Braveheart Bio · 1 day ago
(Senior) Director, Data Management
United States
Full-time
Remote
Director/Executive
$225K/yr - $286K/yr
8+ years expBraveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. The Senior Director, Data Management is responsible for ensuring the integrity, quality, and timely delivery of all clinical trial data across the cardiovascular portfolio, with a focus on developing and executing data management strategies for late-stage clinical programs.
BiotechnologyLife ScienceTherapeutics
Hiring Manager
Erica Arkin
Responsibilities
Lead the end-to-end clinical data management strategy for Phase 3 and late-stage clinical trials
Set up data management vendors as required, including authoring of RFPs, reviewing and negotiating data management budgets and contracts, and liaising with study management CRO to ensure site training and timely initiation
Provide hands-on oversight of CROs and external data management vendors, ensuring delivery against timelines, quality, and budget
Serve as the primary data management point of contact for internal cross-functional teams including Clinical Operations, Biostatistics, Regulatory, Safety, and Medical Affairs
Oversee development, review, and approval of key data management deliverables including DMPs, CRFs, edit checks, data transfer specifications, overall medical coding strategy and database lock documentation
Ensure high standards for data integrity, quality, and compliance with GCP, regulatory requirements, CDASH, CDISC and inspection readiness expectations
Ensure CRO-executed data management activities support reliable interim reviews, safety monitoring, and final analyses
Coordinate the ongoing data review activities and proactively identify data risks and implement mitigation strategies to support on-time, high-quality study execution
Define and maintain critical data and processes, review and monitor key risk indicators (KRIs) and quality tolerance limits (QTLs)
Partner closely with Biostatistics to support interim analyses, database locks, and final clinical study reports
Support regulatory submissions and responses related to clinical data
Contribute to long-term clinical systems planning and scalability as the organization grows
Establish and maintain data management SOPs, processes, and standards appropriate for a growing late-stage organization
Qualification
Required
Bachelor's degree in life sciences, data sciences, or a related field
At least 8 years of progressive experience in clinical data management within the biotechnology or pharmaceutical industry
Direct experience supporting Phase III clinical trials, including late-stage database locks and regulatory submissions
Strong CRO and vendor oversight experience, with a track record of driving accountability and quality
Hands-on experience with EDC systems, data standards, and clinical data workflows
Demonstrated ability to work cross-functionally in a lean, fast-paced development environment
Strong written and verbal communication skills with a collaborative, team-oriented approach
Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude
Preferred
Advanced degree in a scientific or quantitative discipline
Experience in cardiovascular and/or rare disease clinical development
Experience in SAS, R or Python programming
Prior experience in a small or mid-sized biotech environment transitioning into late-stage development
Exposure to regulatory inspections and health authority interactions related to clinical data
Experience helping build or scale data management functions and infrastructure
Company
Braveheart Bio
Braveheart Bio is a clinical-stage biotechnology company focused on developing precision therapies in the cardiovascular disease space.
2-10 employees
Funding
Current Stage
Early StageTotal Funding
$185M2025-11-05Series A· $185M
Recent News
2026-01-06
2025-12-16
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