Job Description Summary

Job Description

Key Responsibilities: -

• Provides DM leadership across assigned trial(s) Acts as the Trial Data Scientist where needed ensuring strong DM representation across the CTT.
• 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.
• Ensures alignment with the TA level data strategy as defined by the TA Data Strategy Director. Competent in relevant 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.
• Performs DM activities for study start up including preparing the architecture and performing user acceptance testing (UAT).Manage local lab data flow and 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.
• Disseminates study level information to the Clinical Trial Team (CTT) and Program Clinical Data Scientist (PCDS). Supports and assists Junior staff for assigned trials
• Ensures Third party and other necessary reconciliation activities are performed for the study in a timely manner. Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence
• Tracks and reports status and progress for assigned trials, indications or programs. Ensures adherence to ICH GCP, DM standards, SOPs/WPS and process guidelines.

Essential Requirements:-

• Timing and quality of database locks affecting submissions to regulatory authorities.
• University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
• 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, verbal and written skills
• Ideally 5 years’ experience in Drug Development with at least 4 years' in Clinical Data 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