Head of Clinical Data Management

PicnicHealth is revolutionizing how life sciences companies advance medicine while providing immediate value to the patients who power the research. Through direct patient engagement, state of the art machine learning, and scientific expertise, PicnicHealth uniquely curates 100% of consenting patients’ medical records to generate the high quality and clinically-rich evidence that life sciences companies need, at a fraction of the cost of traditional study models. At the same time, we give patients immediate access to their medical records through a patient portal that simplifies participation and drives engagement.  To date we’ve helped tens of thousands of patients securely access their records and proactively contribute to advancing research in diseases that impact their lives. 

Founded in 2014, PicnicHealth partners with 12 of the top 20 biopharma companies and has raised over $100 million in venture capital from investors including Amplify Partners, Felicis Ventures and B Capital Group.

If you are looking to join an award winning, mission-driven, motivated team that is making a real impact across millions of people’s lives, PicnicHealth might just be the place for you. 

The Opportunity

As the Head of Clinical Data Management you will oversee and provide hands-on support for the execution of clinical data management activities across our growing pipeline of digital observational studies leveraging innovative AI and emerging technologies. In this role, you will be responsible for all aspects of research study data management at PicnicHealth such as data accrual, data curation, and quality assurance- ensuring data integrity, compliance, and usability for research purposes. You’ll lead a team of clinical and operational experts within our data management function and collaborate closely with cross-functional teams during study execution. This role is crucial in advancing our mission to improve patient outcomes through efficient, high-quality data management.

As the Head of Clinical Data Management you will be responsible for:

• Clinical Data Management Strategy 
• Developing and implementing clinical data management strategies aligned with PicnicHealth's goals and clinical research best practices, including feedback into clinical data management system development and optimization as well as study data collection, reviewing, and reporting 
• 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
• Study-Specific Data Management
• Developing and implementing study-specific data management and data quality plans and supporting documentation (data transfer specifications, data review/reconciliation plans, database lock plans, etc.) as required across the data lifecycle for various data sources (e.g., primary data from participant surveys, secondary data curation from electronic health records, digital radiology imaging, external data like medical claims)
• 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 (e.g., GCP, FDA, GDPR)
• 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 based on study data models designed in coordination with internal experts and the customer 
• 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 
• Cross-functional Collaboration
• Collaborating seamlessly with internal teams, including Epidemiology, Clinicians, Biostatistics, Project Management, and Patient Recruitment, Enrollment, & Engagement, to ensure successful study execution 
• 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 (e.g., privacy, legal) to maintain compliance with relevant regulations and reporting/disclosure expectations and to stay informed of evolving standards
• Team Leadership
• Directly manage clinical and operational team members (3-4 team members) within the data management function 
• Collaborating closely with data management teams at our Philippines site, ensuring seamless execution of data management plans across all PicnicHealth teams 
• Fostering a culture of innovation and continuous improvement in clinical data management practices

You are a great fit if you:

• 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, as well as traditional clinical data management systems and/or electronic data capture (EDC) platforms
• 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 
• Familiarity with CDISC standards (SDTM, ADaM, CDASH) is a plus 
• Familiarity with emerging technologies in clinical research, including AI/ML applications is a plus 
• Excellent project management, communication, and problem-solving skills
• Passion for PicnicHealth's mission to accelerate medical research through innovative data management

We expect all team members to be motivated to be amazing in their roles and, ultimately, to move the PicnicHealth mission forward.

Perks & Benefits @PicnicHealth   

At PicnicHealth you get to solve real problems with real solutions, great tech, and great people. We look to attract and retain exceptional performers through a mission that matters, a culture that allows team members to do their best work and be their real selves, and through competitive compensation and benefits packages aligned to the market and our Core Values.

We’re a remote first company, with teammates spread across the US. We support in-person gatherings, including co-working spaces and multi-day onsites,  to build connections and move forward strategic initiatives. Expect to travel 2-4 times a year.  For our team members in the Bay Area, who prefer to work in person we can offer a hybrid set up to work from the SF office on a flexible schedule.

Target Base Salary Range: $170K - $210K

The base salary PicnicHealth offers may vary depending upon the scope, complexity, and autonomy of the position and on the candidate’s job-related knowledge, skills, and experience. The total package will include equity, in addition to a full range of medical and/or other benefits, depending on the position offered. Pay and benefits are subject to change at any time, consistent with the terms of any applicable compensation or benefit plans. 

You also get:

• 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

Equal Opportunity Statement

PicnicHealth is committed to promoting an inclusive work environment free of discrimination and harassment. We value a diverse and balanced team where everyone can belong.