[Hiring] Manager, Clinical Data Innovation @Jazz Pharmaceuticals

Role 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.

Qualifications

• 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

Requirements

• 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

Benefits

• Medical, dental, and vision insurance
• 401k retirement savings plan
• Flexible paid vacation
• Discretionary annual cash bonus or incentive compensation
• Discretionary equity grants in accordance with Jazz’s Long Term Equity Incentive Plan