369935BR
Apr 02, 2024
Ireland

About the Role

100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine – imagine the impact you could have as [Role]! #GCO

The Principal Data Scientist is responsible and accountable for managing all Data Management activities using advanced data management tool and techniques with respect to cost, quality and timelines for all assigned projects/trials within a Clinical Program. The position is a key collaborator and strategic partner with stakeholders ensuring that data management activities for the clinical trials are executed efficiently with timely and high quality deliverables (in alignment with the Novartis Clinical Data Quality Statement). Provide active and effective communication to Clinical Trial Teams and other stakeholder groups

Your responsibilities include, but are not limited to:

• Lead data management activities as Trial Clinical Data Scientist for several studies or as a Program Clinical Data Scientist for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization.
• Co-ordinate activities of Data Scientist either internally or externally. Make data management decisions and propose strategies at study or project level. Ensures alignment with the TA level data strategy as defined by the TA Data Strategy Director
• Provides accelerated feedback to assure well written, stable protocols and amendments aligned with Program standards and requirements. 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.
• Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical data management aspects (timelines, scope, resource plan), e.g. as Clinical Data Acquisition & Management representative in study- or project-level team.
• Review eCRF, assess the need for additional study specific CRF, discuss data structures and review activities and ensure project-level standardization which allows pooling.
• Provide and implement data management solutions; ensure knowledge sharing. Act as data management expert in problem-solving aspects.

• Responsible for quality control and audit readiness of all assigned data management deliverables as well as accuracy and reliability of the clinical database. Act as subject matter expert (SME) or, as assigned, lead process improvement/non-clinical project initiatives
• Maintain up-to-date advanced knowledge of programming software used for creating reports or visualizations as well as industry requirements (e.g. CDISC /SDTM/ADaM). Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Role Requirements

What you’ll bring to the role:

Required Experience & Qualifications:

• Ideally 7+ years' in Clinical Data Management supporting clinical trials
• Fluent English (oral and written).
• 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. Ability to transfer own knowledge to others. Experience as a Trial Data Scientist for several studies and some work performed at a project level
• Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions and to external stakeholders

Desirable Experience & Qualifications:

• University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.

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

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Development
GCO GDD
Ireland
Dublin
Research & Development
Full Time
Regular
No
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369935BR

2/2 Principal Clinical Data Scientist (Trial Data Manager/Project Data

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