Job ID
388304BR
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
Position Title
SSO Feasibility Manager
Role Requirements
Education:
Scientific degree and advanced degree with clinical trial experience and/or project management, is preferable
Languages:
Experience/Professional requirement:
Competencies:
Skills & Knowledge:
Job Type
Full Time
Country
Hungary
Work Location
Budapest
Functional Area
Research & Development
Division
Development
Business Unit
GCO GDD
Employment Type
Regular
Company/Legal Entity
Hungary
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Shift Work
No
Early Talent
No
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