Manager, Clinical Data Innovation

Jazz Pharmaceuticals, Inc.; California; Remote; USD 140,000 - 190,000; Full time

Job summary

Jazz Pharmaceuticals, Inc. is seeking a Manager, Clinical Data Innovation to lead implementation of our centralized clinical data platform across studies in California.

You will drive adoption, oversee data reviews, and develop dashboards that support medical monitoring and risk-based quality management. You will partner with cross-functional trial teams to translate business needs into actionable analytics, mentor junior staff, and explore new technologies to automate and enhance trial

Qualifications

• Experience in clinical trial planning and conduct using data visualizations.
• Experience with dashboards and data review listings.
• Familiarity with regulatory and GxP standards (ICH E6).
• Experience eliciting and documenting requirements for dashboards using Agile.

Responsibilities

• Lead the implementation of new processes and technologies used to review and trend clinical trial data during study conduct.
• Lead the 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.
• Develops strong relationships with cross functional clinical trial working group to advise on platform use for data review plans, medical monitoring, and risk management.
• Contribute to the development of software systems and infrastructure to generate displays of clinical study data and metrics reports.
• Collaborate with external vendors and data managers to automate acquisition of all clinical data into the platform.
• Cultivate knowledge of best practices, facilitating adoption and effectiveness of the clinical data platform.
• Identify and implement continuous improvement initiatives for Clinical Data Innovation team processes.
• Program visualizations for start-up and conduct using QlikSense; configure centralized monitoring for risk-based quality management.
• Support the ongoing development of the platform, including software updates and adherence to user requirements and GxP.

Skills

Clinical trial data

Data visualization

Communication skills

Problem solving

Agile methodologies

Requirements elicitation

Cross-functional collaboration

Education

Bachelor's or Master's Degree in Biology, Mathematics, Computer Science or related fields

Tools

QlikSense

T-SQL

R

Python

Job description

The Manager, Clinical Data Innovation within the GCDO Business & Technology Capabilities department is responsible for the implementation of clinical studies on Jazz’s centralized clinical data platform and adoption of the platform by study teams to achieve oversight, medical monitoring, clinical data review, and risk-based quality management objectives. We are looking for a creative, curious individual who thrives on problem solving and is motivated by the goal of transforming clinical trial execution through practical applications of data and technology to increase automation, efficiency, and quality. S/he will be a subject matter expert on the clinical data platform, responsible for implementation of new studies and acting as an advisor to clinical trial working groups on using the interactive data listings and analytics to continuously improve clinical trial start-up and conduct. S/he will also participate on departmental and cross-functional initiatives to assess and implement new technologies to innovate and transform clinical trial execution.

Essential Functions/Responsibilities

• Lead the implementation of new processes and technologies used to review and trend clinical trial data during study conduct
• Lead the end-to-end implementation of clinical studies on the clinical data platform, including vendor RFP review, data imports, user accepting testing, and delivery of standard and custom listings and visualizations
• Develops strong relationships with the cross functional clinical trial working group team to proactively advise on how to use the clinical data platform to achieve objectives defined in functional plans such as data review plans, medical monitoring plans, and/or risk management plans
• Contribute to the development of software systems and related infrastructure to generate displays of clinical study data and metrics reports that are efficient and user-friendly
• Collaborate with external vendors and data managers to automate the acquisition of all clinical data into the platform
• Cultivate and disseminate knowledge of application-usage best practices, identifying and implementing solutions to facilitate comprehensive adoption and effectiveness of the clinical data platform
• Identify and implement continuous improvement initiatives for Clinical Data Innovation team processes

May additionally perform the following functions:

• Program visualizations that provide visibility into start-up and conduct of clinical trials using QlikSense
• Configure and program methods for centralized monitoring of data to support risk-based quality management

• Support the continued development of the clinical data platform, including software updates, and ensure that deliverables adhere to system user requirements and GxP requirements

Required Knowledge, Skills, and Abilities

• 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, specifically in communicating technical concepts to non-technical individuals and communicating business requirements to technical programmers
• Strong problem-solving skills with an emphasis on clinical data
• Strong problem-solving skills with an emphasis on solving technical and data problems
• Experience with requirements elicitation and documentation for dashboards, reports, or data review listings using agile methodologies/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 [ICH E6 and Regulatory Guidelines and SDLC
• Experience with elluminate platform is a plus
• Experience with advanced analytics (machine learning methods) applied to clinical trials is a plus
• Experience with T-SQL, QlikSense, R, or Python is a plus
• Knowledge of ICH E6 (R2) Risk Based Quality Management a plus
• Experience supporting or performing centralized statistical monitoring a plus
• Jazz values are Passion, Innovation, Collaboration and Integrity and Pursuit of Excellence! This is highly valued in our employees.

Required/Preferred Education and Licenses

• Bachelor or Master's Degree in Biology, Mathematics, Computer Science or related fields
• 3-5+ years of relevant work experience, such as clinical trial execution and/or clinical systems implementation.

#LI-DM1

#LI-Remote