Manager, Clinical Data Innovation

Job not on LinkedIn

🔥 3 minutes ago

🏄 California, Pennsylvania – Remote

🏄 California – Remote 🔔 Pennsylvania – Remote

💵 $124k - $186k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Jazz Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative medicines that address serious unmet medical needs. With a strong commitment to research and development, Jazz focuses on creating life-changing therapies, emphasizing the importance of collaboration, diversity, and employee engagement in its operations. The company prides itself on transforming patients' lives through its meaningful product offerings and a culture that fosters enthusiasm and flexibility.

📋 Description

• Lead implementation of new processes and technologies used to review and trend 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 • Advise cross-functional clinical trial working groups on using the clinical data platform to achieve objectives in data review, medical monitoring, and risk management plans • Contribute to development of software systems and related infrastructure for efficient, user-friendly clinical study data displays and metrics reports • Collaborate with external vendors and data managers to automate acquisition of clinical data into the platform • Disseminate application-usage best practices and implement solutions to improve adoption and effectiveness of the clinical data platform • Identify and implement continuous improvement initiatives for Clinical Data Innovation team processes • Program QlikSense visualizations providing visibility into clinical trial start-up and conduct • Configure and program centralized data-monitoring methods supporting risk-based quality management • Support continued development and software updates of the clinical data platform and ensure deliverables meet system user requirements and GxP requirements

🎯 Requirements

• Bachelor's 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 • 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 communicating technical concepts to non-technical individuals and business requirements to technical programmers • Strong problem-solving skills with an emphasis on clinical data and technical/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, including ICH E6, Regulatory Guidelines, and SDLC • Experience with elluminate platform is a plus • Experience with advanced analytics, including 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 is a plus • Experience supporting or performing centralized statistical monitoring is a plus

🏖️ Benefits

• Discretionary annual cash bonus or incentive compensation • Discretionary equity grants • Medical insurance • Dental insurance • Vision insurance • 401k retirement savings plan • Flexible paid vacation

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