Associate Director, Clinical Data Systems and Informatics

ClearNote Health•San Diego, CA

1d•Hybrid

About The Position

ClearNote Health is an early cancer detection company focused on the development and commercialization of non-invasive epigenomic tests to detect cancer through a standard blood draw, earlier than existing methods and when the disease is still treatable. Leveraging its novel liquid biopsy technology, ClearNote Health is initially focused on high-mortality cancers with the greatest need for early detection, starting with pancreatic and ovarian cancers. The Associate Director, Clinical Data Systems and Informatics will contribute to the development of our diagnostic tests through management of clinical data flow into our data warehouse and reporting on that data. This role will be instrumental to the success of our research efforts and our clinical trials with the management and organization clinical data. The data from the systems overseen will be integrated into our discovery and clinical research efforts, enabling precise, rigorous scientific decisions leading to the development of screening tests that meet our team’s high standards.

Requirements

7+ years of clinical data management experience
Hands-on, technically adept
Experience working in hybrid CDM role spanning both hands-on study execution and oversight
Software engineering expertise
Expert understanding of database and DWH concepts
Experience with EDC platforms including eCRF design, edit check authorizing, and study administration
Ability to author CDM-critical documents including DMPs, CRF completion guidelines, data validation plan, and SOPs
Working knowledge of clinical data standards (CDASH/CDISC preferred)
Familiarity with query management workflows and data lock/freeze procedures
Deep expertise in SQL
DBT experience required
Python experience preferred
Strong writing skills and experience documenting your work
In-depth clinical database build knowledge.
Medrio experience preferred.
Working knowledge of Good Clinical Practices, clinical research, clinical trial process and related regulatory requirements
Familiar with cancer related medical classifications and ontologies such as ICD-10
Strong communication skills

Nice To Haves

Python experience preferred
Medrio experience preferred

Responsibilities

Coordinate with clinical operations personnel to ensure data from Electronic Data Capture (EDC) systems is delivered into our Data Warehouse (DWH)
Author and maintain data management plan (DMP) for clinical studies, ensuring alignment with study requirements and ICH E6 (R2) GCP standards
Oversee the design, build, and validation of electronic case report forms (eCRFs), including edit check programming and UAT execution.
Manage data flow from site to EDC, ensuring timely resolution of queries and database integrity.
Develop and maintain data validation plans, including programmatic and manual edit checks to support ALCOA+ data quality principles
Lead the creation of data review listings and metrics reports to support ongoing data cleaning and study oversight
Coordinate with CRO or external CDM vendors on data management deliverables, timelines, and quality standards
Support database lock activities including final data reconciliation, discrepancy resolution, and lock documentation
Maintain TMF-relevant CDM documentation in accordance with regulatory inspection readiness standards
Coordinate with clinical operations personnel to ensure data from non-EDC sources (e.g. ad hoc spreadsheets) is delivered into our DWH
Transform clinical data in the DWH into forms suitable for use by the entire research and development team
Own the accuracy and integrity of all clinical data in the DWH
Serve as an SME on DWH clinical data for the research and development team
Coordinate with our Regulatory/QA team to ensure clinical data flow and the DWH are compliant with procedural and regulatory requirements
Define methods and metrics for assessing data quality; monitor and maintain data quality
Integrate clinical data with other corporate data
Provide project status updates to cross-functional team members.
Provide technical guidance and training in the use of clinical data in the DWH