Margarida Garcia Garcia

Project Manager at the CRO Adknoma Health Research, including the following responsibilities: -Collaboration with General Manager of the company for development of strategies to promote the company -Collaboration with customers and internal and external providers for the development of clinical trials and studies -Planning and organization of resources and tasks to be done -Management of International and National trials / studies with developers and researchers -Planning and coordinating the logistics of trials / studies, identifying risks, dependencies, efficiencies and critical path objectives -Preparation and management of meetings with researchers -Development and technical supervision of documentation including protocols, Data Case Report Forms, feasibility plans, monitoring, data management, statistical analysis and ICH and non-ICH reports -Medical writing of publications

My job as Head of Clinical Operations included the following tasks, additional to my tasks as Project Manager: -Prepare budgets of projects and maintain/improve budget limitations to meet projects objectives and standards according to sales projections. -Participate in preparing, reviewing and evaluating the project costs to ensure the company cost are efficient. -Establish production standards of efficiency, minimum wastages and maximum utilization of resources (manpower) and develop . -Supervises production processes to ensure implementation of company standards. -Establish quality control standards and procedures. Ensures strict adherence to those standards. -Prepare annual production plans and obtains approval of General Manager. -Coordinate with General Manager to: -Plan production capacities according to yearly sales projections. -Monitor workloads to review production schedule accordingly. -Apply effective modification on projects plans for timely production of special orders or promotional items. -Prepare annual manpower plan. Makes sure all vacant positions are filled in coordination with personnel manager. -Ensure proper training of personnel to upgrade their professional and maintain the equipped level of quality standards to achieve the operational goals.

My job during this period included the following responsibilities, additional to my tasks as Project Manager: -Management of workloads of department of Project Management -Management of resources of such department -Support to General Manager doing Business Development tasks I was in charge of 4-8 people.

Project Manager at the CRO Biometrica of clinical trials and clinical studies of eficcacy/efectiveness and tolerability of several drugs and diagnostic tests including the following responsibilities: -Management of clinical trials and clinical studies with sponsors and investigators -Planning and coordinating the logistics of trials / studies -Development and technical supervision of documentation including protocols, Data Case Report Forms, feasibility plans, monitoring, data management, statistical analysis and ICH and non-ICH reports -Medical writing of publications

Scholarship for the following projects of research at the Universitaire Institute of Public Health of Catalonia: -Evaluation of the validity, reliability and sensitivity to change of quality of life questionnaires MOS-HIV and HIV-MQOL in HIV-infected patients, funded by Merck Sharp & Dohme -Validation of the Spanish version of Liebowitz Social Anxiety Scale, Social Anxiety and Distress Scale and Sheehan Disability Inventory questionnaires for assessment of social phobia, funded by SmithKline Beecham -Dermatology Life Quality" funded by Novag / International Ferrer My participation in these projects included the following responsibilities: -Development of protocols and data collection notebooks -Presenting doctors studies researchers -Monitoring -Statistical analysis of data -Development/medical writing of final reports and publications