Director Data Management

Pedestal Health (formerly Target RWE) combines deep health system partnerships, longitudinal data curation at scale, and modern study design to build continuous, high-quality evidence for life sciences organizations. The Director, Data Management leads Pedestal Health's clinical data management (CDM) function across prospective studies, clinical trials, external control arms, and registry cohorts. This is a hands-on leadership role responsible for the design and build of study databases, the standards that govern data collection, medical coding, and the delivery of analysis-ready, submission-grade datasets.

Responsibilities

Lead the design, build, configuration, and validation of Electronic Data Capture (EDC) databases; Own database specifications, edit checks, dynamics, derivations, and user-acceptance testing; Manage study startup, mid-study amendments, and database migrations; Oversee integration of external and non-CRF data sources into the study database; Author and maintain CRF/eCRF design guidelines and reusable standard forms; Partner with clinical, biostatistics, and medical teams to translate protocols into data collection instruments; Establish and govern data management standards, conventions, and SOPs; Oversee medical coding of adverse events, medical history, and concomitant medications; Ensure coding accuracy, consistency, and timeliness; Own the strategy and quality of CDISC-conformant deliverables; Direct the creation and review of SDTM datasets, annotated CRFs, define.xml, and Study Data Reviewer's Guide; Run Pinnacle 21 conformance checks and resolve findings; Own end-to-end data cleaning, query management, discrepancy and SAE reconciliation, and database lock activities; Define and monitor data quality metrics, dashboards, and KPIs; Ensure compliance with ICH-GCP, 21 CFR Part 11, FDA/EMA regulations; Build, mentor, and manage a team of clinical data managers, programmers, and coders; Manage CRO and technology vendors; Contribute to proposals, timelines, and budgets; Serve as SME and thought leader

Requirements

Bachelor's degree in life sciences, health informatics, computer science, or a related field; 10+ years of clinical data management experience, including 3+ years leading or managing teams; Demonstrated hands-on expertise building and validating EDC databases (Medidata Rave, Veeva, Oracle, or similar); Proficiency with CDISC standards - CDASH, SDTM, and ADaM - and submission deliverables; Experience overseeing medical coding with MedDRA and WHODrug; Strong working knowledge of ICH-GCP, 21 CFR Part 11, and FDA/EMA regulatory requirements; Proven ability to manage CROs and vendors, budgets, and multiple concurrent studies to deadline

Nice to have

Society for Clinical Data Management (SCDM) certification (CCDM) or equivalent; Experience with real-world evidence, registries, external control arms, or EHR-derived data; Familiarity with Pinnacle 21, SAS, and/or data-review programming; Therapeutic-area experience in hepatology, dermatology, or gastroenterology

Benefits

Hybrid work arrangement; Comprehensive health, dental, and vision coverage; 401(k) with company match; Generous PTO and paid parental leave