Teresa Davis
Senior Director, Clinical Operational Excellence
- Role
- Senior Director, Clinical Operational Excellence at Deciphera Pharmaceuticals
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Teresa Davis
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 Co-led building and implementing a full Monitoring Oversight capability. 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, DETECT CTMS → Siebel Clinical, IMPACT Harmony, Veeva CTMS, iMedidata mCTMS, Preclarus eDC → iMediData RAVE, Veeva CDMS TMF → Veeva eTMF T••••••••@Gmail.com
Experience
Senior Director, Clinical Operational Excellence
May 2025 — Present · Durham, NC, US
Education
Mississippi State University
Fine/Studio Arts, General
North Carolina State University
Bachelor of Art, English - World Literature
2003 — 2006
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