Sso Feasibility Manager

hace 2 semanas

Barcelona, España Novartis A tiempo completo

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 Feasibility Manager #GCO
Accountable for the oversight and coordination of program and study level (re-)feasibility assessments in the country or extended country group (OPCs & satellite countries), in collaboration with program and/or trial feasibility teams, in compliance with Novartis processes, GCP, ICH and regulatory requirements. This position is key to establish good communication and professional relationships with clinical investigators and company stakeholders on country/cluster/hub/global level
Closely collaborates with Study & Site Operations and relevant medical/clinical functions to ensure successful allocation, realistic country targets, recruitment according to planned timelines, early identification of risks and opportunities as well as potential delays and mitigation plan.
Your responsibilities include, but are not limited to:
Single point of contact for communication between Clinical Operations Program Managers / Clinical Operations Program Head, country/extended country group Study & Site teams and local relevant medical/clinical functions for all requests for program/study feasibility
Coordinates the feasibility activities on country/extended country group level by ensuring:
Site identification and selection, trial feasibility evaluation
Collates/validates the list of potential sites by utilizing internal and external data (e.g. historical data, individual knowledge within local Study & Site Team and relevant medical/clinical functions, internal and external databases)
Manages the study specific feasibility questionnaire and sends to all participating sites together with any supporting documentation, if applicable
Follows up with sites to ensure questionnaires are answered and any additional feedback is obtained
Assess the clinical feasibility of implementing a clinical trial protocol based on regional/local medical practice using physician interviews, local databases (RWE, payer data, patient association feed-back, etc.) and analysis of the competitive environment
Enters feedback into global database if applicable (e.g. CLIP).
Collects, analyses, and interprets data to provide comprehensive proposals and timelines for country / extended country group allocation of clinical programs and assigned trials
Responsible for early identification for potential risks and opportunities as well as potential synergies and back-up strategies within the country/extended country group
Closely collaborates with the Study & Site team to ensure fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and robust recruitment mitigation plan. Co-own start-up phase and the recruitment plan for development clinical trials with the Study & Site Operations.

**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:

- Timely submission and delivery of high-quality clinical trial documentation/data
- Performance against study commitments at the country/cluster/hub level, including delivery of studies per defined timelines (including study close out), number of patients and quality
- Delivery of study milestones in adherence to prevailing legislation, GCP, Ethical Committee and SOP requirements

Desirable requirements:

- Minimum 5 years’ experience in clinical research in a role that oversees (project management) and/or with monitoring clinical trials
- 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

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 unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest me

  • Business Development Manager Iberia

    hace 4 semanas

    Barcelona, España MCR International A tiempo completo

    LAG-2308-177 BUSINESS DEVELOPMENT MANAGER IBERIA BARCELONA - Purpose of the role The Business Development Manager is responsible for evaluating and analyzing new business opportunities to assess their potential profitability. They work closely with the sales team to identify potential customers and evaluate their needs. The Business Development Manager...

  • Online Sample Manager

    hace 5 días

    Barcelona, España Blu Selection A tiempo completo

    For this position, our client is looking for an online sample manager to join their team providing business insights focused on the African market for a broad variety of consumer markets. Tasks Your responsibilities and impact working as an online sample manager will be: - Taking handling and taking care of incoming quotation requests at a very rapid...

  • IT Manager

    hace 4 semanas

    Barcelona, España Dragons Group A tiempo completo

    **Description**: **Position overview** You will be handling all IT tasks and systems administration, researching and evaluating emerging technologies, and tracking and maintaining hardware and software inventory in order to make us even more efficient. **Responsibilities** - Analyze departmental needs, identify vulnerabilities, and boost productivity,...

  • Product Manager

    hace 4 semanas

    Barcelona, España Q-Tech A tiempo completo

    The Client Our client is a SaaS FinTech company, focused on providing powerful and flexible software solutions for the commercial real estate debt market. This platform scales business faster and more efficiently. It is a company with a multinational presence (Spain, Germany, Switzerland...), and you will be bringing yourself and your career to their...

  • Business Development Manager

    hace 4 semanas

    Barcelona, España MCR International A tiempo completo

    **CBS-2204-92** **BUSINESS DEVELOPMENT MANAGER - INHOUSE CONSULTANT** **BARCELONA** The professional is responsible for evaluating and analyzing new business opportunities to assess their potential profitability. They work closely with the sales team to identify potential customers and evaluate their needs. The professional uses market research and...

  • It Applications Manager 1

    hace 4 semanas

    Barcelona, España Grifols, S.A A tiempo completo

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...

  • Project Manager

    hace 4 semanas

    Barcelona, España Universal Kraft A tiempo completo

    The Universal Kraft group has been actively developing renewable energy solutions for over 20 years. Our projects span from small hydro, wind, and solar to waste-to-energy, water treatment, and energy storage solutions, including green Hydrogen and green Ammonia. With offices in the United Kingdom, Spain, Portugal, and Sweden, we are continuously expanding,...

  • IT Operations Manager

    hace 4 días

    Barcelona, España AXA Partners A tiempo completo

    Are you looking for a new challenge? In Axa Partners we are looking for our next IT Operations Manager! AXA Partners aims at becoming AXA Group preferred networks & Service Company and a powerhouse for partnerships development as a founding entity of AXA Partners. A key enabler for this business transformation will be the IT Operations Tribe in charge of...

  • Internal Controls

    hace 4 semanas

    Barcelona, España Eaton Corporation A tiempo completo

    **Job Resposabilities**: The Compliance Manager for the Electrical EMEA region will be focused on driving compliance efforts throughout the business. The incumbent will monitor financial activities for adherence with Eaton policy, internal control standards, and U.S. Generally Accepted Accounting Principles (GAAP). The Manager will work closely with the...

  • Engineering Project Manager, Robotics Deployment

    hace 4 semanas

    Barcelona, España Amazon Spain Services, S.L.U. A tiempo completo

    Bachelor’s degree in Engineering, other technical field, or equivalent practical experience - Experience within a project team and engineering contractors in an operational environment - Ability to provide continuous improvement on deployment efficiency and establishing processes Amazon is seeking a business-oriented Engineering Project Manager to...

  • Product Owner B2B 1

    hace 4 semanas

    Barcelona, España ISDIN A tiempo completo

    Mission To contribute to the Company’s results by managing the product development process. Functions Coordinate internal software developers and third parties/vendors for the flawless execution of projects Define project scope and schedule while focusing on regular and timely delivery of value Organize and lead project status and working meetings Manage...

  • Senior Solution Designer

    hace 4 semanas

    Barcelona, España Swisslog A tiempo completo

    Responsibilities Key Responsibilities Participation in solution-finding process at local/European level Technical feasibility (Go-NoGo or change of solution) Able to analyze complex customer’s business data and processes Work with customers and internal stakeholders to develop the appropriate intralogistics concepts and solution for medium to...

  • Skin Care Formula Development Manager

    hace 4 semanas

    Barcelona, España Knewin A tiempo completo

    The Opportunity Aligned with Company strategy developtment new Skin Care formula, for different brands of the company, supporting and increasing the quality and prestige of our products. What you'll get to do Formulation of skin care cosmetic products Determines stability of formulations and ensures commercial feasibility Assures that all testing to...

  • IT Operations Manager

    hace 4 días

    Barcelona, España AXA Group A tiempo completo

    Are you looking for a new challenge? In Axa Partners we are looking for our next IT Operations Manager! AXA Partners aims at becoming AXA Group preferred networks & Service Company and a powerhouse for partnerships development as a founding entity of AXA Partners. A key enabler for this business transformation will be the IT Operations Tribe in charge of...

  • IT Operations Manager

    hace 3 días

    Barcelona, España AXA Group A tiempo completo

    Are you looking for a new challenge? In Axa Partners we are looking for our next IT Operations Manager! AXA Partners aims at becoming AXA Group preferred networks & Service Company and a powerhouse for partnerships development as a founding entity of AXA Partners. A key enabler for this business transformation will be the IT Operations Tribe in charge of...

  • IT Operations Manager

    hace 3 días

    Barcelona, Barcelona, España AXA Partners A tiempo completo

    Are you looking for a new challenge? In Axa Partners we are looking for our next IT Operations Manager AXA Partners aims at becoming AXA Group preferred networks & Service Company and a powerhouse for partnerships development as a founding entity of AXA Partners. A key enabler for this business transformation will be the IT Operations Tribe in charge of...

  • Applications Engineering Manager

    hace 3 semanas

    Barcelona, España SP Industries A tiempo completo

    **ATS Scientific Products **is searching for an **Applications Engineering Manager (Bilingual Spanish/English) **to join the team! **RESPONSIBILITIES**: - Responsible for detailed review of customer requirements and development of solutions to meet the needs of the customer, maximizing use of standard and existing designs to minimize risk and in line with...

  • Senior Manager Genomics Operations, Translational

    hace 4 semanas

    Barcelona, España AstraZeneca A tiempo completo

    **Senior Manager Genomics Operations, Translational Medicine, Oncology R&D - Barcelona, Spain** At **AstraZeneca**, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge...

  • Hardware Functional Safety Engineer

    hace 4 semanas

    Barcelona, España SOCIAL TEC HUNTING A tiempo completo

    Responsibilities:You will carry out the HW product design to ensure the technical and functional feasibility of the products giving support to the project teams, with the objective of reaching cost, quality and timing goals established by the direction. Qualifications:BS degree in  Electronic, Telecommunications, Computer science, or...

  • Senior Implementation Project Manager

    hace 7 días

    Barcelona, España LittleBig Connection A tiempo completo

    **Who are we?**: **About LittleBig Connection**: The world of work has been transforming at an incredible speed. Today, companies must not only adapt to keep pace with change - they have to get ahead of the game. They need to function as integrated organizations, positioning the best talent at the heart of each project to leverage the right skills at the...