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
Using advanced data management tools and techniques, provide professional and lean execution of Data Management products and milestones with respect to cost, quality and timelines for all assigned trials within Clinical Data Acquisition and Management. Ensure consistently high-quality data delivery (in alignment with the Novartis Clinical Data Quality Statement) to analysis and reporting.
Your responsibilities include, but are not limited to:
Commitment to Diversity & Inclusion:
- 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, 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.
- Provides accelerated feedback to assure well written, stable protocols and amendments. 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.
- Performs DM activities for study start up including preparing the architecture of the eCRF, CCG’s, Data Quality Plan (DQP), Data Quality Plan Module (DQPM), Data Transfer Specification (DTS) 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. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks). Ensures adherence to ICH GCP, DM standards, SOPs/WPS and process guidelines
Novartis is 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 4 years’ experience in Drug Development with at least 3 years' in Clinical Data Management
- Fluent English (oral and written).
- 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
- Excellent verbal and written skills
Desirable Experience & Qualifications:
- University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
Global Drug DevelopmentBusiness Unit
Novartis Ireland LimitedFunctional Area
Research & DevelopmentJob Type
Full TimeEmployment Type