Provides technical support and project leadership to all technology projects. Serves as the Subject Matter Expert (SME) for technical responsibilities, system functionality, processes, infrastructure, data, troubleshooting, system support. Serves as a liaison with the business units, functional leads and technology services within all areas of the company. Leads technology project implementation, ensuring that the quality of interactions and communications across the project are consistent with the business unit and department expectations.

• Drives clinical system implementation projects, overseeing key documents like Risk Assessments, UAT, and training materials.• Designs and maintains implementation plans, ensuring comprehensive training for clinical technology systems, fostering user confidence.• Instructs and guides both new and existing employees in utilizing systems, ensuring smooth onboarding and regular system update training. Disseminates monthly technology updates across the organization.• Guides and mentors new and existing employees on clinical technology, facilitating monthly technology updates.• Chairs project meetings, effectively communicating with stakeholders to ensure project success.• Serves as Salesforce Administrator, orchestrating testing, user experience optimization, and acting as a liaison between users, executives, vendors, and development teams.• Collaborated across functional groups to elevate data quality and enrich the user experience within Salesforce. Identified exact business requirements, conducted user and system analyses, and delivered data-driven recommendations.• Manages vendors for clinical technology systems and reports KPIs for process improvement.

• Designed and delivered CRC Training Program for new coordinators, including work instructions, WordPress website, and MS Teams group.• Tracked multiple aspects of the study and communicated information to the study team, escalating issues as appropriate. • Responsible for site support during study start-up and close out. Communicated with site staff regarding the collection and status of essential documents, study supplies, mass communications, enrollment survey follow-up, and other study related information and actions.• Assisted study team in collection and tracking of essential documents, IRB submissions, procurement and shipment of supplies to sites. • Aided in vendor management.• Assisted with review of both internal and external documents, including essential documents and IRB applications. • Maintained clinical trial master files and kept all documentation current. Conducted periodic TMF file reviews to ensure completeness. • Provided meeting agendas, minutes and action items for study related meetings.

• Mentored and trained new in-house and remote employees in the implementation of tasks and responsibilities within their job description.• Responsible for the tracking, measurement, and evaluation of project metrics to implement efficiencies. Suggested recommendations for outliers found in output.• Worked in conjunction with Project Manager to formulate and maintain a project specific training matrix. Communicated with training department to ensure matrix is uploaded into LMS.• Assigned and tracked study team training to ensure all members are compliant in their study specific training. • Responsible for coding project specific invoices and submitting for approval.• Ensured all project team members have the necessary system access needed to effectively contribute to the team and complete all functional area responsibilities. • Drove the review of the country and study level TMF to ensure that all necessary documentation is present and correctly filed.

• Oversaw setup, maintenance, and closure of project files and study data, to include the Trial Master File, regulatory documents, enrollment data, adverse events, IRB submissions and approvals, and data queries within various systems.• Efficiently prepared and circulated meeting minutes, coordinating action item follow-ups to resolution for both internal and external meetings.• Facilitated communication within the team and with site personnel, ensuring Project Leadership and CRAs were well-informed about site and study progress. Liaised with sites for critical updates.• Maintained and reported on the currency of clinical systems, including Vendor Systems, CTMS, and TMF.• Vetted and approved invoices and site payments.• Orchestrated compilation, shipment, and monitoring of Investigator Site Files and Rater Training Kits.• Played a key role in vendor management.• Tracked project metrics across multiple functional areas, contributing to informed decision-making.

• Mentored and trained the Clinical Trial Associate (CTA) Team, creating an entry-level CTA training program.• Conducted candidate interviews, offering valuable feedback to management for optimal candidate selection.• Efficiently organized study documents and materials, ensuring alignment with Project and Sponsor SOPs.• Independently identified, managed, escalated (when necessary), and resolved site issues, demonstrating proactive and effective problem-solving.• Supported the development and maintenance of study-specific Site Management Plans and TMF Specification Documents.• Collaborated closely with CRAs and sites to collate essential TMF documentation throughout the study lifecycle.• Conducted ongoing review of documents filed in the Trial Master File to ensure accuracy and completeness. • Devised pertinent tools, templates, and processes to streamline the collection and monitoring of study documentation.• Updated ICF templates based on protocol amendments, completing ICF regulatory checklists to ensure regulatory compliance. • Coordinated documentation submissions to Central IRBs and collaborated with local IRBs to secure approvals and proper eTMF filing.• Tracked and organized internal team study specific training.• Provided regular project status updates to the project team and study Sponsor. • Processed IND/IDE safety letters.• Facilitated distribution of study documents to sites and study team throughout the study’s duration.

• Provided comprehensive support and served as a valuable resource for Nuventra's clinical and regulatory operations teams.• Maintained precise and up-to-date clinical operations tracking documents, ensuring accurate project monitoring.• Prepared, handled, distributed, filed, and archived project documentation and reports.• Ensured the accuracy and completeness of study files through detailed review processes.• Oversaw the preparation, review, and maintenance of tracking information pertaining to Clinical Trials Supplies.• Played a pivotal role in the preparation and review of regulatory documents for submission readiness.• Coordinated project team meetings, handling scheduling, agenda/material preparation, and minutes distribution.• Managed and meticulously maintained Trial Master Files for multiple clinical studies, adhering to the DIA Reference Model.• Established direct communication channels with clinical study sites, prioritizing site activation and ongoing management.• Conducted thorough reviews of Informed Consent Forms for multiple sites, ensuring submission for IRB approval readiness

• Demonstrated leadership as Department Chair, guiding a team of educators in aligning with School District objectives and implementing them effectively.• Crafted inventive presentations and supplementary materials that propelled students towards achieving growth targets.• Managed diverse class sections, ensuring active engagement, material retention, and meticulous data tracking.• Thrived in a fast-paced and challenging environment, showcasing adept problem-solving abilities.• Analyzed testing data to direct instruction. • Employed innovative approaches to motivate groups of students, fostering ownership of learning while building trust in my support for their success.• Maintained commitment to professional growth through ongoing development opportunities.• Directed Project Management initiatives for technology integration within the school, showcasing organizational and coordination skills.• Held the role of Grade Level Technology Contact, facilitating seamless communication and implementation of technology-driven strategies.