Tamika Thomas

• Provide territory-level leadership across high-profile Oncology and Cardiometabolic programs, supporting up to 45 clinical sites nationwide while collaborating with cross-functional teams to achieve operational and performance targets. • Directed operational oversight of up to 45 clinical trial sites, ensuring alignment with strategic objectives and delivery milestones. • Partnered closely with CRAs, Trial Managers, vendors, and executive stakeholders to resolve site challenges and optimize performance. • Strengthened sponsor presence across assigned territories by improving site engagement, communication cadence, and accountability. • Identified operational risks and implemented proactive mitigation strategies to accelerate timelines and protect study outcomes. • Delivered cost savings exceeding $50,000 through strategic close-out planning and vendor oversight • Maintained accurate opportunity and site performance tracking within CTMS systems, ensuring data integrity and visibility. • Facilitated executive-level meetings and regional communications to align stakeholders and drive results • Supported onboarding and training of site staff, increasing protocol adoption and operational efficiency.

• Progressively advanced through senior-level roles leading clinical site activation, oversight, and performance management across Phase I–IV programs. • Oversaw up to 80 clinical sites across U.S. and global territories, managing study start-up through close-out. • Activated 20 clinical sites within six weeks for a Phase IIIb cardiovascular program, resulting in over $1M in cost savings. • Managed cross-functional teams of 2–12 in-house CRAs, improving operational timelines and quality metrics. • Led inspection readiness initiatives, supporting successful audits with FDA and global regulatory agencies. • Negotiated investigator grants, vendor contracts, and operational budgets across multiple therapeutic areas. • Coordinated sample collection, device oversight, and site activation for oncology and diagnostic-focused studies. • Ensured high levels of customer satisfaction through proactive issue resolution and consistent site engagement.

• Served as Study Lead for two U.S.-based oncology clinical programs (Glioblastoma CAR-T and Solid Tumor/Melanoma), partnering with sponsors, investigative sites, and cross-functional teams to drive operational execution across the full trial lifecycle. • Collaborated closely with investigators, pathology-related site teams, and laboratory vendors to support sample handling, protocol adherence, and data integrity. • Served as primary sponsor liaison, facilitating strategy discussions, performance reviews, and milestone tracking to ensure alignment with program goals. • Directed start-up strategy, regulatory submissions, and site activation efforts to accelerate enrollment timelines. • Managed third-party vendors and CRO deliverables, ensuring contractual compliance, quality standards, and operational excellence. • Oversaw EDC build and system optimization, improving workflow efficiency and visibility across stakeholders. • Identified and mitigated operational risks proactively, protecting study timelines and maintaining regulatory compliance (ICH-GCP/FDA). • Conducted co-monitoring visits and reviewed site documentation to ensure inspection readiness and consistent quality outcomes. • Managed study scope, budgets, and forecasting, driving accountability and measurable performance improvements.

Lung Cancer PRITT (USA sites) and Prostate Cancer PSMA-R2 (USA/Global sites) • Managed study early Phase I-II start-up, late Phase IIIb maintenance, and close-out phases, ensuring strict adherence to timelines, budgets, and operational procedures • Managed with Director site oversight and close-out activities (study team and CRO) • Ensured compliance with ISO 14155, GCP, and GDPR, and corporate quality standards throughout all phases of research projects • Contributed to development of eCRFs, edit checks, eCRF completion guidelines, data review plans, and trial statistical analysis plans • Defined clinical outsourcing specifications, managed vendor interfaces, and upheld quality standards and contract compliance • Implemented study start-up and close-out activities, including eCRF validation, SAE management, and clinical trial site documentation

Prostate Cancer and Cardiovascular (Free and Total PSA and NT-proBNP for USA sites) • Supervised a team of three in-house Clinical Research Associates (CRAs), providing leadership and guidance for efficient study execution and compliance with regulatory requirements • Directed activation and operational oversight of sample collection and testing sites throughout study start-up and maintenance phases • Managed and conducted co-monitoring Site Initiation Visits (SIVs) and Interim Monitoring Visits (IMVs) • Conducted and documented site monitoring visits per study protocols, identifying issues and facilitating timely resolutions • Led active subject enrollment as primary contact, providing regular updates to senior management on recruitment progress and challenges

Early Phase I-II Oncology (Melanoma, Head & Neck, Advanced Thoracic Malignancies - Global & USA sites), Hematology close-out (USA only) • Managed early Phase I-II clinical trials across Global and USA sites, ensuring prompt site activation, enrollment, and adherence to study protocols • Conducted feasibility assessments and site selection, reviewed site usability databases, and administered versioning of study reference materials • Evaluated Monitoring Visit Reports (MVRs), formulated queries for resolution, and escalated issues or delays to clinical study trial leader and CRO • Supervised Third-Party Vendors (TPVs), tracked and processed Investigational Products (IP), and managed study close-out activities

Late Phase IIIb-IV Oncology (PV, MF, Advanced Solid Tumor, RESIST, GvHD - Global sites) • Managed global escalation processes within Oncology across four indications, ensuring efficient IP drug supply management • Formulated clinical outsourcing specifications for Contract Research Organizations (CROs), ensuring compliance with scope, timelines, and budget • Managed inspection readiness with QA and FDA • Maintained Trial Master File (TMF) regulatory documents for initiation and ongoing compliance

• Supervised over 80 clinical sites as an in-house Clinical Research Associate, imparting expertise from study start-up through close-out and mentoring counterparts to streamline timelines • Led teams of 2-12 In-house CRAs in the Lead In-house CRA role, orchestrating 3-5 SSU studies annually for optimal performance and efficiency • Guided two high-profile cardiovascular studies, ensuring Trial Master File (TMF) quality and regulatory compliance of all documents • Coordinated and prioritized a Phase IIIb study, activating 20 clinical sites within six weeks, resulting in cost savings exceeding $1 million • Implemented study start-up for 25-60 sites, overseeing clinical trial progress through regular contact with sites, Regional Site Managers, vendors, and Sanofi LSF Department • Managed budgetary matters, negotiated investigator grants, Master Contract Trial Agreements (MCTAs), and Work Orders (WOs) within assigned therapeutic areas

Phase IV Infectious Disease protocols (Pre-Treated Hepatitis C & Naïve Hepatitis C - Global and USA Sites) • Supervised 15 regional monitors for a global study, reviewing Monitoring Visit Reports and resolving 1,500 dosing queries over six months • Managed and conducted co-monitoring Site Initiation Visits (SIVs) and Interim Monitoring Visits (IMVs) • Resolved 800 queries and cleaned patient profiles and cohort data within three months for a Phase IV study • Oversaw 5 Sr. CTAs in resolving approximately 1,500 dosing device discrepancies and performed bi-monthly review and QC of Patient Profiles

Phase IV CNS protocols (Alzheimer's Disease & Schizophrenia - Global and USA sites) • Monitored study data, identifying and providing feedback to Directors to promptly resolve issues and ensure data integrity • Liaised with 10 CRAs for domestic USA sites, ensuring efficient query resolution and smooth study closure processes • Administered maintenance and forecasting of study budget, coordinating and negotiating vendor contracts • Evaluated ICF reviews and submissions to IRBs, reviewed and submitted Investigator Initiated Package (IIP) regulatory documents