Tyler Miller

About Tyler Miller

A strategic and results-driven Project Manager seeking a strong collaborative and growth-oriented organization within the Clinical Research Industry. My proficiency includes all-inclusive management of clinical research trials (bid-defense through TMF delivery), adherence to regulatory standards, risk mitigation oversight, and leading cross-functional teams to ensure delivery of studies that adhere to approved scope while aiming for the highest quality benchmarks possible.My preference is dynamic, collaborative settings where my managerial expertise can be applied to ensure seamless coordination/communication between sponsors, CROs, vendors, leadership, and internal teams. Perceptive to process innovation and optimization, enhancing the operational efficiency while maintaining strict adherence to ICH-GCP and FDA/EMA regulations. Open to in-office, hybrid, or remote work, though hybrid and remote work is preferred.

Experience

1. Research Clinical Study Specialist Ii

   RTI International

   Sep 2025 — Present · Durham, NC, US

   Independently manages and provides guidance and oversight for all components of clinical trials, from protocol/manual of procedures development and investigational new drug (IND) application submission, through to CSR and publication.• Proactively manages and leads a cross-functional study team, including risk identification and mitigation planning.• Recommends and implements innovative processes to improve and positively impact clinical trial management and deliverables.• Performs site and study management and collaborates with data managers, statisticians, regulatory experts, pharmacovigilance team, site monitors, etc.• Acts as a cross functional liaison, communicating trial status and issues, to ensure trial plan aligns with program and client goals.• Responsible for creating and maintaining timelines, including aligning study start-up, enrollment projections, study conduct, and close-out activities with study and project goals, and using these timelines to track and manage trial progress.• Responsible for managing trial and vendor budgets, including review of invoices for accuracy.• Manages clinical site budgets and contracts for assigned clinical trials.• Responsible for oversight of site monitoring activities.• Works closely with the study team to develop trial associated clinical forms/data collection tools, including electronic CRFs and user acceptance testing, SAE forms, etc.• Oversees the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participates in data reviews.• Responsible for the development of study plans, manuals and study specific documentation including informed consent forms.• Assist in the preparation of study protocol(s), informed consent documents, clinical study reports, clinical sections of IND applications, IND annual reports, etc.• Responsible for oversight of study Trial Master File (TMF) for inspection readiness.

Education

• Appalachian State University

  B.S. Degree, Biology Pre-Professional

  2006 — 2010

Skills

• Pharmaceutical Industry
• Sop
• Microsoft Office
• Ctms
• Lifesciences
• Alzheimer's Disease
• Research
• Oncology
• Gcp
• CRO
• Teaching
• Time Management
• Clinical Trials
• Data Analysis
• Training
• Clinical Research
• Data Management