About the Role

　　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 collaborators 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.

　　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 applying internal and external data (e.g. historical data, individual knowledge within local Study & Site Team and relevant medical/clinical functions, internal and external databases)

　　Leads 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 driven 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.

　　#gco

　　Diversity & Inclusion / EEO

　　We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

　　Role Requirements

　　Education:

　　Scientific degree and advanced degree with clinical trial experience and/or project management, is preferable

　　Languages:

　　• Fluent in both written and spoken English

　　Experience/Professional requirement:

　　• Minimum 5 years' experience clinical development experience in pharmaceutical industry

　　• Capable of leading in a matrix environment, without direct reports and working cross-border

　　• Ability to manage a study from the medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex-clinical / medical / operational issues

　　• Agility to move fast across different therapeutic areas and indications

　　Competencies:

　　• Strong project management capabilities

　　• Demonstrates a knowledge of how to adequately review and read a protocol to understand specifics of study design and answer questions regarding the trial

　　• Applies a detailed understanding of the drug in question to provide medical context as it relates to disease processes, populations, and standards of care

　　• Ability to assess the feasibility of implementing the protocol based on regional medical practice and sound understanding of the overall clinical development plan

　　Skills & Knowledge:

　　• Demonstrated negotiation and conflict resolution skills both internal and external (site relationships)

　　• Communicates effectively in a local/global matrixed environment

　　Division

　　Development

　　Business Unit

　　GCO GDD

　　Location

　　Hungary

　　Site

　　Budapest

　　Company / Legal Entity

　　Hungary

　　Functional Area

　　Research & Development

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No