Lucy Spencer
President @Insight Clinical Consulting
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WORK HISTORY
President @Insight Clinical Consulting
San Marcos, CA, US
Goal to ensure the successful set-up, maintenance, and closure of clinical databases in accordance with GCP and GCDMP. Thorough and broad knowledge of data management systems and processes, with experience in Phase I through Phase IV clinical trials.Collaborative, motivated, knowledgeable, and passionate.CERTIFICATIONS:Society of Clinical Data Management, Certified Clinical Data Manager (CCDM®)Medidata Rave® 5.6.4 Certified Study BuilderMedidata Rave® 5.6.4 Certified Study AdministratorCDMS EXPERIENCE:Medidata Rave®, Oracle InForm, DATATRAK ONE®, Medrio, iDataFax, SynCapture™, Clinical StudioSPECIALTIES:CRO oversight, process development and improvement, controlled documentation, training, EDC onboarding, GCDMP, CDASH, extensive experience with “rescue” studies, audit readinessINDICATION EXPERIENCE:Malignant Melanoma, Colorectal Cancer, Advanced Solid Tumors, Advanced Solid Tumor Malignancies, Hematologic Malignancies, Chronic Myeloid Leukemia, Lymphoid Malignancies, Multiple Myeloma, Breast Cancer, Non-Small Cell Lung Cancer, Extensive Stage Small Cell Lung Cancer, Ovarian Cancer, Bladder Cancer, High Grade Glioma, Anaplastic Gliomas, GNE myopathy, Mucopolysaccharidosis (MPS) VII, Dravet Syndrome, Lennox-Gastaut Syndrome, Hypertension, Dementia Alzheimer\'s Type, Chronic Obstructive Pulmonary Disease (COPD), Asthma, Opioid-Induced Constipation, Acute Kidney Injury, Idiopathic Pulmonary Fibrosis, Surgical Wounds, Oral Mucositis, Post-Operative Nausea and Vomiting.
EDUCATION
UC San Diego
BA Sociology
ABOUT LUCY SPENCER
Clinical Data Management professional with 20+ years’ experience - providing consulting services for small to midsize pharma clients. It is our passion and goal to provide top-notch Data Management services. We maximize our value by leveraging industry experts with 15-25 years of experience, bringing best-in-class expertise. Our deep industry knowledge, nimble and scalable design, dedicated staff, and superior service is what sets us apart.
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