Rosa Izquierdo

Background

About Rosa Izquierdo

As a Clinical Team Manager am accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the Customer. Manages all clinical operations aspects of allocated studies. Serves as the primary clinical operations contact for the Project Manager. Responsible for the co-ordination and management of all clinical operations project team members on an international basis (particularly CRA’s), within designated projects. Implements and manages the necessary training, tracking and quality systems within the clinical portion of the project. Involved in regular and proactive liaison with the Project Manager, Clinical Operations Managers and other functional groups as appropriate. Co-ordinates standardised start-up and clinical monitoring guidelines (in conjunction with query guidelines). Ensures essential document quality. Reviews monitoring visit reports. Performs co-monitoring visits where necessary. Identifies and performs any required trouble shooting activities. Manages query resolution process. Regulatory Compliance Reviewer: Performing a final and independent quality control of essential documents required for start of a clinical trial in Europe/Africa/Australia. Specialties: Infections/Parasitic Disease: HIV, Respiratory Syncytial Virus (RSV) Oncology: Leukaemia, Head and Neck cancer Endocrine –Metabolic: Diabetes Mellitus Haematology: Coagulation defects- Haemophilia Mental Disorders: Major Depression Circulatory-Hypertensive Disease