Associate Director, Clinical Data Management

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $179k - $210k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Character Biosciences

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2019

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

🔥 Funding within the last year

💰 $17M Series B - Character Biosciences on 2025-09

Healthcare • Consulting • Biotechnology

Character Biosciences is a precision medicine biotechnology company focused on understanding and treating progressive polygenic eye diseases, with an initial emphasis on age-related macular degeneration (AMD) and primary open-angle glaucoma (POAG). The company integrates large human genomic datasets with longitudinal clinical data, retinal imaging, and AI-enabled biomarker quantification to identify genetic drivers of disease progression and to guide targeted drug discovery and development. Character Biosciences partners with healthcare providers, patients, and industry collaborators to translate genomic and machine-learning insights into more effective, subtype-targeted ophthalmology therapies.

📋 Description

• Lead the development of data management processes and execution across Character’s clinical trials as the first dedicated Data Management hire • Manage external Data Management vendors and CROs, holding them accountable for deliverables, timelines, and data quality • Oversee Data Management Plans defining data flow, roles, timelines, and quality standards for each study • Partner with internal stakeholders to align data collection with study design and analysis needs • Lead eCRF and database design, build, and testing (UAT) in the EDC system • Develop edit check specifications and data validation rules • Drive data cleaning activities, including query management, external data reconciliation, and medical coding • Lead database lock activities, including SAE reconciliation and final data review, coordinating with Biostatistics • Ensure processes comply with GCP, 21 CFR Part 11, and applicable data privacy regulations • Maintain inspection-ready Data Management documentation • Build scalable systems and standards for Character’s growing clinical pipeline

🎯 Requirements

• Bachelor’s degree required • 5–7+ years of Clinical Data Management experience across multiple trial phases • Ideally, experience in ophthalmology or retina • Hands-on experience with EDC platforms (e.g., Medidata Rave, Veeva Vault CDMS, or similar), including database build, edit check specification, and UAT • Strong understanding of data cleaning processes, including query management, external data reconciliation (labs, imaging, ePRO/eCOA), and medical coding (MedDRA/WHODrug) • Experience independently managing external Data Management vendors and CROs, including scope, timelines, and quality oversight • Working knowledge of GCP, 21 CFR Part 11, and clinical data standards (e.g., CDISC/CDASH) as they apply to data management • Proven ability to build processes and systems from the ground up in a lean, fast-moving environment • High integrity, strong judgment, and comfort operating independently as Character’s first Data Management hire • Applicants must be authorized to work in the United States

🏖️ Benefits

• Equity • Medical insurance • Dental insurance • Vision insurance • 401(k) • Accrued paid time off policy • Competitive salary • Strong equity incentives