Clinical Data Manager

Key Responsibilities

Research Database Build & Full Data Management

• Configure/maintain EDC forms and eCRF specifications as needed to support ingestion and downstream analysis, focusing on scalability and standardization.
• Own end-to-end Data Management for Evidence Generation studies: build, validate, and maintain research databases from ingest → cleaning → QC → data lock.
• Develop and run data cleaning workflows (queries, reconciliation, audit trails), and ensure inspection-ready documentation.

EHR → EDC Auto-Import & Data Model Strategy

• Design and operate data model strategy for automated ingestion of EHR-level RWE into the EDC.
• Work hands-on with APIs/integration endpoints and unify disparate data models (site/EHR variability, mapping logic, versioning, schema evolution).

EHR Systems Fluency / Site Data Reality

• Partner with site IT/informatics and the Product team to understand EHR constraints, extract structures, and change management.
• Translate EHR data realities into feasible study data capture and monitoring plans.

Collateral, SOPs, and Enablement

• Create and maintain DMPs, SAPs, SOPs, runbooks, and training materials that operationalize the above processes across care pathways.

Statistical Analysis, as needed

• Perform statistical analyses on cleaned datasets (descriptive, comparative, time-to-event where appropriate) and support evidence packages and reporting.

Qualifications

Required

• 5–7+ years in clinical research/RWE data management with hands-on database build + cleaning/QC ownership.
• SQL + Python (or R) for data transformation, QC checks, and reproducible pipelines.
• Experience with EHR or EHR-derived datasets and understanding of common structures/coding systems (ICD-10, CPT, LOINC, RxNorm preferred).
• Practical familiarity with API-based ingestion and integrating multiple data sources/models.
• Experience building/owning DMPs/SOPs/runbooks and maintaining audit-ready documentation.
• Familiarity with integrating leading AI techniques into your work product.

Preferred

• Experience with EDC platforms (Medidata Rave, REDCap, Castor, Veeva, etc.).
• CDISC familiarity (SDTM/ADaM) or strong equivalent standardization experience.
• Stats experience in real-world/implementation studies (propensity methods, time-to-event, mixed models).