Job Description

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 [Role]! #GCO Job Purpose: The SSO Contracting Specialist is accountable for coordination, preparation, and execution of clinical study contracts (PI, site, institution, MSA, local vendors, etc. as applicable) in a direct country or extended country group (OPC and satellite countries) in close collaboration with SSO Study Start-Up Managers, SSO Clinical Project Managers and SSO Finance Specialists in compliance with Novartis processes, GCP/ICH and regulatory requirements. . Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead and SSO Study Start-Up Managers to ensure SSU timelines and deliverables are met according to country commitments . Accountable for coordination, preparation, and execution of clinical study contracts and amendments (PI, site, institution, MSA, local vendors, etc. as applicable) in assigned projects . Tracks and oversees contract status incl. dispatch and return of contracts . Negotiates financial & legal conditions, escalates issues as applicable . Single point of contact for local Legal and ERC (e.g., for patient reimbursement topics) . Develops and standardizes local contract templates (e.g., for EC submission if required by local regulation) and MSAs . 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. Activities & Interfaces How does this role operate within, interact with and impact the organization . Externally facing role with impact on Principal Investigators and Institution/Site business offices. Diversity & Inclusion / EEO Minimum Requirements Education: . Commercial or medical training (e.g., vocational qualification) or a degree in scientific or health discipline with experience in clinical operations and/or project management Languages: . Fluent in both written and spoken English, local language as needed Experience/Professional requirement: . 1+ years of experience in clinical operations or equivalent . Understanding of clinical drug development with particular emphasis on trial set-up, and contracting Competencies: . Demonstrated ability to problem solve and mediate complex issues . Understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis standards Skills & Knowledge: . Strong interpersonal, negotiation and conflict resolution skills. Independent, dynamic, structured and committed way of working . Communicates effectively in a local/global matrixed environment

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