Remote Associate Director, Clinical Data Management

Character Bio; Northern (KY); Hybrid; USD 179,000 - 210,000; Full time

Benefits offered by this job

Equity

Benefits

Job summary

Character Biosciences is seeking an experienced Associate Director, Data Management to build and lead the Data Management function for the Dry AMD program. Remote work within the United States is available as the company scales data operations from the ground up.

You will own end-to-end data lifecycle activities from database design to lock, partnering with cross-functional teams and external vendors to ensure clean, auditable data across trials.

Qualifications

• Typically 5–7+ years of Clinical Data Management experience across multiple trial phases, ophthalmology/retina experience preferred.
• Hands-on experience with EDC platforms (Medidata Rave, Veeva Vault CDMS), including database design, edit checks, and UAT.
• Experience independently managing external Data Management vendors and CROs.
• Knowledge of GCP, 21 CFR Part 11, and CDISC/CDASH data standards.
• Ability to build processes and systems in a lean, fast-moving environment.
• High integrity and independence as Character’s first Data Management hire.

Responsibilities

• Data Management Strategy: develop DM processes and execution across trials as the first dedicated DM hire.
• Vendor Oversight: manage external DM vendors and CROs with accountability for deliverables and data quality.
• Data Management Plans: oversee DMPs with data flow, roles, timelines, and quality standards.
• Cross-Functional Partnership: align data collection with study design and analysis needs.
• Database Build, Data Cleaning & Quality: lead eCRF/database design, edit checks, data cleaning, and SAE reconciliation.
• Database Lock: coordinate lock activities with Biostatistics for timely, accurate lock.
• Compliance: ensure DM processes comply with GCP, 21 CFR Part 11, and data privacy regulations.

Skills

Clinical Data Management

Data quality & cleaning

Vendor management

GCP & 21 CFR Part 11

Tools

Medidata Rave

Veeva Vault CDMS

EDC systems

Job description

Character Biosciences is seeking an experienced Associate Director, Data Management to build and lead the Data Management function for the Dry AMD program. Remote work within the United States is available as the company scales data operations from the ground up.

You will own end-to-end data lifecycle activities from database design to lock, partnering with cross-functional teams and external vendors to ensure clean, auditable data across trials.