Yvonne Ebere Henshaw

• Act as the primary point of contact supporting the planning and execution of sponsored clinical trials (phases I-IV). • Manage study start-up and developed clinical study plans, Investigator site templates. • Prepares and presents materials for Investigator meetings and CRA training. • Reviews and approves investigator site payments. • Reviews and approves CRA expenses and timesheets. • Provide leadership and site relationship management to Clinical Trial Partner sites to support the optimization of key processes and ensure critical trial milestones/timelines are met. • Support the Feasibility process to ensure site selection is completed per the expected timeline. • Review trip reports and manage CRAs to ensure quality and compliance per annotated trip report. • Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs • Provide training as needed for monitors and any other activities that support site readiness to recruit, and inspection readiness. • Manage and lead cross-functional study teams, including vendors. • Support the project manager/director with establishing study milestones and accurate tracking. • Confirm that the eTMF is correctly set up and maintained appropriately throughout the trial. • Participates in periodic reviews of the scope of work, vendor performance, and issue resolution. • Demonstrate oversight of CROs and work in a quality framework that supports confirmatory trials. • Provide direction and leadership in CRO and vendor selection and management. • Knowledge of regulatory start up process and planning in support of study start -p • Managing and maintaining high performing clinical teams.

• Was responsible for planning, scheduling, and implementing the clinical aspects of projects in line with contract and budget, e.g., implementation of protocol and amendments; protocol deviation prevention, tracking, and reporting; IP management. • Interfaced with client and program/project staff; ensured the provision of meeting agendas and summary documentation and /or detailed information as required for internal and client meetings. • Lead clinical team meetings and prepare sections for monthly, quarterly, and annual reports; and, present at internal meetings. • Ensure successful site startup, maintenance, and close-out. • Successfully deliver operational activities, such as study start-up, site management, clinical monitoring, and data management activities. • Oversight of the management of sites to ensure compliance with the protocol, ICH-GCP, other relevant guidelines, and applicable regulations, as well as SOPs. • Deliver the project/program according to the quality management plan. Guide CRAs and advise on critical specific study issues. • Drive high performance and efficiency of the clinical team through CRA project objectives and the conduct of monitoring visits. Provide performance feedback to management on clinical team members. • Ensure appropriate subject recruitment plans are in place; all outreach or digital offerings are explored and deployed in consultation with the customer. • Provide ongoing training and support to the clinical team. Conduct frequent team meetings and ensure regular communication. • Ensure the Site Recruitment Action Plan (SRAP), patient recruitment target and contingency plans are in place and deployed at trigger points. • Deliver the project/program according to the quality management plan. Guide CRAs and advise on critical specific study issues.

• Effectively monitored study sites using risk-based monitoring approach and applied root cause analysis (RCA), critical thinking, and problem-solving skills to identify protocol deviations trends. • Identified and documented protocol deviations, trends, and study-related issues and followed up with sites for prompt resolution. Escalated issues to the clinical trial manager promptly as required. • Performed source data review (SDR) and source data verification (SDV) and ensured the study data complied with the ALCOAC+ principles and were consistent with the subjects’ clinical records in the EMR. • Performed routine site visits including PSSV, SIV, IMV, and COV, and ensured sites complied with the study protocol, Good Clinical Practices (GCPs), and applicable regulatory guidelines. • Performed investigational product accountability at the site and subject level and ensured IP were dispensed and stored according to the protocol requirements. • Effectively communicated with the PI, study coordinator, other site staff, CTM, and cross functional project team members on issues or findings and followed up to resolution. • Established and maintained excellent working relationships with PI and site staff and ensured protocol compliance and responsiveness. • Thoroughly reviewed essential documents in the investigators’ site binder (ISF) for completeness and accuracy in view of study close-out, audit, and inspection readiness. • Proactively scheduled routine on-site visits to meet the sponsor’s days on-site (DOS) expectation. • Tracked and updated DOS visits and escalated to CTM any issue as required. • Wrote detailed expense reports and submitted to the CTM within the required timeline. • Contributed to the project team by assisting other team members and working on other project work and initiatives for process improvement, as required.

• Coordinated collection of site regulatory documents on an ongoing basis for investigational sites. • Distributed and tracked protocol amendments and IRB/ethics approvals of the amendments, as required. • Sent regulatory packets to selected sites and documents/follows-up with sites on the startup process. Collaborated and liaised with interdepartmental team members (regulatory, contacts, clinical) to enable a rapid clinical trial start-up.