Precision Point Staffing ™ · 16 hours ago
Senior Director of Clinical Data Management
United States
Full-time
Remote
Director/Executive
$235K/yr - $270K/yr
12+ years expPrecision Point Staffing is seeking a Senior Director of Clinical Data Management to provide strategic and operational leadership for all clinical data management activities. The role involves building and overseeing data management infrastructure and ensuring high quality, inspection ready clinical trial data.
Staffing & Recruiting
Hiring Manager
Matthew Hashemi
Responsibilities
Develop and execute the overall clinical data management strategy aligned with corporate and clinical development goals
Build scalable data management infrastructure, systems, standards, and SOPs
Serve as the subject matter expert for data governance, data integrity, and data quality
Lead inspection readiness activities related to clinical data management
Contribute to regulatory submissions including NDA, BLA, and MAA filings
Oversee all data management activities across Phase One through Phase Three trials and registrational programs
Lead database design, build, validation, and lock activities in collaboration with CRO partners or internal teams
Ensure timely and accurate delivery of clean, high quality clinical trial data
Review and approve data management plans, edit check specifications, CRFs, and data transfer agreements
Oversee data cleaning, reconciliation, query management, and external data integration
Ensure compliance with GCP, ICH guidelines, FDA regulations, and applicable global regulatory requirements
Select, oversee, and manage CROs and external data vendors
Establish clear scope, timelines, quality metrics, and budget accountability
Conduct vendor performance reviews and ensure alignment with study objectives
Collaborate closely with biostatistics, clinical operations, medical, regulatory, and pharmacovigilance teams
Qualification
Required
Bachelor degree in Life Sciences, Computer Science, Biostatistics, or related discipline
12-15 plus years of progressive clinical data management experience in biotech, pharma, or CRO environments
Prior experience at the Director or Senior Director level
Demonstrated experience supporting global multi site clinical trials across multiple phases
Strong expertise in EDC systems such as Medidata Rave, Veeva, Oracle, or similar platforms
Deep understanding of CDISC standards including SDTM and ADaM
Proven experience leading database locks and supporting regulatory submissions
Strong knowledge of GCP, ICH, FDA, and global regulatory requirements
Excellent communication, collaboration, and executive presence
Preferred
Advanced degree preferred
Experience building or scaling data management functions in emerging biotech environments is strongly preferred
Company
Precision Point Staffing ™
Precision Point Staffing's team of expert recruiters has a deep understanding of the job market, industry trends, and the skills and experience that employers are looking for in candidates.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Austin Lux
Co-Founder
Matthew Hashemi
Co-Founder
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