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Clinical Research Spc - Portuguese Nativ

Liason with quality team, production team, clinical team (~20 people) - Lifecycle management of Medicinal Products for Human use, Skills on Regulatory affairs (EudraLex Vol.2), Market access, Pharmacovigilance and quality - Liaison with Health Authorities, scientific partnerships with external experts, medical and scientific bodies, Data Monitoring Committee (DMC), government organisations, etc. Coordinating meetings and activities. - Follow up of inspections with Health Authorities in the scope implementation of aseptic procedure and manufacturing authorizations for Medicinal Products for Human use and Experimental Medicines. CAPA tracking and implementation. Development of SOPs in regulamentary affairs. - Pharmacovigilance of Medicinal Products for Human use, report of ICSRs; validation of PSURs, internal audits and external inspections. - Project management of Interventional Clinical Studies – Areas: Neurology; Cardiology and Oncology (Imaging Phase 3 and Phase 4 Clinical Trials with IMP; Medical Devices; Investigator’s Interventional and non-Interventional Studies without IMP) Clinical Trials Regulatory affairs (National and European legislation) Liaison with Health Authorities and preparation of all of the requested documentation (CTA, ICFs, Protocol, IMP information, labels, and Sponsor Files according to GMPs and ICH-GCP) - Preparation of Trial Master Files and Investigator Site Files according to ICH- GCP; - Preparation of budget analysis, risk assessment, clinical SOPs, project and monitoring plans for Clinical Trials; Identification and qualification of Clinical Trials Suppliers - Preparation of audits for Medicinal Products for Human use related with Annex 3 (Radiopharmaceuticals) and Experimental. Medicines according with Annex 13 (Manufacture of Investigational Medicinal Products) from Eudralex vol 4 – GMPs - eCRF Design and Validation with Data Managers Team according with 21 CRF part 11 and GCDMP - Team training and management of 4 people.

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$5/hr Ongoing

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Liason with quality team, production team, clinical team (~20 people) - Lifecycle management of Medicinal Products for Human use, Skills on Regulatory affairs (EudraLex Vol.2), Market access, Pharmacovigilance and quality - Liaison with Health Authorities, scientific partnerships with external experts, medical and scientific bodies, Data Monitoring Committee (DMC), government organisations, etc. Coordinating meetings and activities. - Follow up of inspections with Health Authorities in the scope implementation of aseptic procedure and manufacturing authorizations for Medicinal Products for Human use and Experimental Medicines. CAPA tracking and implementation. Development of SOPs in regulamentary affairs. - Pharmacovigilance of Medicinal Products for Human use, report of ICSRs; validation of PSURs, internal audits and external inspections. - Project management of Interventional Clinical Studies – Areas: Neurology; Cardiology and Oncology (Imaging Phase 3 and Phase 4 Clinical Trials with IMP; Medical Devices; Investigator’s Interventional and non-Interventional Studies without IMP) Clinical Trials Regulatory affairs (National and European legislation) Liaison with Health Authorities and preparation of all of the requested documentation (CTA, ICFs, Protocol, IMP information, labels, and Sponsor Files according to GMPs and ICH-GCP) - Preparation of Trial Master Files and Investigator Site Files according to ICH- GCP; - Preparation of budget analysis, risk assessment, clinical SOPs, project and monitoring plans for Clinical Trials; Identification and qualification of Clinical Trials Suppliers - Preparation of audits for Medicinal Products for Human use related with Annex 3 (Radiopharmaceuticals) and Experimental. Medicines according with Annex 13 (Manufacture of Investigational Medicinal Products) from Eudralex vol 4 – GMPs - eCRF Design and Validation with Data Managers Team according with 21 CRF part 11 and GCDMP - Team training and management of 4 people.

Skills & Expertise

Clinical ResearchClinical TrialsGovernmentMonitoringPharmacovigilancePortuguese TranslationRegulatory Affairs

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