プロフィール詳細

プロジェクトを作成

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Diana T.に依頼

Romania

Clinical Research Development Associate/ Freelancer

プロフィール概要

A background of almost 17 years experience in managing and monitoring Clinical Trials, multinational studies (phase II, III and IV ) with study expertise experience. Have been monitoring a number of around 40 multinational trials; responsibilities have spanned the full duration of studies, from start-up to project close-out and review, project management and consultancy. Clinical Research Consulting services (project management, education & training, provider of clinical trial tools for site's staff) - with a significant clinical trial management experience gained as a SrCRA/ LeadCRA/ Associate to Project Management responsibilities; - certified Clinical Research Associate, Clinical Research Monitoring & Coordination - experience managing global projects and delivering/covering country specific outcomes; ability to work and interact in a multicultural environment at global and country levels; ability to work and interact with global and country vendors; - strong knowledge of ICH-GCP; - effective experience of the regulatory submissions and start-up activities - feasibility process coordination in Romania - great negotiation skills with clinical contracts - strong customer focus; effective interpersonal skills, strong attention to details; - trial management leadership and experience, ability to prioritize, work and deliver under the pressure of very tight timeliness. Experience Summary: Coordination of project team Feasibilities and Start –up Activities Submission to Local Authorities( RA, CEC, LEC) Site Selection Visits , Initiation Visits Monitoring Visits and SDVs Closure Visits Archiving Query Resolution Management Management of SAE reporting Drug Accountability Delivery of GCP Training to the staff Participation in site Audits Study Files Preparation Essential Documents Collection and QC Review of Regulatory Documentation eTMF review and QC Submission File Preparation Insurance Activities ICF Customization Labels Customization Re-labeling Procedures Remote Monitoring Reports Review Attending to IM Contract Customization and Negotiation Design of Patient Recruitment and monitoring tools Monitoring Plans Development Therapeutic experience: Psychiatry- Schizophrenia, Alzheimer’s Disease and Tourette Syndrome Endocrinology – Acromegaly Gastroenterology –Crohn Disease Oncology- Breast, Prostate, Solid Tumors and Colorectal Cancer Oncology- HCC in hepatitis C virus(HCV) infected Oncology- HSIL Dermatology- Chronic Plaque Psoriasis, Alopecia Areata, Facial Wrinkles Cardiology-Acute Heart Failure( Iron Deficiency) Cardiology- Coronary artery disease-Myocardial Infarction Pulmonary-Asthma Neurology –Epilepsy Nutrition – Type 2 Diabetes Renal-anemia in chronic non dyalisis dependent kidney disease Renal- Lupus Nephritis Orthopedic- Osteoarthritis of the knee Infectious Diseases-COVID-19

専門分野

• ★ Clinical Trials
• ☆ Biophysics
• ☆ Pharmaceutical Manufacturing
• ☆ Pharmaceutical Process Development
• ☆ IRB Applications
• ☆ Patient Recruitment
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Dermatology
• ☆ Skin Cancer
• ☆ Neurology
• ☆ Pediatric Neurology
• ☆ Epilepsy & Seizures
• ☆ Clinical Neurophysiology
• ☆ Neuromuscular Disease
• ☆ Movement Disorders
• ☆ Non-Alzheimer's Dementia
• ☆ Parkinson's Disease
• ☆ Alzheimer's Disease
• ☆ Headache & Migraine
• ☆ Multiple Sclerosis
• ☆ Neuroendocrinology
• ☆ Stroke & Cerebrovascular Disease
• ☆ Women's Health
• ☆ Breast Cancer
• ☆ Men's Health
• ☆ Prostate Cancer
• ☆ Gastroenterology & Hepatology
• ☆ Colorectal Cancer
• ☆ Crohn's Disease
• ☆ Endocrinology
• ☆ Clinical Laboratory Science
• ☆ Clinical Pathology
• ☆ Metabolism & Metabolic Disease
• ☆ Sclerosis & Demyelinating Diseases
• ☆ Supply Chain & Logistics
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Research Methodology
• ☆ Feasibility Studies
• ☆ Presentation Design
• ☆ Instructional Webinars
• ☆ Medical Writing
• ☆ Patient Education Materials
• ☆ Technical & Scientific Writing
• ☆ Instructional Materials
• ☆ Literature Review
• ☆ Systematic Literature Review

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, General Proofreading & Editing

Research Feasibility Study, Systematic Literature Review

Consulting Business Strategy Consulting, Healthcare Consulting, Operations Consulting, Financial Consulting

Data & AI Data Cleaning

Product Development Recipe Development

職務経験

Clinical Research Development Associate

Freelancer

9月 2017 - 現在

学歴

Medical Physicist

University of Bucharest, Biophysics Dpt.

10月 2000 - 6月 2004

認定資格

• 認定資格の詳細は未入力です。