Sso Study Start-up Manager

3 semanas atrás

Oeiras, Portugal Novartis Tempo inteiro

100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine - imagine the impact you could have as SSO Study Start-Up Manager #GCO
The SSO Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in a standalone country, OPC (operating country) or satellite country. Leads all SSU activities of assigned projects in close collaboration with SSO Feasibility Manager and SSO Site Partnership Manager as well as the global study team. In satellite countries acts as primary back-up and deputy of the country manager.
Your responsibilities include, but are not limited to:

- Supports and collaborates with SSO Study Start-Up Team Lead, SSO Country Head Portfolio / SSO Cluster Head Portfolio in country SSU strategy and global study team to ensure SSU timelines and deliverables are met according to country commitment
- Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable and also ensures that study start-up activities are conducted and completed on time, including preparation of IRB/IEC submission packages, review of Informed Consent Forms
- Coordinates timely response to deficiency letters in close collaboration with local and global stakeholders as well as reportable events and notifications to IRB/IEC and Health Authorities as applicable
- Accountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness and ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
- Implements innovative and efficient processes which are in line with Novartis strategy and supports study feasibility in close collaboration with Feasibility Manager and Site Partnership Manager as well as the global study team.
- Leads site selection in collaboration with Portfolio Team Lead and Clinical Project Manager if already assigned and in satellite countries oversees local vendor selection and performance as needed. Serves as main contact for quality/compliance issues in SSU phase, escalating as necessary
- Ensures sites are prepared for “Green Light” and ensures all documentation is in place for initial and subsequent drug release. Responsible for review and sign off of the site “Green Light” and oversees local SSU team activities in assigned studies to achieve start-up timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and local and international regulations
- Leads/chairs local SSU team meetings in assigned studies, participates in global study team meetings, as required and leads the development of country site initiation and patient enrolment plans together with SSU CRA, CPM and SSU

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

What you’ll bring to the role:
Required Experience & Qualifications:

- A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable
- Fluent in both written and spoken English, local language as needed
- Minimum 5 years’ experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials
- Capable of leading in a matrix environment, without direct reports
- Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
- Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
- Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
- Strong interpersonal, negotiation and conflict resolution skills and communicates effectively in a local/global matrixed environment

GCO
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an

  • Sso Study Start-up Manager

    1 semana atrás

    Oeiras, Lisboa, Portugal Novartis Tempo inteiro

    100,000+ That's how many patients participate in our clinical trials at any given time. GCO is Novartis' powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine -...

  • Regulatory & Start-up Trainee

    2 meses atrás

    Oeiras, Portugal IQVIA Tempo inteiro

    Job Overview Perform 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. Essential Functions - Under general supervision, serve...

  • Regulatory & Start-up Trainee

    1 semana atrás

    Oeiras, Lisboa, Portugal IQVIA 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.Essential Functions Under general supervision, serve as...

  • Regulatory and Start Up Specialist

    2 meses atrás

    Oeiras, Portugal IQVIA Tempo inteiro

    **Job Overview** Perform 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. **Portuguese and English language...

  • Regulatory and Start Up Specialist

    Há 9 horas

    Oeiras, Portugal IQVIA Tempo inteiro

    **Job Overview** Perform 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. **Portuguese and English language...

  • Sr Clinical Trial Assistant

    2 semanas atrás

    Oeiras, Portugal IQVIA Tempo inteiro

    Clinical 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...

  • Clinical Trial Assistant 2

    1 semana atrás

    Oeiras, Lisboa, Portugal IQVIA Tempo inteiro

    Clinical Trial Administrator, Single Sponsor dedicatedJob 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 to...

  • Senior Global Clinical Trial Assistant- Portugal

    1 semana atrás

    Oeiras, Portugal IQVIA Tempo inteiro

    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 Functions - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and...

  • Local Trial Manager, Single Sponsor Dedicated, home based anywhere in Portugal

    1 semana atrás

    Oeiras, Lisboa, Portugal Pharmiweb Tempo inteiro

    The RoleAs Local Trial Manager, you will be in charge of overseeing international studies in various therapeutic areas, managing project operations to fulfill contractual obligations. As the main contact person, you will lead, manage, and organize clinical trials from start to finish at a country level, following ICH-GCP and local...

  • Clinical Project Manager- 6 Months Contract- One

    1 semana atrás

    Oeiras, Portugal IQVIA Tempo inteiro

    Job Overview Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs,...

  • Analyst Rwe

    2 meses atrás

    Oeiras, Portugal IQVIA Tempo inteiro

    With approximately 85,000 employees in more than 100 countries, IQVIA is in a truly unique position to be able to support companies seeking to improve real-world patient outcomes and enhanced clinical trial outsourcing through treatment innovations, care provision and access. With a broad range of healthcare information, technology and service offerings,...

  • Rwe/heor Consultant

    2 meses atrás

    Oeiras, Portugal IQVIA Tempo inteiro

    With approximately 85,000 employees in more than 100 countries, IQVIA is in a truly unique position to be able to support companies seeking to improve real-world patient outcomes and enhanced clinical trial outsourcing through treatment innovations, care provision and access. With a broad range of healthcare information, technology and service offerings,...

  • Rwe/heor Consultant

    2 semanas atrás

    Oeiras, Portugal IQVIA Tempo inteiro

    With approximately 85,000 employees in more than 100 countries, IQVIA is in a truly unique position to be able to support companies seeking to improve real-world patient outcomes and enhanced clinical trial outsourcing through treatment innovations, care provision and access. With a broad range of healthcare information, technology and service offerings,...

  • Rwe/heor Consultant

    1 semana atrás

    Oeiras, Lisboa, Portugal IQVIA Tempo inteiro

    With approximately 85,000 employees in more than 100 countries, IQVIA is in a truly unique position to be able to support companies seeking to improve real-world patient outcomes and enhanced clinical trial outsourcing through treatment innovations, care provision and access. With a broad range of healthcare information, technology and service offerings,...

  • Analyst Rwe

    1 semana atrás

    Oeiras, Lisboa, Portugal IQVIA Tempo inteiro

    With approximately 85,000 employees in more than 100 countries, IQVIA is in a truly unique position to be able to support companies seeking to improve real-world patient outcomes and enhanced clinical trial outsourcing through treatment innovations, care provision and access. With a broad range of healthcare information, technology and service offerings,...

  • Centralized Monitor

    2 meses atrás

    Oeiras, Portugal IQVIA Tempo inteiro

    Job Overview Manage the execution of the assigned clinical study (ies) from initiation through to closeout. Ensure that clinical study management and project deliverables are on time and is in accordance with standard operating procedures (SOPs), policies and practices. To provide project related support and assistance across multiple projects, sites and...

  • Business Development Manager

    1 semana atrás

    Oeiras, Lisboa, Portugal Multipessoal Tempo inteiro

    Are you a proactive Business Development Manager? If you excel at showcasing a full B2B product range, this is the right project for you We are hiring a Business Development Manager for a multinational technological company. Define the proper strategy for the assigned vertical markets; Set up a clear customer mapping with target customers; Define which...

  • Marketing Manager

    3 semanas atrás

    Oeiras, Portugal Trib3 Tempo inteiro

    **Our purpose**: We are TRIB3; we bring people together worldwide through next-level workout experiences. We do this through our family of workout studios, our global team of employees & franchise partners and our community of workout warriors. Every member of the TRIB3 family plays a vital role in our mission to build a global fitness community where anyone...

  • Aruba Account Manager

    3 semanas atrás

    Oeiras, Portugal Hewlett Packard Enterprise Tempo inteiro

    Aruba Account Manager - Portugal This role has been designated as ‘Edge’, which means you will primarily work outside of an HPE office. Hewlett Packard Enterprise advances the way people live and work. We bring together the brightest minds to create breakthrough technology solutions, helping our customers make their mark on the world. We’re solving...

  • Operations Specialist Manager

    1 semana atrás

    Oeiras, Portugal IQVIA Tempo inteiro

    **IQVIA Safety Operations** team play an important part in the design, build and execution of end-to-end safety solutions for major pharmaceutical companies and their post market products around the world. We are proud to be an international, diverse team based across the world, with ‘safety hubs’ in Ireland, Poland, Austria, Portugal, Slovakia, Spain,...