Associate Manager, Clinical Trials Regulatory Management
1 semana atrás
.Associate Manager, Clinical Trials Regulatory Management (m/w/d) - Home-based, EMEA Lisboa Associate Manager, Clinical Trials Regulatory Management (m/w/d) - Home-based, EMEALisboa Lisbon, Lisbon, Portugal Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects. RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complex Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers. Prepares and maintains core clinical trial submission dossiers in accordance with applicable regulatory requirements. Ability to write scientific documents e. g. Investigational Medicinal Product Dossier, clinical trial justifications with minimum support of senior staff May strategically plan and perform European centralized submissions and facilitate global submissions May provide support on regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs) Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met. Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or IQVIA). Deliver regulatory training/presentations as required. May perform additional tasks as deemed appropriate by Line Manager REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Good understanding of the regulations, directives and guidance supporting clinical Research and Development Demonstrates comprehensive regulatory/technical expertise Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach Strong ownership and oversight skills Demonstrated skills in chairing small meetings Ability to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervision Ability to establish and maintain effective working relationships with- workers, managers and clients Strong software and computer skills, including MS Office applications MINIMUM REQUIRED EDUCATION AND EXPERIENCE Degree in life- related discipline or professional equivalent plus at least 5 years relevant experience* or high school diploma plus at least 9+ years' experience* (*or combination of education, training and experience) EU-CTR knowledge & experience PHYSICAL REQUIREMENTS Extensive use of telephone and-- face communication requiring accurate perception of speech Extensive use of keyboard requiring repetitive motion of fingers Regular sitting for extended periods of time Travel might be required This role is not available for UK visa sponsorship IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry
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Associate Manager, Clinical Trials Regulatory Management
2 semanas atrás
Lisboa, Lisboa, Portugal Tn Portugal Tempo inteiroAssociate Manager, Clinical Trials Regulatory Management (M/W/D) - Home-Based, Emea Lisboa Associate Manager, Clinical Trials Regulatory Management (M/W/D) - Home-Based, EmeaLisboa Lisboa, Lisboa, Portugal col-wideJob Description:Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for...
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Associate Manager, Clinical Trials Regulatory Management
2 semanas atrás
Lisboa, Lisboa, Portugal IQVIA Tempo inteiroAssociate Manager, Clinical Trials Regulatory Management (m/w/d) Home based, EMEA Lisboa Associate Manager, Clinical Trials Regulatory Management (m/w/d)Home based, EMEALisboa Lisbon, Lisbon, Portugal Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects....
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Lisboa, Lisboa, Portugal IQVIA Tempo inteiroRegulatory Manager, Clinical Trials Regulatory ManagementHome based, EMEA Lisboa Regulatory Manager, Clinical Trials Regulatory ManagementHome based, EMEALisboa Lisbon, Lisbon, Portugal Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs...
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Lisboa, Portugal Iqvia Tempo inteiro.Regulatory Manager, Clinical Trials Regulatory Management- Home-based, EMEA Lisboa Regulatory Manager, Clinical Trials Regulatory Management- Home-based, EMEALisboa Lisbon, Lisbon, Portugal Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs...
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Associate Manager, Clinical Trials Regulatory Management
1 semana atrás
Lisboa, Portugal Tn Portugal Tempo inteiro.Associate Manager, Clinical Trials Regulatory Management (M/W/D) - Home-Based, Emea Lisboa Associate Manager, Clinical Trials Regulatory Management (M/W/D) - Home-Based, EmeaLisboa Lisboa, Lisboa, Portugal col-wideJob Description:Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for...
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Associate Manager, Clinical Trials Regulatory Management
1 semana atrás
Lisboa, Portugal Iqvia Tempo inteiroAssociate Manager, Clinical Trials Regulatory Management (m/w/d) - Home-based, EMEA Lisboa Associate Manager, Clinical Trials Regulatory Management (m/w/d) - Home-based, EMEALisboaLisbon, Lisbon, Portugal Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex...
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Associate Manager, Clinical Trials Regulatory Management
1 semana atrás
Lisboa, Portugal Iqvia Tempo inteiroAssociate Manager, Clinical Trials Regulatory Management (m/w/d) - Home-based, EMEA Lisboa Associate Manager, Clinical Trials Regulatory Management (m/w/d) - Home-based, EMEA Lisboa Lisbon, Lisbon, Portugal Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex...
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Lisboa, Portugal Iqvia Tempo inteiroRegulatory Manager, Clinical Trials Regulatory Management- Home-based, EMEA Lisboa Regulatory Manager, Clinical Trials Regulatory Management- Home-based, EMEALisboaLisbon, Lisbon, Portugal Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and...
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Lisboa, Portugal Iqvia Tempo inteiroRegulatory Manager, Clinical Trials Regulatory Management- Home-based, EMEA Lisboa Regulatory Manager, Clinical Trials Regulatory Management- Home-based, EMEA Lisboa Lisbon, Lisbon, Portugal Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and...
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Clinical Trial Associate
2 semanas atrás
Lisboa, Lisboa, Portugal TFS HealthScience Tempo inteiroOverview:TFS HealthScience is excited to be expanding our SRS team and we are looking for an experienced, highly motivated CLINICAL TRIAL ASSOCIATE who shares our vision of providing clinical research excellence. Our SRS team is a highly experienced international group of professionals led by an industry expert.We are a leading global mid-size Contract...
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Clinical Trials Associate
1 semana atrás
Lisboa, Portugal TFS HealthScience Tempo inteiroOverview: TFS HealthScience is excited to be expanding our SRS team and we are looking for an experienced, highly motivated **Clinical Trial Associate (CTA)** who shares our vision of providing clinical research excellence. Our **SRS** team is a highly experienced international group of professionals led by an industry expert. We are a leading global...
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Clinical Trials Associate
2 semanas atrás
Lisboa, Lisboa, Portugal TFS HealthScience Tempo inteiroOverview:TFS HealthScience is excited to be expanding our SRS team and we are looking for an experienced, highly motivated Clinical Trial Associate (CTA) who shares our vision of providing clinical research excellence. Our SRS team is a highly experienced international group of professionals led by an industry expert.We are a leading global mid-size Contract...
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Sr Clinical Trial Assistant
2 semanas atrás
Lisboa, Lisboa, Portugal IQVIA Tempo inteiroClinical Trial Administrator, Single Sponsor dedicated Job Overview: CTA performs daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. By assisting in the coordination and administration of the study activities from the start up...
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Clinical Trial Associate
2 semanas atrás
Lisboa, Portugal TFS HealthScience Tempo inteiroOverview: TFS HealthScience is excited to be expanding our **SRS** team and we are looking for an experienced, highly motivated **CLINICAL TRIAL ASSOCIATE** who shares our vision of providing clinical research excellence. Our **SRS **team is a highly experienced international group of professionals led by an industry expert. We are a leading global...
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Senior Global Clinical Trial Assistant- Portugal
2 semanas atrás
Lisboa, Lisboa, Portugal Tn Portugal Tempo inteiroSenior Global Clinical Trial Assistant- Portugal Lisboa Senior Global Clinical Trial Assistant- PortugalLisboa Lisboa, Lisboa, Portugal col-wideJob Description:Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential...
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Clinical Trial Assistant 2
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Lisboa, Portugal Novasyte Tempo inteiroClinical Trial Administrator, Single Sponsor dedicated Job Overview: CTA performs daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. By assisting in the coordination and administration of the study activities from the start up...
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Senior Global Clinical Trial Assistant- Portugal
1 semana atrás
Lisboa, Portugal Tn Portugal Tempo inteiroSenior Global Clinical Trial Assistant- Portugal Lisboa Senior Global Clinical Trial Assistant- Portugal Lisboa Lisboa, Lisboa, Portugal col-wideJob Description:Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery....
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Senior Global Clinical Trial Assistant- Portugal
1 semana atrás
Lisboa, Portugal Tn Portugal Tempo inteiroSenior Global Clinical Trial Assistant- Portugal Lisboa Senior Global Clinical Trial Assistant- PortugalLisboa Lisboa, Lisboa, Portugal col-wideJob Description:Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential...
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Clinical Trials Assistant
3 semanas atrás
Lisboa, Portugal TFS HealthScience Tempo inteiroOverview: TFS HealthScience is excited to be expanding our **CTA** team and we are looking for an experienced, highly motivated **CLINICAL TRIAL ASSOCIATE** who shares our vision of providing clinical research excellence. Our **SRS **team is a highly experienced international group of professionals led by an industry expert. We are a leading global...
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Clinical Trial Manager
2 meses atrás
Lisboa, Portugal Labcorp Tempo inteiro**Labcorp Drug Development** As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services...
