Global Clinical Operations - Feasibility Manager

Key responsibilities:

• 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.

Essential requirements:

• Scientific degree and advanced degree with clinical trial experience and/or project management, is preferable
• Fluent in both written and spoken English
• 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
• Strong project management capabilities

Desirable requirements:

• Agility to move fast across different therapeutic areas and indications
• 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
• Demonstrated negotiation and conflict resolution skills both internal and external (site relationships)
• Communicates effectively in a local/global matrixed environment

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