Head of Clinical Data Management

Summary

Join PicnicHealth, a mission-driven company revolutionizing life sciences by providing immediate value to patients through direct engagement, machine learning, and scientific expertise. As the Head of Clinical Data Management, you will oversee clinical data management activities across digital observational studies, leading a team of experts and collaborating with cross-functional teams.

Requirements

• Bachelor's degree in a clinical or life sciences discipline, or related field; advanced degree preferred
• Certified Clinical Data Manager (CCDM) certification is a plus
• 7+ years of experience in clinical data management for clinical trials, with at least 3 years in a leadership role managing direct reports
• Experience in developing, implementing, and overseeing data management plans and quality plans for multiple concurrent observational research studies
• Experience working with real-world data and/or non-traditional data sources (eg, electronic health records, medical claims, participant reported data, medical imaging), curation (eg, chart abstraction, large language models), and transformation (eg, mapping real-world data to CDISC formats)
• Experience in development of database specifications and build, CRF design, and CRF guideline design
• Deep understanding of observational research and strategic knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management processes
• Flexibility and adaptability; you’re energized by the idea of building net-new processes from the ground up and regular iteration based on learnings from customers

Responsibilities

• Developing and implementing clinical data management strategies aligned with PicnicHealth's goals and clinical research best practices
• Continuously improving data management processes and workflows to increase efficiency, data quality, and team productivity
• Establishing clinical data standards and processes to ensure consistency and quality across all observational research studies
• Developing and maintaining standard operating procedures (SOPs), templates, and timelines to support operational models
• Developing and implementing study-specific data management and data quality plans and supporting documentation
• Serving as a data management subject matter expert (SME) for customers, including peer-to-peer interaction with partner/sponsor data management team(s)
• Ensuring study-specific data management practices align with applicable regulatory requirements
• Overseeing the end-to-end data lifecycle across every study, including medical record retrieval requirements, development of CRFs and CRF guidelines, database setup, data curation, and quality assurance and data validation efforts
• Leading data review, including query management, and activities required for interim and final database locks, ensuring high quality for every customer delivery
• Developing operational data management plans across all studies to ensure on-time delivery of all study data
• Collaborating seamlessly with internal teams, including Epidemiology, Clinicians, Biostatistics, Project Management, and Patient Recruitment, Enrollment, & Engagement
• Work closely with the Product, Engineering, and Design Team to leverage, build, and optimize innovative tools that enhance data capture and integrity
• Advise Sales and Solutions teams on data management-related considerations for potential research studies
• Collaborating with Quality & Regulatory and other internal/external experts to maintain compliance with relevant regulations and reporting/disclosure expectations

Benefits

• Comprehensive benefits including above market Health, Dental, Vision
• Family friendly environment
• Flexible time off
• 401k plan
• Free PicnicHealth account
• Equipment and internet funds for home office set up
• Wellness Stipend