Associate Director, Clinical Data Systems and Informatics

Clearnotehealth; San Mateo (CA); On-site; USD 155,000 - 190,000; Full time

Benefits offered by this job

Stock options

Generous benefits

Job summary

Clearnotehealth is looking for an Associate Director, Clinical Data Systems and Informatics based in San Mateo, CA. This role involves the management of clinical data to ensure success in research efforts and clinical trials. Responsibilities include coordinating data delivery into the Data Warehouse, overseeing electronic case report forms, and maintaining data quality. Strong technical expertise and over 7 years in clinical data management are required. The position offers a salary range of $155,000 - $190,000, depending on skills and experience.

Qualifications

• 7+ years of clinical data management experience.
• Hands-on, technically adept, with hybrid CDM role experience.
• Expert understanding of database and Data Warehouse concepts.

Responsibilities

• Coordinate with clinical operations for data delivery into Data Warehouse.
• Maintain data management plans for clinical studies.
• Oversee design and validation of electronic case report forms.

Skills

Clinical data management experience

Technical expertise

SQL knowledge

Software engineering

EDC platforms experience

Good Clinical Practices knowledge

Strong communication skills

Tools

SQL

DBT

Python

Medrio

Job description

Job Title: Associate Director, Clinical Data Systems and Informatics

Location: San Mateo, CA; San Diego, CA

Position 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 is instrumental to the success of our research efforts and clinical trials by managing and organizing clinical data. Data from the systems overseen will be integrated into discovery and clinical research, enabling precise, rigorous scientific decisions that support the development of screening tests.

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 a 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 a 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 authoring, and study administration
• Ability to author CDM‑critical documents such as DMPs, CRF completion guidelines, data validation plans, 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 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

Salary

The anticipated salary range for this position is $155,000 - $190,000. The actual salary will be dependent on experience, knowledge, skills, and abilities.

Benefits

• Generous benefits to all employees, including stock options

EEO Statement

We celebrate diversity in perspectives and backgrounds, and this is reflected in our innovation, our mission, and values. Our differences make us unique, help us innovate, and allow us to persevere. We strive to achieve representation and inclusion and redefine the possibilities for patients living longer lives.