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 Senior Principal Clinical Data Scientist is 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). Coaches, provides leadership and enhances capability across CDAM ensuring consistency across assigned program(s) . Provide pro-active and effective communication to DMLT, Global Program teams and other stakeholder groups. Ensure consistently high quality data (in alignment with the Novartis Clinical Data Quality Statement) available for analysis and reporting.
Your responsibilities include, but are not limited to:
- 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. Proficient 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 design, data validation, program standards and/or analysis/reporting, minimizes the data footprint to focus on the trial endpoints
- Manages effective escalation of issues in order to keep stakeholders appraised of DM activities and proposed resolutions. Supervises and drives the overall DM timelines across assigned programs. Reviews the Data Management Metrics on the assigned Program.
- Coaches and mentors associates as required, ensures that DM associates on the program are aware of the risks, priorities, goals and impact of the work contribution. Develops risk management strategies to prevent data quality issues from derailing projects
- Act as subject matter expert (SME) or, as assigned, lead process improvement/non-clinical project initiatives. Ensures adherence to ICH GCP, DM standards, SOPs/WPS and process guidelines. Responsible for quality control and audit readiness of all assigned data management deliverables and Programs
- Provide adequate quality oversight to important tasks and activities. Ensures all errors at any stage are assessed for systematic impact.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What you’ll bring to the role:
Required Experience & Qualifications:
- Ideally 8 years’ experience in Drug Development with at least 5+ years' in Clinical Data Management
- Excellent verbal and written skills University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree. 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 influence and communicate across functions and to external stakeholders
- Understanding of project management concepts in order to aid delivery across a program
Desirable Experience & Qualifications:
- University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
- Excellent interpersonal skills and proven ability to operate effectively in a global environment.