Résumé
About the Role
Key Responsibilities:
Provides DM leadership across assigned trial(s) Acts as the Trial Data Scientist where needed ensuring strong DM representation across the CTT for moderate complexity non-priority trial(s).
Demonstrates a business understanding of the compound(s) profile and data strategy to identify and assist in successful application of data management processes and documentation across assigned trials, i.e, ensuring consistency across data quality plans
Ensures alignment with the TA level data strategy as defined by the TA Data Strategy Director.
Understanding of CDISC or other recognized industry standards and how these impact the programming team.
Provides accelerated feedback to assure well written, stable protocols and amendments. Recognize and resolve protocol issues that may impact database design, data validation and/or analysis/reporting, minimizes the data footprint to focus on the trial endpoints and ensures utilization of available data standards.
Performs DM activities for study start up including preparing the architecture of the eCRF, CCG’s, Data Quality Plan (DQP), Data Quality Plan Module (DQPM), Data Transfer Specification (DTS) and performing user acceptance testing (UAT).
Manage local lab set-up for the Clinical Database as applicable.
Performs DM hands on activities during the course of the study, with a strong emphasis on quality, integrity and on-time delivery.
Essential Requirements:
University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
Fluent English (oral and written).
Ability to work under pressure demonstrating agility through effective and innovative team leadership
Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions and to external stakeholder
Proven ability to interrogate and view data though various programming/GUI techniques
Excellent problem solving skills
Ideally 5+ years’ experience in Drug Development with at least 4 years' in Clinical Data Management
Excellent verbal and written skills
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.
