Jolee Miller

About Jolee Miller

Highlights• Over 15 years in Clinical Research Industry• Contributed to over 20 studies in various sizes and complexity- up to 20 countries, patients, and $23 million in budget• Over 5 years of managing studies as a project manager• Over 12 years practicing and perfecting project management skills• Professionally trained in PMBOK principles and in training for PMP certification • Managed: o Fully outsourced studies from CRO side and partially outsourced from Sponsor side o Phase I, II, and IV global studies o Each project phase from Study Phase Design to Study Close Out• Experienced with o IRT, CTMS, EDC, eTMF, eConsent, EMR integration, digital recruitment platforms, PRO, patient video recording apps o MS applications, Smartsheet, MS Project, PeopleSoft and Oracle systems used for purchase orders, invoicing and payment approvals o Full scope of Project Management responsibilities and activities • Adherence to FDA and ICH Good Clinical Practice with re-certification annually• Over 2 years as Ophthalmic Tech in large vision clinic• Over 3 years in QA and local RA (Food Industry)THERAPEUTIC AREAS• CNS: Tardive Dyskinesia- 0.5 years• Gene Therapy: Hemophilia, neovascular Age-Related Macular Degeneration – 2.5 years• Hematology: Hemophilia- 1.5 years• Infectious Disease: Influenza- 5 years• Oncology: Metastatic Cancer, Non-Small Cell Lung Cancer- 3 years• Ophthalmology: Adenoviral Conjunctivitis, Bacterial Conjunctivitis, neovascular Age-Related Macular Degeneration, Diabetic Retinopathy/ DME- 5 years• Rare Disease: Cystic Fibrosis, Amyloidosis – 3.5 years• Rheumatology: Rheumatoid Arthritis, Lupus Erythematosus, Gout- 6 years• Respiratory: Asthma, Cystic Fibrosis, Fungal Respiratory Infection- 6 years

Experience

1. Clinical Project Manager

   REGENXBIO

   Nov 2021 — Present

   Develops and maintains the clinical trial deliverables including timelines, budget, and resource requirements.• Provides matrix management of cross functional representatives to manage clinical execution deliverables • Reviews and refines clinical operations plans for each study• Develops and constructs content for risk mitigation plans related to the study to ensure clinical trials are on time and within budget• Implements clinical trial ensuring that clinical trials are conducted in a timely fashion and compliant with SOPs, GCP, and regulatory guidelines, company goals, and budgets• Partners with clinical development and cross functions to draft the Clinical Protocols, Investigator’s Brochures (IBs), Case Report Forms (CRFs), Informed Consent Forms (ICFs), and Clinical Study Reports (CSRs), and manages timelines for the completion of these documents• Lead selection process for outsourced activities• Leads the selection of specialty vendors including development of scope of services agreements, budgets, and plan and timelines• Manages CRO/vendor agreements, ensuring that change orders and budgets meet clinical operations specifications• Reviews invoices for accuracy compared to operational plans, budgets, and work known to be performed by CRO/vendors• Lead ongoing review of data to ensure quality and consistency through study execution• Manages CRO/vendors to achieve goals and ensures that performance expectations are met• Responsible for working with the CRO to plan everything from early engagement for protocol feedback to database lock• Participates in patient identification activities and the development of patient recruitment plans and back-up plans• Identifies, recruits, and approves clinical investigators in collaboration with Medical Monitor and Clinical Operations leadership

Education

• William Jewell College

  Bachelor of Arts (B.A.), Biology, General

Skills

• Edc
• Ctms
• Ich-Gcp
• Infectious Diseases
• CRO
• Gcp
• Regulatory Submissions
• Clinical Data Management
• Clinical Monitoring
• Project Management
• Public Health
• Clinical Research
• Clinical Trials
• Ophthalmology