Manager, Clinical Data Innovation

Jazz Pharmaceuticals • Philadelphia, PA

2d • Remote

About The Position

The Manager, Clinical Data Innovation works within the GCDO Business & Technology Capabilities department and is responsible for implementing clinical studies on Jazz’s centralized clinical data platform and supporting its adoption by study teams. The role helps teams use the platform to achieve oversight, medical monitoring, clinical data review, and risk-based quality management objectives. It calls for a creative, curious problem-solver motivated to transform clinical trial execution through practical applications of data and technology that increase automation, efficiency, and quality.

As a subject matter expert on the clinical data platform, the Manager implements new studies and advises clinical trial working groups on using interactive data listings and analytics to improve trial start-up and conduct. The role also contributes to departmental and cross-functional initiatives to assess and implement technologies that innovate and transform clinical trial execution. Depending on the work, the position may also program visualizations using QlikSense, configure centralized monitoring methods, and support ongoing platform development and compliance with system user requirements and GxP requirements.

Requirements

• Bachelor's or master's degree in Biology, Mathematics, Computer Science, or a related field.
• 3–5+ years of relevant work experience, such as clinical trial execution and/or clinical systems implementation.
• In-depth knowledge of clinical trial planning, start-up, and conduct concepts and challenges that can be supported using data visualizations.
• Excellent verbal and written communication skills, including communicating technical concepts to non-technical individuals and business requirements to technical programmers.
• Strong problem-solving skills, particularly with clinical data and technical and data problems.
• Experience eliciting and documenting requirements for dashboards, reports, or data review listings using agile methodologies or principles.
• Ability to prioritize and handle multiple tasks simultaneously in a cross-functional team environment.
• In-depth understanding of regulatory, industry (GCP), and technology standards and requirements, including ICH E6, regulatory guidelines, and SDLC.

Nice To Haves

• Experience with the elluminate platform.
• Experience applying advanced analytics, including machine learning methods, to clinical trials.
• Experience with T-SQL, QlikSense, R, or Python.
• Knowledge of ICH E6 (R2) Risk-Based Quality Management.
• Experience supporting or performing centralized statistical monitoring.

Responsibilities

• Lead implementation of new processes and technologies for reviewing and trending clinical trial data during study conduct.
• Lead end-to-end implementation of clinical studies on the clinical data platform, including vendor RFP review, data imports, user acceptance testing, and delivery of standard and custom listings and visualizations.
• Build relationships with cross-functional clinical trial working groups and advise them on using the platform to meet objectives in functional plans, such as data review, medical monitoring, and risk management plans.
• Contribute to the development of software systems and related infrastructure for efficient, user-friendly displays of clinical study data and metrics reports.
• Collaborate with external vendors and data managers to automate acquisition of clinical data into the platform.
• Promote best practices for application use and identify and implement solutions that support comprehensive platform adoption and effectiveness.
• Identify and implement continuous improvement initiatives for Clinical Data Innovation team processes.
• As applicable, program QlikSense visualizations that provide visibility into clinical trial start-up and conduct.
• As applicable, configure and program centralized data-monitoring methods to support risk-based quality management.
• As applicable, support clinical data platform development and software updates, ensuring deliverables meet system user requirements and GxP requirements.

Benefits

• Potential eligibility for a discretionary annual cash bonus or incentive compensation, depending on the role and plan terms.
• Potential eligibility for discretionary equity grants under the company's Long Term Equity Incentive Plan.
• Medical insurance.
• Dental insurance.
• Vision insurance.
• 401(k) retirement savings plan.
• Flexible paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager