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. This role provides professional 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 RoleKey Responsibilities: Provides DM leadership across assigned trial(s) and 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 the successful application of data management processes and documentation across assigned trials, ensuring consistency across data quality plans.Ensures alignment with the TA level data strategy as defined by the TA Data Strategy Director.Understands CDISC or other recognized industry standards and how these impact the programming team.Provides accelerated feedback to assure well-written, stable protocols and amendments. Recognizes and resolves protocol issues that may impact database design, data validation, and/or analysis/reporting, minimizing the data footprint to focus on the trial endpoints and ensuring 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).Manages 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.QualificationsUniversity 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 stakeholders.
Proven ability to interrogate and view data through various programming/GUI techniques.
Excellent problem-solving skills.
Ideally, 5+ years of experience in Drug Development with at least 4 years in Clinical Data Management.
Excellent verbal and written skills.
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