Consulting Services include • Analyzing the strength of CTMS foundations starting with data integrity • Incorporating business processes into CTMS.• Supporting access to robust outputs that will assess progress, compliance, and metrics.• Preparing and providing end-user training to client personnel • Advocating business needs with the CTMS developers• Interpreting data to develop action plans to improve business• Defining and drafting proposed reporting solutions • Partnering with technical consultants in the deployment of business solutions• Ongoing support post Go-Live• Consulting support during implementations, data migrations, and integrations. • Ensuring CTMS is compliant with ICH E6 Good Clinical Practice Guidance• Recommending business solutions to maximize CTMS potential.

AbbVie, North Chicago, IL Jan 2013 to Nov 2019Senior Associate Clinical Operations Manager, US Site Support Systems Team Oct 2018 to Nov 2019Due to performance recognition, my management role was expanded to include the following responsibilities in addition to all assignments supported from Jan 2013 to Oct 2018. Initial team of 6 grew to 16 by May 2019 and were assigned to 6 unique team. 1. 10 FTEs - Review all Investigator documents uploaded to the eTMF to ensure all requirements are met. NOTE: QC review backlog of > 28,000 documents from prior dept was resolved by Oct 2019. 2. 2 FTEs - Submit CDA/CSA requests to Outsourcing for all US sites entered in the CTMS system.NOTE: Management confusion about process when transitioned from another dept. I created a flow chart defining CTMS fields were required to automate the process and identified noting the request status. 3. 1 FTEs - Enter all US sites in CTMS adhering to data entry standards and business process requirements. 4. 1 FTEs --Notify sites that have IP expiring and send updated labels to sites if expiry date is extended. 5. 1 FTEs -Program questionnaires for studies in start-up for sites, products and countries, plus ad hoc requests.6. 1 FTEs - Programmed 8 global customized metrics and listing for SMM which I created during Jan 2013 – 2018.

1. Managed a team of 8 CRAs. 2. Began trouble shooting the integrity of metrics created by other groups.3. Created and supported global metrics for issues, visit reports, CTMS entry completion, CTMS site issues.4. Provided global and cross-functional support for the CTMS development.5. Researched and reconciled system issues with SUSARS (Safety Letters) sent to sites in error.6. Facilitated global cross functional discussion for CTMS Company Personnel Assignments.7. Defined business processes to align with CTMS entries set business expectations and data integrity.8. Assigned to the Global CTMS Business Process Owner team.9. Investigated business issues supported by CTMS entries to determine cause of errors. 10. Jan 2014, 100% dedicated responsibilities for global systems and metrics

• Hired to support CTMS due to prior experience with Monitoring Director at TAP and Takeda. • Assigned and drafted business processes for the new dedicated remote monitor role. • Monitor investigational sites participating in clinical studies to ensure protocol compliance, subject safety and adherence to FDA/ICH regulations. • Defined business processes, wrote training materials, and provided user support for CTMS. • Managed the Regional CTMS SMEs who provided additional support for their region’s CRAs.• Participated in new CTMS initiatives such as upgrades, automating follow-up letters, MemStick, etc.• Participated in user acceptance testing, Global Core Team Meetings, and roll-out support.• Participated in the development of revised visit report (VR) templates (rolled out in Jul 2009).• Developed metrics for VR completion, monitoring days, and monitoring interval compliance.

Provided professional services in the development of Takeda's Clinical Operations/Site Operations Clinical Trial Management System using Oracle Siebel.  Developed business processes for entering sites, site personnel, site visits, etc.  Facilitated the development of the visit report templates  Developed metrics for VR completion and # of monitoring days per CRA  Implemented quality checks to ensure Site Ops business processes were followed.  Led the Siebel Business Group meeting to discuss system needs, enhancements, etc.  Provided Siebel training and Medidata training for all Site Operations personnel  Managed the Siebel and Medidata SME program who provided additional user support  Partnered with Fedex to import Seibel data into Fedex website for mass printing of airbills  Developed Siebel public queries to assist Site Ops with quick assessments of study information  Managed 3 Data Quality Analysts contractors whose responsibilities were quality data entry into Siebel and management of the Medidata user accounts for all US sites

 Provided monitoring support for investigators participating in clinical studies  Ensured the site’s compliance to the protocol and FDA/ICH Regulations  Conducted source document verification, drug accountability, review of essential document binder.  Evaluated sites’ qualification for participation in clinical studies

Provided professional services in the development in TAP's Clinical Operations Clinical Trial Management System, Oracle Siebel. Services included working with business to determine system needs and propose business processes, work with Information Services to communicate and develop Siebel to meet business’ interests. Created training materials, provided training, and provided support to users.