Sso Feasibility Manager

hace 2 semanas

Barcelona, 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

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