Dana Moore
Senior Director, Global Regulatory Affairs & Study Start-up @ CTI Clinical Trial and Consulting Services
About
Proactive, performance-driven global regulatory and study start up professional with 20+ years clinical research experience including 15+ years management. Experience from Phase I to IV with Industry (IND & IDE), Government & Investigator-Initiated trials across various therapeutic areas during study start-up, maintenance/recruitment, & close-out. Advanced Clinical 2024/2025 Star & REAL Awards & IQVIA Biotech 2020 Leadership Award recipient. Nominated participant in IQVIA Emerging Leadership 2022 Training Program. AREAS OF EXPERTISE *HR Management *Leadership *Strategic Planning *Metrics Development/Reporting *Cross Functional Collaboration *Mentorship *Quality Control *Resource Management *Negotiation *Site ID/Feasibility *Regulatory Documents *ICF Review *Site Contract Documents *Risk Assessments *Clinical Trial Managment Systems (CTMS) *Business Development *IT Business Design *Vendor Management (e.g., IRB, CRO)
United States
Raleigh-Durham-Chapel Hill Area
Hospital & Health Care
Study Coordination, Financial Forecasting, Coaching & Mentoring, Strategic Initiatives, Standard Operating Procedure (SOP), Auditing, Budgeting, Strategy, Business Development, Project Management, Good Clinical Practice (GCP), Supervisory Skills, Analytical Skills, Organizational Leadership, CRO, CTMS, Regulatory Documentation, Management, People Management, People Development
Experience

Senior Manager, Site Start-up (FSP)
On assignment with a global biopharmaceutical company • Accountable for the successful execution of study start-up (SSU) activities for a complex global outsourced trial with 185+ sites across 24 countries • Contribute toward expeditious site activation: >50% sites open to enrollment in 17 countries within nine months of first site activated (FSA) study milestone and of 15 countries, 100% country activations within 3 months of FSA in the country • Collaborate with the CRO partner to maintain timelines • Accountable for all matters related to CRO partners’ study start-up requirements and communicate issues effectively to CRO counterparts and Sponsor colleagues (e.g., CTM, AD/Director SSU) as required • Review program level directives, plans, and/or documents to ensure consistency across studies • Mentor/support staff on SSU tasks and serve as a backup for colleagues Therapeutics area: Oncology

Director, Site ID, Site Feasibility & North America Study Start-up
(IQVIA Biotech) • Managed department a team of 120+ (NA, LATAM, India, EU) including 4 Line Managers (NA and India) in performing site identification, site feasibility and site start-up activities; Integrated Site Service (ISS) Operational Bidders; and Resourcing Management support staff and administrators • Worked with Department Leadership Team and Senior Director ISS to continually identify leading edge initiatives that support IQVIA Biotech’s overall strategic goals, business and operational metrics and sales/profit objectives • Accountable for the deliverables, profit/loss and metrics carried out within the global department • Collaborated with Regulatory, Clinical, Project Management, Therapeutic Heads, Sales, Finance and other departments/stakeholders in implementing strategic goals for the department and company Therapeutic areas: Early & Late Phase Oncology, Pediatric, Rare Disease, Cardiology, Endocrinology, Respiratory, Hematology, CNS, Dermatology

Associate Director, North America Study Start-up
Morrisville, North Carolina
(Novella Clinical now known as IQVIA Biotech) • Managed a NA team of 50+ including up to 3 Line Managers (NA) supporting the hiring, resourcing, and executing SSU activities for over 150 projects at any given time • Accountable for NA operational SSU by supporting the sales and proposals teams to acquire new business; support operational teams to meet metrics, timelines and deliverables; serve as a point of escalation for clients and internal team and assist with problem solving

Associate Director, Investigator Strategy Site Coordination
Novella Clinical/IQVIA Biotech • Managed NA team in performing site ID, feasibility, SSU, site file maintenance and site file close-out activities for multiple studies and projects • Supervised the quality and productivity of staff based on customer service feedback, financial forecasting and billable utilization target assessments
Dana Moore's Contact Information
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