Associate Director, Clinical Data Management

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.

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

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.

• Bachelor’s degree required; Master’s degree preferred
• 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

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.

Applicants must be authorized to work in the United States.