Vignetic
Senior Manager, Clinical Trial Analytics & Visualization New Jersey, NJ
Title: Senior Manager, Clinical Trial Analytics & Visualization
Job Type: Permanent
Primary Location: New Jersey
The Challenge:
Our client is seeking an experienced candidate within Analytics & Visualization. In this role, you will be responsible for growing and maintaining the portfolio of applications and visualizations supporting clinical trial oversight and conduct activities across clinical development functional areas. Facilitation of new requirements and management of daily operations of the business applications in the visualization platform. This includes full utilization of your skill set as internal consultant, application developer, and project manager specialized in the various configurations and processes supporting analysis and reporting needs within our clinical trial portfolio.
You have experience in assessing and implementing ICH GCP requirements into business processes driving sponsor oversight and risk based monitoring activities, helping the team ensure value creation via fit for purpose visualizations and dataflow. You will be subject matter expert in the visualization needs, the underlying business processes the data sources, and relevant integrations with source systems (e.g., EDC, CTMS, ePRO, IRT, CDISC, Safety, QMS, TMF, Project Mgmt., data facilitated by a variety of 3rd parties).
You have both consultancy experience and development/programming experience in visualization tools (preferably Qlik), but not limited to. You are an expert in assessing how to best fulfill business requirements and facilitating data review and analysis via interactive solutions and traditional outputs. You constantly think out of the box and internal customer in mind to ensure solutions are fit for purpose and deliver high business value.
As a Senior Manager, Clinical Trial Analytics & Visualization, you will be part of the Clinical Trial Analytics & Visualization team and responsible for leading planning and execution of assigned applications/processes/projects (as applicable) within own area. You will have high influence on the global application roll out, set-up and processes and will report to the Associate Director, Team Lead, Clinical Trial Analytics & Visualizations.
Role and Responsibilities:
- Facilitate business requirements, collect needs, assess and propose a way forward, including prototyping and Proof of Concept efforts
- Manage and lead Application Developer roles and resources within the area of responsibility in the application portfolio, in the development and implementation of standard and customized solutions
- Data modelling and design of back end (ETL) and front-end (UI) layers
- Project manage application roll out across trials including planning, development, validation, and implementation activities
- Engage with super users and maximize user adoption and streamline requirements as well as underlying business processes
- Design, coordinate, and execute training activities
- Ensure consistent and quality implementation and use of the visualization platform across trials
- Keep oversight of end-to-end dataflow, feeding into and reporting out of the applications, incl. oversight and execution of troubleshooting needs and outcomes
- Ensure applications are kept in validated state. Lead periodic reviews, issue management, patch (risk) assessment, etc.
- Collaborate with IT to ensure system (IT platform) is kept in a validated state and living to the expectations of the visualization work (upgrades configurations, functionality, add-ons)
- Optimize development model for application and visualization delivery (stack of SOPs, WIs and associated material)
Essential skills and requirements:
- Extensive experience and in depth understanding of clinical and operational data managed within a clinical trial context, data flow, and clinical data review and reporting requirements
- Savvy in visualization functionality, best practices and improvement opportunities
- Clinical and Operational databases capturing clinical trial data
- Insights, interfaces and reports facilitating data review and analysis
- Understanding of scientifically driven and operationally driven needs
- Trial planning and conduct processes and steps / levels
- Visualization and report development and configuration (what can source systems do out of the box, what is best managed by a BI/visualization platform, etc.)
- Relational data models and programming for visualization and reporting purpose
- Data interchange and data integrity (standards, methods, technology)
- CDISC standards
- Strong communication skills, for intense an agile communication with cross functional stakeholders as well as technical experts
- Holistic understanding of the overall dataflow, data review and decision-making outputs in clinical trials, and the capability to extend that into complex oncology trials, with a variety of data and constant tailoring into new situations and needs
- Adaptability for changing needs and handling a series of parallel tasks and discussions.
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