Senior Manager, Clinical Data Management

Summary

Join Verana Health's Data & Science team as a Senior Manager, Clinical Data Management. You will lead a team, develop standard operating procedures for clinical data abstraction, collaborate with cross-functional teams, and ensure data quality and integrity for real-world evidence generation. This hybrid role involves overseeing informatics, developing software platforms, designing data entry forms, and implementing quality control plans. You will contribute to Verana's regulatory strategy and work on commercial projects. Your expertise will shape the future of medical research and patient care, transforming raw clinical data into meaningful insights. Verana Health offers a comprehensive benefits package.

Requirements

• 3+ years working with ophthalmology or urology clinical data
• Experience managing a team of contract PT clinical data abstractors
• Partnership with team members from medical, product, technology, and quantitative sciences teams
• Experience with clinical and research applications of real-world data sources, including clinical data from unstructured EHR sources and administrative claims data
• Knowledge of regulatory requirements for use cases for real-world data applications, with a focus on the expected documentation of steps and processes used to curate and transform raw EHR data into standardized, structured data elements
• Adept in project management, prioritization, and stakeholder management
• Education: Bachelor's degree in science, nursing, or healthcare-related field
• Data Abstraction: Mastery of manual data abstraction techniques and tools
• Data Analysis: Interpret complex clinical data and find meaningful insights
• Communication: Able to present complex information to diverse audiences
• Technical Proficiency: Expertise with data management software, statistical analysis tools, and healthcare IT systems
• Continuous Learning: Commitment to staying at the forefront of clinical data management, real-world evidence, and regulatory guidelines

Responsibilities

• Develop and implement standard operating procedures for training clinical data abstractors, abstracting clinical data from unstructured EHR data, and entering interpreted data
• Collaborate with clinical and data teams to create manual abstraction guidelines
• Build an accomplished clinical data abstraction team
• Oversee informatics in supporting Verana's multiple product offerings
• Work with product and technology teams to develop, test, deploy, and scale a functional software platform for clinical data abstraction activities
• Design standardized data entry forms, instructions, and logic check rules for real-time error flagging
• Implement a rigorous quality control and assurance plan for all clinical data abstraction activities to meet regulatory requirements
• Collaborate with medical teams on analytic plans for commercial projects and internal scientific activities
• Contribute to Verana's regulatory strategy, focusing on use cases for curated datasets across therapeutic areas

Benefits

• 100% health, vision, and dental coverage
• 401K match
• Flexible vacation plans
• Annual stipend for learning and wellness
• Access to wellness apps like Headspace