• Creation of timelines, including cross functional assessment of feasibility and presenting to the client to ensure expectations and corporate goals are met• Escalation point for critical issues and oversight of CAPA development• Work with individuals to improve overall team dynamics • Contribute to proposal development and participate in bid defense meetings • Presentation during client meetings including creation of agenda and meeting minutes• Collaborate with Project Management team to develop and implement processes that encompass CRO international presence as a basis for further SOP development• Accountability and responsibility for overall global clinical trial activities as well as oversight of the CRAs and study progress from point of trial start-up • Responsible for trial Risk Assessment Categorization Tool (RACT) development and maintenance• Working with Project Management team to troubleshoot and optimize EU trial budget template • Responsible for coordination of team to ensure compliance with trial timelines during each phase of trial

• Selected by the Decentralized Trials and Research Alliance (DTRA) Leadership Council to serve as a Co-lead for their 1st Initiative Group• Act as Clinical Operations Manager / Project Lead for smaller studies. • Mentor newer Clinical Operations Managers• Assist with interviews of job candidates. • Manage clinical operational aspects of clinical trial activities to ensure timely, high quality and profitable delivery• Track metrics for clinical site performance, including regulatory submissions, patient recruitment and progress to study deliverables and timelines• Coordinate with Client on site selection, IRB submissions, site initiation and close-out planning• Conduct vendor and resource selection and/or competency assessments and perform accompanied site visits as per Bionical-Emas SOPs • Track monitoring visits and related expense reports; review monitoring reports, ensure finalization per required timelines and escalate issues and/or trends• Provide input into, review and/or develop study related materials such as study plans and manuals, eCRF forms and completion guidelines, protocols, patient informed consent documents • Oversee protocol deviations collection and tracking process; review protocol deviations and data listings to ensure reliable quality data are delivered; escalate issues and/or trends • Coordinate the negotiation of site budgets within guidelines, and provide oversight for site payments per contracts • Manage clinical Trial Master File and provide oversight to TMF Administrators to ensure compliance with required regulatory and GCP quality standards and consistency with Bionical Emas SOPs

Interview job applicantsInvestigator Meeting presenting and planning (presentation and logistics)Process Improvement Committee member for Database Closeout Process, Informed Consent Template Language, and development of Training Programs.Creating and reviewing study documents including the Study Manual, Monitoring Plan, CRF Guidelines, Subject Materials and Informed Consent Forms. Review of protocol prior to study start and edit check specifications. TMF, CTMS, and Study Website creation and maintenance.Management of sites through study start up process (complex ICF development, IRB submissions, and Essential Document Reviews).

Review of company wide CAPA responsesUpdate of company SOP Work Instructions as part of CAPA responseSOP Gap/Risk Analysis for Preferred Client Renewal Mentoring of new to company/study employees (including those with noted performance issues)Personally requested for project level database reconciliationsCoverage for Functional Manager while manager is out of officeCompletion of standard CRA tasks (PSSV; SIV; IMVs; COVs; site management)

Mentoring and performance review of junior CRA staff new to the company. Providing guidance, constructive criticism, resource for study or system questions.Participated in 7 database locks in 5 yrs of monitoringCompleted start up activities on 4 studiesAssigned to pivotal, concurrent studies, managing site loads of up to 30 Specializing in working with highly difficult site staff/situationsProficient in identifying inefficiencies in processes and SOPs, presenting solutions, and implementing Created a program to allow for greater cost effectiveness for performance, training visits, and networking of traveling staff

Conducted Pre-Study Site Selection / SIV / IMV and COVsReviewed pharmacy documentation in order to assess IP accountability, dispensation, and complianceAssured that site personnel, including Principal Investigators, conducted the study according to the protocol, appropriate SOPs, ICH-GCP guidelines, as well as local regulatory requirementsProvided Protocol training to Site Personnel, including study procedures, conduct, site obligations, documentation, Case Report Forms and vendor management.Verified the appropriate documentation of the Informed Consent process for each study subjectAssured that all applicable regulatory requirements were being met by the investigator's sitePerformed Essential Document site file reconciliation, including collecting new Essential Documents as required

Management of investigator payments & quarterly cost predictions on study with more than 80 sites Identified inefficiencies in processes, escalated in an effective manner that lead to solutions. Assisted in creation of reports, automated forms, new equipment, and increased use of technology that reduced cost.Assisted Project Management in contacting sites during enrollment effort to determine barriers in inclusion/exclusion