Overview
Skills
Job Details
An innovative early-stage biotech company developing next-generation oncology therapies is seeking a Director of Clinical Data Management to build and lead its data function from the ground up. Reporting to the VP of Clinical Operations, this role offers a rare opportunity to shape data strategy, systems, and infrastructure in a fast-moving environment.
Key Responsibilities:
Build and scale the CDM function across internal staff and vendors
Lead all data activities for early and late-phase oncology trials
Develop standards and processes for CRFs, edit checks, DMPs, data validation, and UAT
Oversee EDC systems, ePRO, IRT, and external data integrations
Ensure compliance with ICH, CDISC, 21 CFR Part 11, Google Cloud Platform, and GDPR
Collaborate closely with Clinical Operations, Biometrics, and external CROs
Drive quality and consistency in data review, reporting, and visualization
Core Requirements:
15+ years in clinical data management, with deep oncology experience
Hands-on leadership in early-stage or growing biotech environments
Strong expertise with EDC systems (e.g., Rave, Medrio, Inform)
Proven experience with CDISC/CDASH standards and data visualization tools (e.g., Spotfire, Tableau)
Technical fluency with SQL and working knowledge of SAS, R, or Python
Familiarity with biomarker and exploratory data types a plus
Bachelor's degree in a scientific or technical field; CCDM preferred
This is a high-impact, visible role where your expertise will directly shape the company's clinical data infrastructure and influence critical decisions across the portfolio.
If you're excited to build from scratch, wear multiple hats, and help drive oncology innovation at an early-stage biotech, apply today.
Confidential conversations welcome.