasks within a study or program. • Manage study activities and ensure quality of junior level staff assigned to projects.• Responsible for customer contact, functional and administrative oversight of projects assigned. • Participate in the development and implementation of processes, procedures and training for the data management function. • Assign, review and check the work of others performing similar duties. • Work with global team in multiple time zones.

Define study timelines and track progress to ensure compliance, while maintaining data quality.Liaise with Sponsor, site personnel and vendor partners while providing exemplary customer service.Create, review, and finalize case report forms and data entry screens.Database design, documentation, and testing.Create and test edit check (data validation) specifications.Perform data review, document data inconsistencies, and discrepancy administration.Manage coding for adverse events and medications.Perform Serious Adverse Event reconciliation at defined intervals.Produce listing for Sponsor and vendor partners.Provide support and training for clinical research personnel.

Continue to perform the duties listed as a Business Systems Analyst for Experis.Partnered with stakeholders and vendor to determine and publish requirements for enhancements. Wrote test scripts for defect and production enhancements.Identified, analyzed, and troubleshot process and application gaps.Designed, tested, and implemented Access database for ticket tracking.Presented analysis to stakeholders for prioritization of business objectives, requirements, and gaps.Served as company certified communication and policy/procedure author for my team.Wrote technical documentation for application functionality for Collections Line of Business. Compiled documentation for all lines of business and coordinated maintenance.

Assigned to SunTrust Mortgage.Tested defect and production enhancements installed during scheduled deployments.Troubleshot application default and enhancement requests from users.Administered User Access for applications with over 1000 users.Standardized and documented user access process and request form.Defined and documented monthly user security reconciliation to disable inactive user accounts.Provided technical and non-technical support to internal resources for application issuesStreamlined the flow and efficiency of incident tracking.Supported and assisted in capturing accurate, clear, and detailed technical system requirements.Delivered supporting documentation and assisted in internal audit finding remediation. Remediation resulted in rapid removal of over 200 inactive accounts to minimize the risk of application security breach.Worked with stakeholders to determine current processes and published technical procedures and SOPs.

***Manager, Clinical Data Management (Feb 2006 – Dec 2010)Evaluated and selected Electronic Data Capture (EDC) vendor modernizing data management process. Lead successful pilot EDC study.Collaborated with project team for clinical protocol and data collection systems design and implementation for data necessary to analyze safety and efficacy of compound.Defined format of data collected by external sources for integration into clinical data analysis.Utilized and maintained database conventions facilitating rapid build, testing, and programming.Managed workflow and data entry personnel to meet established timelines with quality deliverables.***Clinical Data Manager (Aug 2005 – Feb 2006)Developed and employed Work Practices and Standard Operating Procedures regulating processes.Created and executed quality plan by writing and enforcing quality control specifications and manually reviewing the data resulting in less queries from internal customers.Established and implemented CRF library automating form development and presenting a common format to collect more consistent data.Coded adverse events using MedDRA allowing grouping for analysis.

User Acceptance Testing and User documentation for client studies.Addressed client requests and provided support to the internal Project Team, extended services partners and sponsor Project Team to meet defined timelines.Maintained study specific documents and posted to appropriate document repository in accordance with standard procedures.

***Clinical Database Programmer (Oct 2001 – Feb 2003)Built, tested, and maintained clinical database to facilitate efficient processing of clinical data.Standardized checklists, flowcharts and work practices resulting in consistency and reduced entry errors.Utilized Cognos Impomptu report writer to produce ad hoc listings for safety and project team reviews.***Clinical Data Coordinator III (Nov 1999 – Oct 2001)Entered and reviewed data, querying inconsistent or questionable records ensuring data integrity.Presented form completion and potential data collection issues at Investigator Meetings resulting in more accurate data gathering.

***Manager, Clinical Data Management (Jul 1997 – Nov 1999)Reviewed data, tables, and listings for accuracy and consistency then performed quality control of Final Study Report.Created and taught curriculum for regular training course for entry level team members.***Clinical Data Management Coordinator (Dec 1996 – Jul 1997)Worked with project team to detail key information and timelines producing complete data sets for analysis.Implemented and administered database development training for data processing personnel providing a springboard for further growth within the organization.

***Clinical Data Specialist I/II (Apr 1993 – Dec 1996)Learned data entry and data processing activities on multiple active clinical studies within a program.Actively participated in project team to further trials for assigned compound.***Secretary I/II (Sep 1991 – Apr 1993)Secretarial resource for three groups within two departments.