I am a proactive executive with a growth-mindset and subject matter expert in clinical operations, clinical compliance, risk-based quality management, analytical risk-based monitoring, CRO oversight, vendor governance, continuous process improvement, onboarding, and training. My experience spans all study phases from protocol elements document through to final database lock and CSR.✅ MY BACKGROUND IN CLINICAL OPERATIONS AND RISK-BASED MONITORING● Helped to lead the Clinical Center of Excellence in clinical compliance and risk-based monitoring.● Recognized for implementing innovative analytical risk-based monitoring strategy.● Spearheaded risk-based monitoring for a current total of 45+ global clinical trials.● Certified in risk management/risk-based quality management for clinical trials.✅ PERFORMANCE RECOGNITIONHonored with numerous awards for outstanding performance in the following areas: Risk-Based Monitoring, CRO Management, Quality, Ownership, and Teamwork.✅ THERAPEUTIC AREASCell & Gene Therapy ● Dermatology ● Gastrointestinal ● Genitourinary ● Hematology ● Immunology ● Immuno-Oncology ● Nephrology ● Neurology ● Oncology ● Rare Disease✅ DISCstyles LEADERSHIP ASSESSMENTPersuasive lead by example people manager with high standards for self and team. Objectively assess systems, procedures, and organizational operations. Present data-driven, supportable business cases to enhance operational performance.✅ NATURAL TRAITSLogical ● Analytical ● Precise ● Curious ● Positive ● Fearless ● Methodical ● Team Player✅ CLINICAL AND LEADERSHIP STRENGTHS● Clinical Development, Clinical Operations, Clinical Research,● Clinical Monitoring, CRO Oversight, Vendor Governance● Analytical Risk-Based Monitoring (ARBM), Risk-based Quality Management (RBQM)● Quality by Design (QbD), Quality Tolerance Limits (QTLs), Targeted Source Data Verification (tSDV)● Clinical Compliance, Corrective and Preventative Action (CAPA), eQMS Implementation● Electronic Trial Master File (eTMF), Document Management, User Access● Strategic Planning, Problem Solving, Critical Thinking, Relationship Building● Cross-functional Team Leadership, Communication, Coaching, and Mentoring ✅ CLINICAL PLATFORMS● RBQM → CluePoints, Infosario, MyTrials, Salesforce, Spotfire, Tableau, Veeva ● CTMS → Siebel Clinical, IMPACT Harmony, Veeva CTMS, iMedidata mCTMS, Preclarus● eDC → iMediData RAVE, Veeva CDMS● TMF → Veeva eTMF𝐓𝐞𝐫𝐞𝐬𝐚 𝐃𝐚𝐯𝐢𝐬TeresaSueDavis08@Gmail.com