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Manager, Clinical Data Innovation
Jazz Pharmaceuticals. Lead implementation of new processes and technologies used to review and trend clinical trial data during study conduct .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial execution and implementation of clinical data platforms, with a strong focus on data visualization, regulatory compliance, and cross-functional collaboration. Proficient in programming visualizations and configuring data-monitoring methods to enhance clinical study efficiency and effectiveness.
Highest-signal resume keywords
Clinical Trial ExecutionData VisualizationRegulatory Compliance (GCP, ICH E6)QlikSense ProgrammingRequirements Elicitation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Trial PlanningData Review ListingsAgile MethodologiesT-SQLRPythonMachine Learning MethodsCentralized Statistical MonitoringSoftware Development Life Cycle (SDLC)Risk-Based Quality Management
Soft Skills
Excellent Communication SkillsProblem-Solving SkillsAbility to Prioritize TasksCross-Functional Team Collaboration
Tools & Technologies
Elluminate PlatformClinical Data PlatformQlikSense
Industry Keywords
Good Clinical Practice (GCP)Regulatory GuidelinesClinical Data InnovationClinical Study MetricsContinuous Improvement Initiatives
Tech Stack
Tools & technologiesGoogle Cloud PlatformPythonSDLCSQL
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Discretionary annual cash bonus or incentive compensation
- Discretionary equity grants
- Medical insurance
- Dental insurance
- Vision insurance
- 401k retirement savings plan
- Flexible paid vacation