Job Title: Associate Director,Clinical Data Systems and Informatics Location: San Mateo, CA; San Diego, CAPosition Summary: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.
Key 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
Qualifications:- 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
The anticipated salary range for this position is $155,000 - $190,000. The actual salary will be dependent on various factors that may include experience level, knowledge, skills and abilities.
