Clinical Team Manager / Senior Clinical Team Manager
Since June 2012
as a senior Clinical team manager at ppd, has successfully conducted a number of full service Clinical studies in accordance with ich-gcp and the appropriate standard operating procedures. has gained experience in: • Phase I studies • Phase II studies • Phase III studies • excellent knowledge of the Pharmaceutical Industry, CRO, and at study site • leading and managing international, multi-cultural project teams. • developing Clinical tools and processes for the study team to support the execution of Clinical deliverable and study timelines • manage Clinical study set-up and follow-up study activities • collaborate with Data Management, Pharmacovigilance, and Biostatistics to support milestone achievement. • ensure high performance and efficiency of the Clinical team • develop the Risk Management plan from a Clinical perspective and coordinate Clinical issue escalation and resolution. • identify quality issues and implement appropriate corrective action plans. • track Clinical budget consumption • has obtained a wide experience of studies in numerous indications including: dvt, pulmonary embolism, invasive fungal disease, chronic lymphocytic leukaemia (b-cll), colon Cancer, mantle Cell non-hodgkin's lymphoma, non-small Cell lung Cancer, hepatocellular carcinoma, breast Cancer, human immunodeficiency Virus and glabella wrinkles. As a Senior Clinical Team Manager at PPD, has successfully conducted a number of full service clinical studies in accordance with ICH-GCP and the appropriate standard operating procedures. Has gained experience in: • Phase I studies • Phase II studies • Phase III studies • Excellent knowledge of the pharmaceutical industry, CRO, and at study site • Leading and managing international, multi-cultural project teams. • Developing clinical tools and processes for the study team to support the execution of clinical deliverable and study timelines • Manage clinical study set-up and follow-up study activities • Collaborate with data management, pharmacovigilance, and biostatistics to support milestone achievement. • Ensure high performance and efficiency of the clinical team • Develop the risk management plan from a clinical perspective and coordinate clinical issue escalation and resolution. • Identify quality issues and implement appropriate corrective action plans. • Track clinical budget consumption • Has obtained a wide experience of studies in numerous indications including: DVT, Pulmonary Embolism, Invasive Fungal Disease, Chronic Lymphocytic Leukaemia (B-CLL), Colon Cancer, Mantle Cell Non-Hodgkin's Lymphoma, Non-Small Cell Lung Cancer, Hepatocellular Carcinoma, Breast Cancer, Human Immunodeficiency Virus and Glabella wrinkles.
Senior CRA/LCRAJanuary 2009 --- June 2012
Senior Clinical Research AssociateJanuary 2009 --- June 2012
Clinical Research Associate (CRA)February 2007 --- November 2008
Freelance Lead Clinical Research AssociateOctober 2006 --- November 2007
lead Clinical Research Associate for a Phase II study. responsible for the co-ordination and progress of the study, including co-ordination of other parties, also responsible for drug management and accountability procedures; responsible for project related Training and managing of involved staff where necessary, participated in meetings with investigators/ Planning /demands; maintained knowledge at the area of Clinical monitoring, Quality Control, Adverse Events reporting procedures and Good Clinical Practice; monitoring activities (initiation visits, monitoring visits, close out visits) according to ICH guidelines; managed and trained project related issues where necessary all involved staff; participated in Investigator meetings.
assistentJune 1998 --- May 2004
part time work at mental Hospitals + part time work at mental house share
LinkedIn Assessment :
Bachlor in Nursing from H:S in 2001
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