Chad Scribner, Mscr, Mba, Acrp-Cp Email & Phone Number

Detroit, MI, US

• Global Phase 0, I; Gene therapy, rare-disease, cardiovascular; start-up, enrollment, maintenance, close-out
• Control overall TMF strategy development and risk-based management of all TMF operations for inspection readiness
• Develop company TMF management plans, index, SOPs, work instructions, forms, and training materials
• Oversee Veeva Vault account and approve PO, SOW/MSA, and annual renewals
• Collaborate with Veeva managed services for process improvement initiatives for Veeva Vault Clinical
• Lead internal audits, regulatory inspections, periodic reviews, start-up, close-out, and archival of Veeva Vault TMFs

Collaborate with TMF industry leaders for the creation of an industry standard TMF risk-based training program

Responsible for oversight of taxes, chapter revenue, income statements, purchases, and bank account maintenance

• Global Phase II, III, IV; Ultra-rare disease, pediatric, endocrinology, neurology; start-up, enrollment, maintenance, close-out
• Lead internal audits, regulatory inspections, periodic quality reviews, and close-out of Veeva Vault TMFs for inspection readiness
• Manage and update TMF plan and expected document lists (EDLs) for study team members
• Analyze Veeva Vault reports and TMF metrics to identify missing documentation to increase TMF completeness
• Development of TMF management tools and training of junior project specialists and clinical trial associates

United States

• Global Phase II, III, IV; Ultra-rare disease, pediatric, endocrinology, neurology; start-up, enrollment, maintenance, close-out
• Coordinated successful PMDA and MHRA regulatory inspections for drug product market approval
• Lead Veeva Vault TMF activities involving QC of documents and applying ALCOA+ principles for quality and compliance
• Executed and maintained reports (enrollment, training completion, monitoring visits, etc.) using Veeva Vault and Medidata CTMS

• Phase II-III; Infectious disease, gastroenterology, dermatology; start-up, enrollment
• Identified, selected, initiated, and closed-out investigational sites with approximately 10.5 DOS per month
• Monitored sites to ensure appropriate adherence to the study protocol, applicable federal regulations, and ICH-GCP
• Completed 146 site contacts per month with a goal of 60 for missing documentation, data entry queries, and action item resolution

Rochester, Michigan

• Wrote unexpected production deviations using root cause analysis (RCA) and developed effective CAPAs
• Managed and performed quarterly internal self-audits as lead auditor to assess compliance with regulations and SOPs

Rochester, Michigan

• Created new or modified existing SOPs to ensure compliance with new company or regulatory standards
• Conducted monthly internal audits of site to assess compliance status with 21 CFR Parts 210 & 211 and cGMP

Rochester, Michigan, United States

Rochester, Michigan, United States

Rochester, Michigan, United States

Rochester, Michigan, United States

Royal Oak Research Institute Biobank

• Experienced in fundamentals of clinical research and protection of rights, safety, and well-being of subjects
• Organized, filed, and submitted up to 30 human research samples per shift into BTM software database

Troy, MI

Master Of Science - Ms, Clinical Research, 3.94

Master Of Business Administration - Mba, 3.91

Bachelor Of Science - Bs, Biochemistry, 3.83

Activities and Societies: Treasurer of Alpha Lambda Delta National Honor Society of Oakland University Treasurer of Pre-Professional.