Senior Clinical Data Scientist

We are seeking a Senior Clinical Data Scientist to assist/lead in the timely and professional management of clinical trial data 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.This role reports to the Director Data Management.

About the Role

Key Responsibilities:

Provides DM leadership across assigned trial(s) Acts as the Trial Data Scientist where needed ensuring strong DM representation across the CTT for moderate complexity non-priority trial(s).

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.

Understanding of 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 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.

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

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

Ideally 5+ years’ experience in Drug Development with at least 4 years' in Clinical Data Management

Excellent verbal and written skills

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Division Development

Business Unit Innovative Medicines

Location Ireland

Site Dublin (Novartis Corporate Center (NOCC))

Company / Legal Entity IE02 (FCRS = IE002) Novartis Ireland Ltd

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

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