Job Description Summary
Location: East Hanover, NJ
Onsite
Hiring for multiple roles.
About the role:
Love clinical data management? Bring that passion to Novartis!
This key Senior Principal Clinical Data Scientist will be responsible and accountable for managing all Data Management deliverables at a consistently high standard with respect to cost, quality, and timelines for all assigned indications within one or more Global Clinical Program(s)/Project(s).
Your Key Responsibilities:
- Provides DM leadership across assigned trial(s) and Program(s) ensuring strong DM representation across the CTT. Acts as an ambassador for CDAM across the organization, showcasing business value and benefits.
- Demonstrates a business understanding of the compound profile and data strategy to identify and assist in successful application of consistent data management processes and documentation across assigned programs, i.e. ensuring consistency across data quality plans.
- 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. Ensures consistency of program level standards.
- Maintains awareness of the status of start-up, conduct and finalization activities for all trials within assigned program(s). Tracks and requests necessary resources. Ensures the key study risks & issues are shared in the Project Review Meeting led by Sr GHs/GHs.
- Provides accelerated feedback to assure well written, stable protocols and amendments. Recognize and resolve protocol issues that may impact database.
Essential Requirements:
- Bachelor's degree in life science, computer science, pharmacy, nursing or closely related discipline.
- 7 years' experience in Drug Development with at least 5+ years' in Clinical Data Management.
- Demonstrated strong leadership, collaboration and organizational skills with proven ability to successfully manage simultaneous trials and meet deadlines.
- Excellent understanding of clinical trials methodology, GCP and medical terminology.
- Proven ability to interrogate and view data through various programming/GUI techniques.
- Must be able to anticipate challenges and risks and proactively suggest/implement solutions.
- 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 stakeholders.
- Understanding of project management concepts in order to aid delivery across a program.
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!
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally.
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives.
Salary Range: The pay range for this position at commencement of employment is expected to be: between $130,000 - $195,000; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period.
Skills Desired: Clinical Data Management, Data Architecture, Data Governance, Data Integration, Data Management, Data Profiling, Data Quality, Data Science, Data Strategy, Master Data, Waterfall Project Management.
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