Ophélie Orset

Clinical Project Manager

Research engineer trained in Clinical Project Management with more than 13 years of experience in Clinical research in various settings, from Pharma to CRO, and in both drug development and medical devices. Her experiences include 7 years as a clinical research associate, over three years as a clinical project coordinator, and three years as a clinical project manager. Ophelie’s responsibilities include

Management of clinical studies from inception to set-up, to execution and close out
Quality Management
Oversight of monitoring activities

Experience

Immunotherapy Phase III in Hepato-carcinoma; Metastatic or unresectable melanoma; Non-small cell lung cancer; Cutaneous Squamous Cell carcinoma; Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Chemotherapy Phase III in Non-Small-Cell Lung Cancer
Small molecule Phase III in Haematology Cytomegalovirus
vaccine Phase III in HIV infection
Small molecules Phase II/III in Bacterial Infections in pediatric populations
Chemotherapy Phase II in Advanced or Metastatic Breast cancer
Immunotherapy Phase II in Selected solid tumors; Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer
Small molecules Phase II in Pulmonary; Respiratory Metabolism & endocrinology Orthopedics Idiopathic Pulmonary Fibrosis; COPD
Medical device Phase II in Acute Hepatic Porphyria; synthetic RNA interference (observational natural history); Tyrosinemia / Inhibitors (Phase I/II) Scoliosis and spine surgery, Medical devices (Phase III and post-market) Orthopedics / Medical devices (post-market)