Summary
About the Role
Key Responsibilities:
In collaboration with SSO Clinical Project Manager (CPM), supports recruitment strategies and site performance by ensuring high quality and compliance of monitoring activities.
Is accountable for monitoring quality, timely data entry and issue resolution.
Ensures CRA monitoring competency gaps are identified and resolved through targeted training curricula in collaboration with training group as well as by performing co-monitoring visits with training purposes.
Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times.
Actively manage CRA team performance including implementation of development and performance improvement plans.
Is responsible for execution of annual CRA oversight visit plan to assess ongoing CRA monitoring competency, identifying issues, and developing resolution strategies
Is responsible for the hiring, training, development, and retention of a team of CRAs executing Phase I-IV Global Drug Development (GDD) trials.
Ensures CRAs have the required level of monitoring and disease area knowledge and skills to successfully deliver to protocol requirements
Essential Requirements:
A degree in scientific or health discipline.
Extensive experience in clinical research - planning/executing and/or monitoring clinical trials.
Experience in project management and evidence of team leadership capabilities.
Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution.
Good communication skills, ability to influence others & Relationship management.
Excellent communicator and presenter (oral and written).
Ability to manage sites independently; Proven ability to work independently with minimal supervision
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: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
