Talent.com
Esta oferta de trabalho já não está disponível no seu país.
IHCRA

IHCRA

ICONPortugal
Há 13 dias
Descrição do cargo

As a CTA / IH CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

This role is responsible for comprehensive trial and site administration. Under the oversight of the Start Up Lead, the person prepares, collates, distributes and archives clinical documents.

The CTA / IH CRA supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.

The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB / ERC and Health Authorities.

What you will be doing :

  • Trial and site administration

Track (e.g. essential documents) and report (e.g. Safety Reports)

  • Ensure collation and distribution of study tools and documents
  • Update clinical trial databases (CTMS) and trackers
  • Clinical supply & non-clinical supply management, in collaboration with other country
  • roles

  • Manage Labeling requirements and coordinate / sign translation change request
  • Document management
  • Prepare documents and correspondence

  • Collate, distribute / ship, and archive clinical documents, e.g. eTMF
  • Assist with eTMF reconciliation
  • Execute eTMF Quality Control Plan
  • Update manuals / documents (e.g., patient diaries, instructions)
  • Document proper destruction of clinical supplies.
  • Prepare Investigator trial file binders
  • Obtain translations of documents
  • Regulatory & Site Start-Up responsibilities
  • In a timely manner, provide to and collect from investigators forms / lists for site evaluation / validation, site start-up and submissions

  • Obtain, track and update study insurance certificates
  • Support preparation of submission package for IRB / ERC and support regulatory agencies submissions.
  • Publish study results for GCTO and RA where required per local legislation
  • Budgeting, Agreement and Payments
  • Develop, control, update and close-out country and site budgets (including Split site budget)

  • Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
  • Track and report contract negotiations
  • Update and maintain contract templates (in cooperation with Legal Department)
  • Calculate and execute payments (to investigators, vendors, grants)
  • Ensure adherence to financial and compliance procedures
  • Monitor and track adherence and disclosures,
  • Maintain tracking tools
  • Meeting Planning
  • Organize meetings (create & track study memos / letters / protocols)

  • Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
  • You are :

  • Completed job training (office management, administration, finance, health care preferred) or B.A. / B.S. (Life Science preferred) or equivalent healthcare experience
  • Minimum 1 - 2 years in Clinical Research or relevant healthcare experience
  • Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
  • Good understanding of Global, Country / Regional Clinical Research Guidelines and ability to work within these guidelines
  • Hands on knowledge of Good Documentation Practices
  • Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
  • ICH-GCP Knowledge appropriate to role
  • Effective time management, organizational and interpersonal skills, conflict management
  • Effective communication with external customers (e.g. sites and investigators)
  • High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
  • Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
  • Demonstrates commitment to Customer focus, both internally and externally.
  • Able to work independently
  • Proactive attitude to solving problems / proposing solutions
  • What ICON can offer you :

    Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

    In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

    Our benefits examples include :

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
  • Visit our careers website to read more about the benefits of working at ICON : https : / / careers.iconplc.com / benefits

    At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

    https : / / careers.iconplc.com / reasonable-accommodations

    Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

    Criar um alerta de emprego para esta pesquisa

    Ihcra • Portugal

    Vagas relacionadas
    • Divulgado
    Sr Account Director, Business Development RWE (Patient Centered Research / Data Analytics)

    Sr Account Director, Business Development RWE (Patient Centered Research / Data Analytics)

    Thermo Fisher ScientificPortugal, Portugal
    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale.Join our colleagues in bringing our Mission to life - enabling our customers to make the ...Mostre maisÚltima atualização: há mais de 30 dias
    • Divulgado
    • Novo!
    Senior AI Research Engineer, Model Inference

    Senior AI Research Engineer, Model Inference

    TetherPortugal
    Join Tether and Shape the Future of Digital Finance.At Tether, we're not just building products, we're pioneering a global financial revolution. Our cutting-edge solutions empower businesses—from ex...Mostre maisÚltima atualização: 11 horas atrás
    QA / QC Analyst (M / F)

    QA / QC Analyst (M / F)

    fortilPORTUGAL
    Quick Apply
    With 30 offices across 14 countries, Fortil fosters entrepreneurial freedom and the empowerment of individual potential.Roles & Access (R&A) Optimization and Master Data Creation initiatives within...Mostre maisÚltima atualização: há mais de 30 dias
    • Divulgado
    Regional Business Intelligence Director

    Regional Business Intelligence Director

    Teleperformance PortugalPortugal, Portugal
    As the Regional Business Intelligence Director for the MLH Region, you’ll play a critical role in driving data-led decision making and performance insights across multiple countries.Aligned with th...Mostre maisÚltima atualização: há mais de 30 dias
    • Divulgado
    FinCrime Risk Manager (Advisory)

    FinCrime Risk Manager (Advisory)

    RevolutPortugal, Portugal
    FinCrime Risk Manager (Advisory).FinCrime Risk Manager (Advisory).Get AI-powered advice on this job and more exclusive features. People deserve more from their money.More visibility, more control, a...Mostre maisÚltima atualização: há mais de 30 dias
    • Divulgado
    (Associate) Medical Director - Oncology, EMEA

    (Associate) Medical Director - Oncology, EMEA

    Thermo Fisher ScientificPortugal, Portugal
    Associate) Medical Director - Oncology, EMEA.At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. We provide our teams with the resources need...Mostre maisÚltima atualização: 8 dias atrás
    • Divulgado
    Senior / Medical Director (Ophthalmology) 0.5 FTE

    Senior / Medical Director (Ophthalmology) 0.5 FTE

    TFS HealthSciencePortugal, Portugal
    Senior / Medical Director (Ophthalmology) 0.Join to apply for the Senior / Medical Director (Ophthalmology) 0.The Senior / Medical Director is a key member of the Project Delivery team, working independe...Mostre maisÚltima atualização: há mais de 30 dias
    • Novo!
    Quality & Regulatory Affairs (QRA) Specialist (FT - Remote Europe)

    Quality & Regulatory Affairs (QRA) Specialist (FT - Remote Europe)

    RetinAI MedicalPT
    Quick Apply
    Ikerian AG (formerly RetinAI Medical).Our mission is to enable the right decisions sooner in healthcare, through transformative AI & data management solutions for disease screening and monitori...Mostre maisÚltima atualização: 5 horas atrás
    • Divulgado
    MIA Data Engineer - Merchant Intelligence Team (Remote)

    MIA Data Engineer - Merchant Intelligence Team (Remote)

    ConstructorPortugal, Portugal
    Constructor is the next-generation platform for search and discovery in e-commerce, built to explicitly optimize for metrics like revenue, conversion rate, and profit. Our search engine is entirely ...Mostre maisÚltima atualização: há mais de 30 dias
    • Divulgado
    Senior Integration Architect

    Senior Integration Architect

    Descompagnons Trabalho Temporário LdaLeiria, Leiria, Portugal
    Senior Integration Architect – Long Term Contract (Remote, Portugal-based).You will play a key role in designing and implementing. This role requires deep experience in.Occasional travel may be requ...Mostre maisÚltima atualização: 22 dias atrás
    Clinical Trial Manager

    Clinical Trial Manager

    ICONRemote, Portugal
    As a CTM you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. This role is primarily accountable for the end to end perfor...Mostre maisÚltima atualização: 12 dias atrás
    Sr PPC Specialist

    Sr PPC Specialist

    Action1PT
    Quick Apply
    Action1 is an autonomous endpoint management platform that is cloud-native, infinitely scalable, highly secure, and configurable in 5 minutes—it just works and is always free for the first 200 endp...Mostre maisÚltima atualização: 26 dias atrás
    Senior Product Designer - Analytics

    Senior Product Designer - Analytics

    ConstructorPT
    Quick Apply
    In this role, you’ll join the MIA (Merchant Intelligence & Analytics) team, where you’ll help shape the tools that enable merchandisers to make data-informed decisions.These products support ev...Mostre maisÚltima atualização: 9 dias atrás
    • Divulgado
    Portfolio Director, Scientific

    Portfolio Director, Scientific

    Envision Pharma GroupPortugal, Portugal
    Work shouldn't just be something we do; it should have a purpose.At Envision, we believe in creating life-changing outcomes through the work we do with our clients, giving back to our communities, ...Mostre maisÚltima atualização: 18 dias atrás
    Lead Generation Manager (LinkedIn channel) (IR-347)

    Lead Generation Manager (LinkedIn channel) (IR-347)

    IntellectsoftPT
    Quick Apply
    We operate across North America, Latin America, the Nordic region, the UK, and Europe.We specialize in industries like Fintech, Healthcare, EdTech, Construction, Hospitality, and more, partnering w...Mostre maisÚltima atualização: 7 dias atrás
    • Divulgado
    (Associate) Medical Director Pulmonology, EMEA

    (Associate) Medical Director Pulmonology, EMEA

    Thermo Fisher ScientificPortugal, Portugal
    Associate) Medical Director Pulmonology, EMEA – Join to apply for the.Associate) Medical Director Pulmonology, EMEA.Work Schedule : Standard (Mon-Fri). Environmental Conditions : Office.At Thermo Fish...Mostre maisÚltima atualização: 10 dias atrás
    • Divulgado
    Consulting Director

    Consulting Director

    Envision Pharma GroupPortugal, Portugal
    Leading with strategy, delivering with impact.Work shouldn’t just be something we do; it should have a purpose.At Envision, we believe in creating life-changing outcomes through the work we do with...Mostre maisÚltima atualização: 3 dias atrás
    • Divulgado
    Principal Data Scientist - Price Imputation

    Principal Data Scientist - Price Imputation

    NielsenIQPortugal, Portugal
    Principal Data Scientist - Price Imputation role at NielsenIQ.Principal Data Scientist - Price Imputation.As an individual contributor within the Consumer Data Science team, you will serve as the S...Mostre maisÚltima atualização: 24 dias atrás