Study Start Up Specialist

3 semanas atrás

Lisboa, Portugal TFS HealthScience Tempo inteiro

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

**Join Our Team as a** **Study Start Up Specialist - (home based in Portugal.**

**About this role**

As part of our **Study Start Up** team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The **Study Start Up Specialist** is part of the Site Management and Start Up Unit, within TFS Develop and will function operationally as a member of a Project Team being responsible of startup activities according to company policies, SOPs and regulatory requirements in addition to financial and contractual obligations.

The **Study Start Up Specialist **must contribute to ensure the planned start up plan is executed maximizing the recruitment window of assigned studies. As part of the job function will perform activities associated with feasibility and site identification, study site initiation process, interact with Ethics Committees or deal with investigator contracts.

**Key Responsibilities**:

- Performs the startup activities of assigned studies within a country or region ensuring that those are performed on-time, within the scope and in compliance with ICH/GCP guidelines, SOPs and protocol requirements.
- Collect, review, approve process and track regulatory & investigator documents required for study site activation.
- Prepare and complete regulatory process (IEC/IRBs) including ask for requirements to the EC/IRBSs, prepare and collecting specific documentation, submission and amendments, regulatory fees.
- Collaborate with Regulatory department regarding HA/CA submission/notification.
- Main responsible of ensuring the quality control of documentation included in any submission/notification.
- Adapt Informed Consent documents according to local law and document the process following guidelines and SOPs.
- Ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.

**Qualifications**:

- Bachelor’s Degree preferred
- Good knowledge of GCP/ICH guidelines
- Good Knowledge of applicable regulatory requirements, SOPs and company’s Corporate Standards
- Minimum 1-3 years of relevant clinical experience
- Previous experience with investigator start-up documents and investigative sites is preferred
- Good written and communication skills in English and Portuguese
- Good organizational skills and experience working with cross functional teams
- Strong software and computer skills
- Capable of multi-tasking and working well under pressure to meet deadline coupled with a good understanding of working in a team environment
- Travel within this position is limited

**What We Offer**

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

**A Bit More About Us**

Our journey began over 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East.

Our core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization.

**#Together we make a difference

  • Study Start Up Associate

    1 dia atrás

    Lisboa, Portugal ICON plc Tempo inteiro

    Study Start Up Associate At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation:...

  • Study Start Up Associate

    Há 6 dias

    Lisboa, Lisboa, Portugal ICON plc Tempo inteiro

    Study Start Up Associate - Spanish & Portuguese Speaker - Home BasedAt ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us...

  • Manager, Study Start Up

    Há 6 dias

    Lisboa, Lisboa, Portugal ICON Tempo inteiro

    Manager, Study Start Up - Office Based - Madrid - SpainAt ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an...

  • Study Start Up Associate Ii

    4 semanas atrás

    Lisboa, Portugal ICON Tempo inteiro

    Study Start Up Associate II - Barcelona At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an...

  • Study Start Up Associate Ii

    4 semanas atrás

    Lisboa, Portugal ICON Tempo inteiro

    Study Start Up Associate II At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation:...

  • Study Start Up Associate Ii

    4 semanas atrás

    Lisboa, Portugal ICON plc Tempo inteiro

    Study Start Up Associate II At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation:...

  • Study Start Up Associate Ii

    Há 6 dias

    Lisboa, Lisboa, Portugal ICON Tempo inteiro

    Study Start Up Associate II - BarcelonaAt ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation:...

  • Study Start Up Associate

    2 semanas atrás

    Lisboa, Portugal ICON plc Tempo inteiro

    Study Start Up Associate - Spanish & Portuguese Speaker - Home Based At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and...

  • Manager, Study Start Up

    4 semanas atrás

    Lisboa, Portugal ICON Tempo inteiro

    Manager, Study Start Up - Office Based - Madrid - Spain At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart...

  • Manager, Study Start Up

    4 semanas atrás

    Lisboa, Portugal ICON plc Tempo inteiro

    Manager, Study Start Up - Office Based - Madrid - Spain At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart...

  • Study Start Up Associate Ii

    Há 3 dias

    Lisboa, Portugal ICON plc Tempo inteiro

    Study Start Up Associate II - Home Based - French Speaker - Romenia / UK / Portugal / Spain At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us...

  • Global Clinical Start Up Manager Portugal

    3 semanas atrás

    Lisboa, Portugal Resourcing Life Science Tempo inteiro

    Company DescriptionOur client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a Clinical Start up Manager in PortugalJob OverviewLeading cross-functional project teams...

  • Global Clinical Start Up Manager Portugal

    3 semanas atrás

    Lisboa, Portugal Resourcing Life Science Tempo inteiro

    Company DescriptionOur client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a Clinical Start up Manager in PortugalJob OverviewLeading cross-functional project teams...

  • Global Clinical Start Up Manager Portugal

    Há 6 dias

    Lisboa, Lisboa, Portugal Resourcing Life Science Tempo inteiro

    Company DescriptionOur client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a Clinical Start up Manager in PortugalJob OverviewLeading cross-functional project teams...

  • Sr Start-up Team Mgr

    2 meses atrás

    Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    PPD, a part of Thermo Fisher Scientific, is a leading global contract research organization focused on delivering life-changing therapies. Our mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people....

  • Senior Start-up Specialist

    3 semanas 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 paired...

  • Robotic Surgery Start-up Specialist

    Há 5 dias

    Lisboa, Portugal Medtronic Tempo inteiro

    The surgical robotics utilization team manages all aspects of system installation, start-up, customer training, account analysis, drive and optimize the robotic program. Placement of a HUGO surgical robot in the hospital requires full-time support for an account specific period to ensure successful integration into the hospital’s service lines. The...

  • Sr Start-up Team Mgr

    Há 6 dias

    Lisboa, Lisboa, Portugal Thermo Fisher Scientific Tempo inteiro

    PPD, a part of Thermo Fisher Scientific, is a leading global contract research organization focused on delivering life-changing therapies. Our mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it's you We know that meaningful results not only require the right approach, but also the right people. We...

  • Start-up Specialist

    2 semanas atrás

    Lisboa, Portugal Fortrea - Organic Tempo inteiro

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Regulatory and Start Up Specialist

    Há 6 dias

    Lisboa, Lisboa, Portugal Novasyte Tempo inteiro

    Job OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Fluent in both Portuguese and English. At least 1 years'...