Silvana William

Background

About Silvana William

Silvana William has over 09 years’ experience in the Clinical Research Industry as a Project Manager, Clinical Operations Lead and Clinical Research Associate.Over the last 04 years, Silvana William has been working in Global Project Management for both Pharma and CRO industry working across phase I-IV of clinical research, with most recent experience in Phase IV.Major accomplishments include recently leading a critical client Study, PV and systems audit for Triple Negative Breast Cancer (TNBC study) which ended up with Zero findings.Silvana do have a strong background in clinical monitoring in all aspects of study phases from site selection to close-out and EC/CA submission in addition to monitoring investigator performance and adherence to protocols and ICH-GCP GuidelinesSilvana William holds a bachelor’s degree in Pharmaceutical Sciences and Biotechnology, German University in Cairo, Egypt and finalized the project Management Professional Preparation Exam Course at 2015.Silvana's experience includes multi-national, medium and large scale, Phase I, II, and diverse types of NIS and LICTs. Geographically, experience encompasses ASPAC and NEMEA.• 07 years in Oncology/Hematology clinical studies• 04 years in Project Management [including but not limited to project oversight/clinical monitoring/ leading clinical teams and liaising with the customer and third-party contractors to ensure that clinical start-up and monitoring tasks are conducted in accordance with protocol, processes, quality standards, regulatory requirements and expectations, per contract.• 04 years managing Global studies across NA/EU/APAC, including 02 years as a Project Manager and 02 years as a Clinical Operation LeadSpecific Oncology and Hematology experience includes: • Phase Acute Myeloid Leukemia: 1 year (1 study)o Non−Small Cell Lung Cancer (NSCLC): 5 years (2 studies)o Chronic Lymphocytic Leukemia (CLL): 5 years (2 studies)o Metastatic Colorectal Cancer: 5 years (1 study)o Urothelial or Non-Urothelial Carcinoma of the Urinary Tract: 3 years (1 study)o Follicular Non-Hodgkin’s lymphoma (NHL): 3 years (1study)o Ovarian Cancer: 3 years (1 study)o Breast Cancer: 2 years (2 studies)• Additional experience: Rheumatoid arthritis, Type 2 Diabetes Miletus (T2DM), Pulmonary Hypertension, Idiopathic pulmonary fibrosis, Amyotrophic Lateral Sclerosis, Parkinson's Disease, Sickle Cell Disease (SCD), Female infertility, Vital Thrombosis embolism (VTE) and Community Acquired Pneumonia (CAP).