Paulo Garcia

Experience

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  Joaquim Chaves Saúde

  Jan 2006 - Jan 2008

  Laboratory Technician

  A technician of Clinical Analysis and Public Health as a solid knowledge on a wide range of exact, biological, medical and social sciences, which sustain the understanding of the enormous importance of laboratory on diagnosis, prognosis, treatment, monitoring and prevention of disease, physiopathology, epidemiology, identification of statistical techniques appropriate for an accurate interpretation of results, accomplishment of research projects, knowledge of laboratory good practices and also ethical and legal issues. The professional profile is characterized by a a set of capabilities and skills which allows them to perform, develop, evaluate, correlate and ensure precision and accuracy of laboratory indicators. Show less

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  KeyPoint, Scientific Consulting

  Jun 2009 - Mar 2012

  Working as CPM and CRA for a Portuguese CRO in more than 20 projects with some of the most known pharmaceutical companies gave me the widen experience in several therapeutically areas and at same time the know-how of all procedures and stages in a clinical project.Experience as CPM in Clinical Trials and Non-interventional StudiesMain Responsibilities/Experience: Client contact; Working as the representative for Clinical on inter-department project teams; Assist in planning and design of protocol; Tracking budgets and timelines; Team Management; Management of monitoring activities and Reporting; Competent Authorities/Ethics Committees submission; Site submission; Other management tasks.Therapeutic areas: Oncology, Neurology, Gastroenterology, Pneumology, Endocrinology and Autoimmune diseaseAdditional Responsibility: Train/support clinical team - Internship supervisor of CRA trainee. Show less Experience as CRA in Clinical Trials and Non-interventional StudiesMain Responsibilities/Experience: Feasibility; Review and negotiation of Contracts and Regulatory Documents; Competent Authorities/Ethics Committees submission; Amendments to Competent Authorities/Ethics Committees; Site submission, Site Initiation Visits; Monitoring Visits; Close-Out Visits; Management of payments to the sites; Pharmacy Visits; Teleconference/Meetings with International teams; Investigators Meetings.Therapeutic areas: Cardiovascular, Autoimmune disease, Dermatology, Pneumology, Neurology, Infectiology, Alergology and Oncology.Others: Familiarized with SOPs from different clients / Experience with different eCRF platforms (i.e. Viedoc, InForm, eClinical) and Clinical Trials Management Systems. Show less The Information Analysis and Management Technician in health reports to the Coordinator of Department about the state of the project, training and support to the teams in field, and recommendations about future planning and development of resources. Providing these services in an effective and efficient manner will ensure the good implementation of projects in epidemiologyc area, optimizing resources.Studies in the following domains:• Health Care/ Nutrition - Hydration (Managing a team of 16 members); • Endocrinology - Diabetes mellitus (Managing a team of 25 members);• Cardiology - Atrial fibrillation (Managing a team of 70 members);• Pain medicine – Neuropathic pain (Managing a team of 12 members). Show less

  • Clinical Project Manager - CPM

    Mar 2010 - Mar 2012

  • Clinical Research Associate - CRA

    Feb 2008 - Mar 2012

  • Information Analysis and Management Technician

    Jun 2009 - Mar 2010
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  Quintiles

  Mar 2012 - Aug 2015

  Main Responsibilities/Experience:Maintain and manage SSU data tracking entries in database; Work with sponsors and internal team members to establish regulatory requirements and contracts necessary for start up; Review and negotiate regulatory documents and contracts with sites and sponsors for agreement on wording and budgets;Work with Clinical Operations, Project Management and Site; Identification on SSU project specific status and deliverables;Facilitate process improvement efforts both within the department and in cooperation with other departments;May be assigned as ad hoc member to various process improvement working groups;Participate in sales presentation and proposal development; may provide input into budget development;Participate in mentorship and training of less experienced staff;May participate in feasibility and/or site identification activities.Participate on Regional activities to improve Quality processes. Show less

  • Global Clinical Project Manager

    Sept 2014 - Aug 2015

  • Regulatory Start-Up Specialist - RSU Specialist 2 / RSU Country Lead

    Dec 2012 - Sept 2014

  • Regulatory Start-Up Specialist - RSU Specialist

    Mar 2012 - Dec 2012
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  Chiltern

  Aug 2015 - Oct 2016

  Regional Clinical Project Manager (based on MSD)

  Responsible for project deliverable and performance in assigned therapeutic areas and geographic area within the region. The RCPM will be the primary point of contact between HQ and Country Operations and develops understanding of country requirements to proactively serve and coordinate country needs. The RCPM partners closely with HQ functional areas and builds meaningful relationships and networks across the organization.

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  MSD Portugal

  Nov 2016 - now

  The Associate Director, Metrics and Reporting within Metrics, Analytics & Performance (MAP) collaborates with regional, global and functional area leaders and subject matter experts (SMEs) to develop, maintain, and communicate information to support strategic decisions, improve planning, and monitor performance within GCTO. This role is primarily accountable for the end to end performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally. Responsible for project deliverable and performance in assigned therapeutic areas and geographic area within the region. The RCPM will be the primary point of contact between HQ and Country Operations and develops understanding of country requirements to proactively serve and coordinate country needs. The RCPM partners closely with HQ functional areas and builds meaningful relationships and networks across the organization.

  • Associate Director, GCTO - Metrics, Analytics & Performance (MAP)

    Nov 2020 - now

  • Clinical Research Manager

    Jun 2018 - Nov 2020

  • Regional Clinical Project Manager

    Nov 2016 - Jun 2018