Feasibility Manager

Band

Level 5

Job Description Summary

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.

 

Job Description

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)

• 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:

• 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

• 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

• Agility to move fast across different therapeutic areas and indications

Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us Learn more here:

You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

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.

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PLEASE NOTE THAT THIS IS A SHORT TERM MISSION WHICH WILL CONCLUDE AT THE END OF 2024.

 

Skills Desired

Budget Management, Clinical Trials, Negotiation Skills, People Management, Process Improvement, Project Management, Project Planning, Vendor Management