Senior Manager, Clinical Data Management
About The Position
We are growing our Data & Science team to solve complex real-world problems across multiple therapeutic areas. As our Senior Manager overseeing the Clinical Data group within the Data and Science Department you will work at the intersection of real-world data, clinical context, and methodology with our partners to ensure all available data is being used in the most efficient, data-driven way possible. Based in San Francisco, CA, this is a hybrid role reporting directly to the SVP, Data and Science. Why This Role Matters You will help shape the future of medical research and patient care. Your expertise will guide the transformation of raw clinical data into meaningful insights, accelerating drug development and enhancing medical practices. You will ensure the quality and integrity of our data, forming the foundation for groundbreaking discoveries. What You Get to Do 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
Requirements
- 3+ years working with ophthalmology or urology clinical data
- Significant experience managing a team of contract part-time clinical data abstractors for Real World Data projects
- 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, specifically for Real World Data
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
51-100 employees
