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, EMEA Lisboa Lisbon, Lisbon, Portugal Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects.RESPONSIBILITIESActs as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complexAbility 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 staffMay strategically plan and perform European centralized submissions and facilitate global submissionsMay 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 ManagerREQUIRED KNOWLEDGE, SKILLS AND ABILITIESGood understanding of the regulations, directives and guidance supporting clinical Research and DevelopmentDemonstrates comprehensive regulatory/technical expertiseGood negotiating skills and the ability to identify and resolve issues, using flexible adaptable approachStrong ownership and oversight skillsDemonstrated skills in chairing small meetingsAbility to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervisionAbility to establish and maintain effective working relationships with- workers, managers and clientsStrong software and computer skills, including MS Office applicationsMINIMUM REQUIRED EDUCATION AND EXPERIENCEDegree 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 & experiencePHYSICAL REQUIREMENTSExtensive use of telephone and-- face communication requiring accurate perception of speechExtensive use of keyboard requiring repetitive motion of fingersRegular sitting for extended periods of timeTravel might be requiredThis role is not available for UK visa sponsorshipIQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at#J-18808-Ljbffr
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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 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 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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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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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
Há 7 dias
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
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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
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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
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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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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
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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...
