Angie McKellar

About Angie McKellar

I am a seasoned Clinical Data Management and Program Management professional with 20+…

Experience

1. Senior Clinical Data Management Consultant

   Precision For Medicine

   May 2025 — Present

   Senior level consultant providing strategic oversight of global CDM programs, including 250+ clinical trials (Phase I–IV, interventional and observational).• Advises sponsors and CROs on regulatory compliance (ICH-GCP, CDISC, FDA, EMA), supporting audits, inspections, and corrective/preventive action (CAPA) plans.• Recruits best in class / best-fit candidates for cross functional roles.• Delivers process harmonization strategies, aligning SOPs and data workflows across global sites / departments.• Supports business development through bid defenses, proposal evaluations, etc.• Provides therapeutic expertise in multiples areas including but not limited to oncology, neurology, rare disease, infectious disease, and metabolic/endocrine disorders.• Leads vendor oversight, including EDC providers and CROs, ensuring seamless data transfer, integration, and reporting.• Mentors and develops junior staff, building high-performing CDM teams across North America, Europe, and APAC.• Designs and implements process improvements including improved database lock timelines and reduced operational costs.• Directs database design, edit check programming, validation, data review, and lock activities, ensuring high-quality and inspection-ready deliverables.

Education

• East Carolina University

  NA

• East Bladen High School, Elizabethtown, NC

  High School Diploma