Director Data Management

Pedestal Health

2d•Hybrid

About The Position

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 company partners with pharmaceutical and biotech companies, providers and payers to generate rigorous, multimodal evidence that supports clinical, regulatory and strategic decision-making across the full lifecycle of care. Pedestal Health is committed to advancing medical decision making to improve outcomes for patients. Pedestal Health is a Highlander Health company. Learn more at pedestalhealth.com. The Role The Director, Data Management leads Pedestal Health's clinical data management (CDM) function across our 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. The Director owns data quality, timelines, and regulatory compliance from study startup through database lock, and builds the people, processes, SOPs, and technology that let the function scale.

Requirements

Bachelor's degree in life sciences, health informatics, computer science, or a related field (advanced degree a plus).
10+ years of clinical data management experience, including 3+ years leading or managing teams, in a pharma, biotech, CRO, or RWE setting.
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 (define.xml, annotated CRF, reviewer's guides).
Experience overseeing medical coding with MedDRA and WHODrug, whether in-house or via a coding vendor.
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 Haves

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.

Responsibilities

Lead the design, build, configuration, and validation of Electronic Data Capture (EDC) databases (e.g., Medidata Rave, Veeva Vault CDMS, Oracle Clinical/InForm) across the study portfolio.
Own database specifications, edit checks, dynamics, derivations, and user-acceptance testing (UAT); ensure builds are validated and audit-ready prior to go-live.
Manage study startup, mid-study amendments, and database migrations with minimal disruption to sites and ongoing data flow.
Oversee integration of external and non-CRF data sources (labs, ePRO/eCOA, imaging, biomarkers, EHR-derived data) into the study database.
Author and maintain CRF/eCRF design guidelines, CRF Completion Guidelines, and a library of reusable standard forms aligned to CDISC CDASH.
Partner with clinical, biostatistics, and medical teams to translate protocols into efficient, high-quality data collection instruments.
Establish and govern data management standards, conventions, and SOPs to drive consistency and reusability across studies.
Oversee medical coding of adverse events, medical history, and concomitant medications using MedDRA and WHODrug.
Either lead coding in-house or manage and oversee a coding vendor - defining coding conventions, reviewing auto-encoding and manual review, resolving queries, and ensuring dictionary version control and supervising.
Ensure coding accuracy, consistency, and timeliness, and reconcile coded terms with safety and clinical review.
Own the strategy and quality of CDISC-conformant deliverables, ensuring source data map cleanly to SDTM and support downstream ADaM datasets for statistical analysis and submission.
Direct the creation and review of SDTM datasets, annotated CRFs, define.xml, and the Study Data Reviewer's Guide (SDRG/cSDRG), and coordinate ADaM specifications with biostatistics/programming.
Run Pinnacle 21 (or equivalent) conformance checks and resolve findings to ensure FDA/EMA submission-readiness.
Own end-to-end data cleaning, query management, discrepancy and SAE reconciliation, and database lock activities - delivering clean, on-time data.
Define and monitor data quality metrics, dashboards, and KPIs; report status and risks to study teams and leadership.
Ensure all activities comply with ICH-GCP, 21 CFR Part 11, applicable FDA/EMA regulations, and internal SOPs; support audits and inspections.
Build, mentor, and manage a team of clinical data managers, programmers, and coders; set standards, allocate resources, and develop talent.
Manage CRO and technology vendors - scope, budgets, timelines, oversight, and quality - for outsourced data management and coding.
Contribute to proposals, timelines, and budgets, and represent data management with sponsors and partners.
Serve as SME and thought leader both inside and outside the organization.