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

Associate Director, Clinical Data Management

About Character Biosciences

Character Biosciences is a precision medicine company pioneering targeted therapies for ophthalmology. Our patient data platform integrates genomics with deep, longitudinal clinical and imaging data, enabling us to uncover genetic drivers of disease progression, advance novel therapeutics, and define patient stratification strategies that improve clinical success.

Our interdisciplinary team spans human genetics, clinical science, data science and engineering, and drug discovery and development. We are advancing two programs for Dry Age-related Macular Degeneration (AMD) into the clinic, with additional discovery-stage programs underway.

Founded in 2018, Character has raised capital from leading investors at the intersection of healthcare and technology, including an oversubscribed $110+ million Series B in 2025 co-led by aMoon and Luma Group, with participation from Bausch + Lomb, Innovation Endeavors, Sanofi Ventures, Catalio Capital Management, S32, KdT Ventures, and Jefferson Life Sciences. We also maintain a multi-target drug discovery collaboration with Bausch + Lomb to develop innovative precision medicines for AMD.

Role : Associate Director, Data Management

Reports to: Aggie Malloy

Department: Clinical Research

Team: Development Operations

Level: 8

Location : Remote

About Character Biosciences

The Opportunity

We’re looking for an experienced, independent-minded Associate Director, Data Management to build and lead Character’s Data Management activities and processes from the ground up. As Character’s first Data Management hire, you’ll lead the design and stand up the processes, systems, and vendor relationships that ensure clean, reliable, inspection-ready data across our Dry AMD clinical trials — from database build through database lock. You’ll partner closely with the relevant cross-functional stakeholders to ensure the data underlying our clinical evidence is accurate, complete, and audit ready. This is a foundational role: the systems and standards you put in place will define how Character manages data as our pipeline and organization grow.

You’ll operate with a high degree of independence, including oversight of external DM vendors and CROs — without a built-out internal team to lean on initially.

Responsibilities

Data Management Strategy & Vendor Oversight

• Data Management Strategy: Lead the development of data management processes and execution across Character’s clinical trials, establishing Character’s Data Management functional processes as its first dedicated hire
• Vendor Oversight: Manage external Data Management vendors and CROs, holding them accountable for deliverables, timelines, and data quality
• Data Management Plans: Oversee the development of Data Management Plans (DMPs), defining data flow, roles, timelines, and quality standards for each study
• Cross-Functional Partnership: Partner with relevant internal stakeholders to align data collection with study design and analysis needs

Database Build, Data Cleaning & Quality

• Database Build: Lead eCRF and database design, build, and testing (UAT) in the EDC system, ensuring the database reflects protocol and analysis requirements
• Edit Checks & Validation: Develop edit check specifications and data validation rules to identify and mitigate data quality issues in real time
• Data Cleaning: Drive data cleaning activities, including query management, external data reconciliation (labs, imaging, ePRO/eCOA, safety), and medical coding (MedDRA/WHODrug)
• Database Lock: Lead database lock activities, including SAE reconciliation and final data review, coordinating closely with Biostatistics for a timely, accurate lock
• Compliance: Ensure Data Management processes comply with GCP, 21 CFR Part 11, and applicable data privacy regulations; maintain inspection-ready DM documentation

About You

You are a hands-on, independent-minded data management professional who’s ready to build Character’s Data Management processes from scratch. You’re comfortable owning the full data lifecycle — from database design through lock — and confident making sound decisions without an established playbook or a large internal team to rely on. You bring rigor and structure to ambiguous situations, translating study protocols into clean, reliable databases and processes that hold up to scrutiny.

You are detail-oriented and quality-focused, but you also think about scale: the processes you build today need to work as Character’s pipeline grows. You partner effectively with the relevant cross-functional stakeholders, and you know how to hold external vendors accountable for high-quality deliverables. Like us, you value integrity, individual accountability, team camaraderie, open communication, and a commitment to continuous learning and operational excellence.

• Typically 5–7+ years of Clinical Data Management experience across multiple trial phases, ideally including ophthalmology or retina experience
• 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, without relying on an established playbook or team
• High integrity, strong judgment, and comfort operating independently as Character’s first Data Management hire

The annual pay range for this full-time position is $179,000-$210,000 + equity + benefits. Actual compensation packages are based on a wide array of factors unique to each candidate including but not limited to skill set, years and depth of experience, certifications and work location.

Benefits include a competitive salary, strong equity incentives, medical, dental, vision, 401(k), and an accrued paid time off policy. Character is committed to recruiting, developing, and supporting colleagues from all backgrounds. We embrace diversity, equity, and inclusion as an integral part of our culture.

EEO Statement

Character Biosciences is an equal opportunity employer and is committed to building a diverse and inclusive workforce. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status.

Work Authorization

Applicants must be authorized to work in the United States.