Associate Director, Clinical Data Systems and Informatics

Key Responsibilities

• Cook up with clinical operations personnel to ensure data from Electronic Data Capture (EDC) systems is delivered into our Data Warehouse (DWH)
• Write and keep a data management plan (DMP) for clinical studies, making sure it matches study requirements and ICH E6 (R2) GCP standards
• Oversee the design, construction, and validation of electronic case report forms (eCRFs), including edit check coding and UAT execution
• Manage data flow from site to EDC, making sure timely resolution of queries and database integrity
• Create 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
• Handle database lock activities including final data reconciliation, discrepancy resolution, and lock documentation
• Keep TMF-relevant CDM documentation in line with regulatory inspection readiness standards
• Cook up 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
• Act as an SME on DWH clinical data for the research and development team
• Cook up 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

Requirements

• Seven plus 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 write 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

Qualifications

• Master's degree in a relevant field (e.g., Biostatistics, Computer Science, Bioinformatics)
• Ph.D. in a relevant field (e.g., Biostatistics, Computer Science, Bioinformatics)

Skills

• SQL
• Python

Benefits

ClearNote Health provides generous benefits to all employees including stock options. We are building a world-class company, based in San Diego and San Mateo.

Pay

TBD

Schedule

TBD