cdisc jobs in San Diego

This role owns clinical trial data monitoring, analysis, and reporting for a venture-backed medical device startup pursuing FDA approval. You will ramp up on existing SQL, Python, TypeScript, and Terraform pipelines to build and extend clinical monitoring dashboards, define data quality checks, produce safety and efficacy analyses, and support regulatory submissions.…See more The position requires 5+ years of clinical analytics or biostatistics experience, strong SQL and cloud data warehouse skills (BigQuery or equivalent), proficiency in Python or R, and deep familiarity with clinical trial methodology, EDC systems, and regulated documentation practices.

Senior Data Engineer role owning end-to-end data architecture for a medical device startup preparing for FDA submission. Responsibilities span defining instrumentation specs and data models upstream, designing and maintaining transformation pipelines on Google Cloud and BigQuery, implementing warehouse schemas with regulatory traceability, building EDC and device data integrations, and producing CDISC-compliant datasets (SDTM/ADaM) for clinical submissions.…See more Requires 7+ years of production data systems experience, strong Python and SQL, cloud platform expertise, and the ability to translate clinical, regulatory, and operational requirements into data infrastructure.

Director-level role leading clinical data management across multiple development programs at a therapeutic company. Responsible for overseeing data management CROs and vendors, ensuring data quality and regulatory compliance, managing the clinical data lifecycle (database build, data review, reconciliation, lock), and leading cross-functional teams.…See more Requires 10+ years of clinical data management experience, deep knowledge of FDA/EMA/ICH-GCP requirements, CDISC standards, EDC systems, and demonstrated ability to manage complex global trials.

Lead Clinical Data Manager responsible for directing data management activities across the full lifecycle of one or more clinical studies, from database setup through lock and close-out. The role includes managing CRO and EDC vendor performance, authoring core data management documentation (DMP, DRP, guidelines), ensuring compliance with FDA regulations, ICH-GCP, and CDISC standards (CDASH, SDTM), and representing Data Management on cross-functional teams.…See more Requires 7–10+ years of clinical data management experience with demonstrated expertise in EDC systems (Medidata Rave preferred), vendor oversight, FDA/ICH/HIPAA regulations, and oncology knowledge including RECIST/RANO criteria.

Principal Specialist overseeing clinical data management for pharmaceutical studies, responsible for database lock coordination, CRO performance monitoring, and ensuring quality control and audit procedures meet departmental standards. The role requires running data review listings, coding medical history and adverse event data using MedDRA, coding concomitant medications using WHO Drug dictionaries, and collaborating with database programmers to ensure CDISC/SDTM compliance.…See more Requires 8+ years of pharma industry experience (or equivalent with advanced degree), strong knowledge of Good Clinical Data Management Practices, and demonstrated ability to lead and manage teams across multiple projects.

Sr. Principal Specialist will oversee clinical database programming operations, including review/cleaning programs, validation procedures, database migrations, SAS dataset creation, and vendor management within a pharmaceutical environment.…See more The role requires hands-on technical expertise in Medidata Rave, SAS, and SQL alongside strategic leadership of cross-functional teams and oversight of regulatory compliance, inspection readiness, and system implementations. Responsibilities include proactive risk mitigation, evaluation and adoption of new technologies, and acting as a technical liaison across Clinical Data Management, Clinical Operations, Regulatory, and IT. The ideal candidate combines 8+ years of clinical database programming experience (or equivalent with advanced degree) with expert knowledge of CDISC standards, GCP regulations, and end-to-end drug development processes.

Clinical Data Engineer II/III will develop and maintain data transformation models across clinical schemas, ensuring data quality, reliability, and regulatory compliance in a healthcare environment. The role requires designing data contracts, building reconciliation logic to unify multi-source data, and owning clinical result data end-to-end from ingestion through monitoring.…See more You will partner with clinical operations, regulatory, and research teams to resolve data issues, maintain dashboards subject to formal validation, and serve as a subject-matter expert on the warehouse clinical data. This position demands 5+ years of hands-on data engineering with production transformation frameworks (dbt preferred), deep SQL expertise, and demonstrated experience in regulated environments.

The Clinical Data Manager will oversee clinical data management activities for assigned studies, ensuring compliance with protocols, industry standards, and FDA regulations. Responsibilities include managing CRO data management counterparts, developing and maintaining Electronic Data Capture (EDC), Interactive Response Technology (IRT), and Electronic Patient-Reported Outcomes (ePRO) systems, designing Case Report Forms (CRFs), establishing data review strategies, and coordinating data transfers.…See more The role requires collaboration across Clinical Operations, Clinical Safety, Biostatistics, and external vendors, with a focus on timely database lock and risk identification. Candidates need a bachelor's degree in a medical or scientific field, minimum 2 years of clinical data management experience, proficiency with Microsoft Office Suite, and knowledge of CDISC standards, ICH guidelines, 21 CFR Part 11, and FDA guidelines.