Job Description Summary

Job Description

Key Responsibilities: -

• As Clinical Data Scientist, provide data management input on Clinical Trial teams. May have the role of Trial Data Scientist on small low complexity trials
• Performs DM activities for startup of a study including preparing the eCRF, CCG’s where needed, Data Quality plan (DQP) Data Quality Plan Module (DQPM) and performing user acceptance testing (UAT) as applicable
• Manage local lab set up for the Clinical Database as applicable. Under supervision ensures consistency of assigned trials with program level standards
• Understands third party data requirements and begins to gather an understanding of new technologies that may be used during clinical trials
• Performs ongoing review of all data generated from the clinical study including Third party and local lab data as well as SAE reconciliation where applicable
• Ensures activities that are performed are done with quality and understanding of the process. Verifies and tracks eCRF completion including Query resolution and provides data status updates as needed. With support from the Trial Data Scientist develops proposals to resolve issues that may occur during the running of assigned trials
• With support from the Trial Data Scientist gives input into Study Specification worksheets should assigned trials need to be outsourced
• Has a working knowledge of FDA and ICH guidelines. Has proven ability to use the tools available to generate listings for data review and where necessary provides these to the study teams. Generates the study status reports for use at Clinical trial team meetings.

Essential Requirements:-

• University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
• Strong technical skills,
• Fluent English verbal and written
• Ideally 3 years’ experience in Drug Development with at least 2 years in Clinical Data Acquisition & Management

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:

We are 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

Skills Desired