Responsibilities
Systems Development and Management
- Maintain and grow a strong working knowledge of the various systems used across CDDA in clinical trials
- Partner across functions and geographies to build and/or refine systems used in operational reporting and analytics
- Resolve system issues quickly to ensure continued access to needed operational information; apply root cause analysis as needed
- Ensure high stakeholder satisfaction through consistent delivery of high quality, timely and insightful outputs throughout analytics value chain
- Develop expertise of processes and data used by business functions
- Apply knowledge and experience and understand and respond to customer feedback on reports and dashboards to continuously improve product functionality and efficiency in how clinical operational insights are gathered, integrated, and delivered, including through automation
- Maintain appropriate change control documentation
- Develop and support user training as needed, including maintenance of job aids, FAQs, knowledge articles, etc
- Partner effectively with vendor staff as needed
- Support system testing as needed
Analytics and Insights
- Using deep understanding of the clinical development process and systems, develop and provide useful operational reports, metrics, and analytics to CDDA users
- Follow appropriate business processes for integration of data and presentation of analytics
- Serve as a technical resource for reporting and analytics
- Identify project risks and issues, and raise concerns appropriately
- Develop improved mechanisms to consolidate, share, identify, and/or report on trends and issues in clinical operational data
- Seek out opportunities to better meet user needs through new or improved analytics delivery or systems
- Generate engaging visual outputs for effective communication, understanding, and decision making by a diverse customer group
Basic Requirements
- Bachelor’s degree in technical science, computer science, engineering, statistics, or related field
- Applied experience in developing and delivering analytic insights (data wrangling, data modeling, data mining, metrics, reporting, and visualizations)
- Expertise with data analysis / visualization applications, languages, and analytics solutions, for example, Power BI, PowerApp, Excel, R, RShiny, AWS, etc., SQL, DAX queries
Additional Skills/Preferences
- Advanced degree
- Experience working with clinical data in a pharmaceutical, biotech, CRO, or Regulatory agency
- Knowledge of regulatory and quality requirements governing clinical development
- Familiarity with systems used in clinical trials like Planisware, Impact, Oracle, Veeva suite, etc
- Experience with Agile Development
- Familiarity with AWS ecosystem
- Experience in Predictive and prescriptive analytics
- Experience in delivering under tight timelines
- Demonstrated proactive process improvement
- Demonstrated project management skills
- High learning agility
- Strong written and verbal communication skills
- Excellent collaboration and teamwork skills
- Strong business acumen