Director, Global Clinical Operations Monitoring Oversight, Therapeutics And Oncology
Current
Jul 2024 - Present
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Teresa Davis Email & Phone Number
Director, Global Clinical Operations Monitoring Oversight, Therapeutics and Oncology
at
Moderna
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Role
Director, Global Clinical Operations Monitoring Oversight, Therapeutics and Oncology
Location
Durham, North Carolina, United States
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Teresa Davis is listed as Director, Global Clinical Operations Monitoring Oversight, Therapeutics and Oncology at Moderna, based in Durham, North Carolina, United States. AeroLeads shows a matched LinkedIn profile for Teresa Davis.
Teresa Davis previously worked as Associate Director, Clinical Operations Compliance | Process & Training at Kite Pharma and Director, Operational Process - Clinical Operations at Replimune. Teresa Davis holds Bachelor Of Art, English - World Literature from North Carolina State University.
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Moderna
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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● 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
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13 roles
Teresa Davis work experience
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Associate Director, Clinical Operations Compliance | Process & Training
Contracted to develop, optimize, align, and implement shared clinical trial processes through creation and deployment of process improvements, training curricula, training compliance metrics, and reporting. Lead two Kite RBQM workstreams as a Kite RBQM Change Champion. Increase clinical compliance awareness, improve compliance metrics and promote a culture of compliance. Support internal CAPA implementation.
Jan 2024 - Jun 2024
Director, Operational Process - Clinical Operations
I led the company’s largest team with 3 divisions and 2 inspection readiness workstreams and am the SME for cross-functional process improvements in clinical operations, clinical compliance, and clinical supply.The clinical portfolio encompassed CRO management of 8 clinical trials and 279 sites.✅ ACTIONABLE ACHIEVEMENTS➞ Rolled out automation of the electronic Trial Master File (eTMF) framework.➞ Managed all portfolio-level corrective and preventative actions (CAPAs) across 5 active studies.➞ Maintained all Clinical Operations SOPs, updates, and periodic reviews.➞ Strengthened CRO oversight and partnership.➞ Expanded the TMF operations team.
Apr 2022 - Jan 2024
Associate Director, Clinical Compliance – Clinical Operations
I was hired into a newly created role to support clinical compliance, vendor governance, to collaborate cross-functionally with QA and clinical operations, to boost SOP compliance, and ready for registrational application filing.My knowledge of electronic systems, clinical compliance, clinical operational process, drug development, and risk-based monitoring were key factors in selecting me for the one-of-a-kind position.✅ ACTIONABLE ACHIEVEMENTS➞ Implemented an electronic quality management system (eQMS).➞ Created consistent framework across all joint operating committees (JOCs) within vendor governance.➞ Supported the implementation of commercial drug releases across Nektar.
Oct 2021 - Apr 2022
Manager, Clinical Center Of Excellence – Clinical Compliance And Risk-Based Monitoring
Astellas Pharma Us
I helped to lead a new Center of Excellence created to implement risk-based quality management strategies across all clinical trials and migrate legacy studies to the electronic RBQM system (CluePoints).✅ ACTIONABLE ACHIEVEMENT➞ Steered clinical teams through risk assessment and categorization tool (RACT) process for 7 clinical trials.➞SME for analytical risk-based monitoring.
May 2021 - Oct 2021
Manager, Risk Management Central Monitoring
I acted as a SME for the Analytical Risk-Based Monitoring (ARBM) Department within the immunology therapeutic area, and piloted the Central Statistical Surveillance (CSS) program for assigned clinical trials.✅ ACTIONABLE ACHIEVEMENTS➞ Presented with a leadership award for ARBM outsourcing.➞ Supported as a SME for targeted Source Data Verification (tSDV) implementation.➞ Continuously improved ARBM activities and central monitoring processes.
Sep 2019 - May 2021
Senior Specialist, Central Monitoring Manager
Jan 2017 - Sep 2019
Clinical Monitoring Associate Ii – Global Monitoring Operations
I performed remote site monitoring, reviewed all site data for accuracy and alignment to study plans, ensured eTMF was always inspection ready, mentored junior staff, and exceeded all performance goals.✅ INTERNAL RECOGNITION➞ Nominated by colleagues and managers for a total of 18 awards.
May 2015 - Jan 2017
Lead Icra ➞ Cra Ii, Clinical Site Monitoring - Clinical Operations
I conducted onsite/remote clinical monitoring, onboarded and trained iCRAs/CRAs, created patient recruitment plans and materials, and managed the patient transfer process for 3 global clinical trials.✅ ACTIONABLE ACHIEVEMENTS➞ Received 4 internal awards for teamwork, quality, and leadership.
Jan 2013 - May 2015
In-House Clinical Research Associate 2
Dec 2011 - Jan 2013
Global Clinical Trials Assistant
Sep 2011 - Dec 2011
Prevention Research Specialist ➞ Hiv Prevention Trials Network
Jul 2010 - Sep 2011
Clinical Research Associate
Nov 2009 - Jul 2010
2 education records
Teresa Davis education
Bachelor Of Art, English - World Literature
North Carolina State University
Fine/Studio Arts, General
Mississippi State University
FAQ
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What company does Teresa Davis work for?
Teresa Davis works for Moderna.
What is Teresa Davis's role at Moderna?
Teresa Davis is listed as Director, Global Clinical Operations Monitoring Oversight, Therapeutics and Oncology at Moderna.
Where is Teresa Davis based?
Teresa Davis is based in Durham, North Carolina, United States while working with Moderna.
What companies has Teresa Davis worked for?
Teresa Davis has worked for Moderna, Kite Pharma, Replimune, Nektar Therapeutics, and Astellas Pharma Us.
How can I contact Teresa Davis?
You can use AeroLeads to view verified contact signals for Teresa Davis at Moderna, including work email, phone, and LinkedIn data when available.
What schools did Teresa Davis attend?
Teresa Davis holds Bachelor Of Art, English - World Literature from North Carolina State University.
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