[Hiring] Associate Director, Clinical Data Management @Character Biosciences

Role Description

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
  • 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.
  • Manage external Data Management vendors and CROs, holding them accountable for deliverables, timelines, and data quality.
  • Oversee the development of Data Management Plans (DMPs), defining data flow, roles, timelines, and quality standards for each study.
  • Partner with relevant internal stakeholders to align data collection with study design and analysis needs.
• Database Build, Data Cleaning & Quality
  • Lead eCRF and database design, build, and testing (UAT) in the EDC system, ensuring the database reflects protocol and analysis requirements.
  • Develop edit check specifications and data validation rules to identify and mitigate data quality issues in real time.
  • Drive data cleaning activities, including query management, external data reconciliation (labs, imaging, ePRO/eCOA, safety), and medical coding (MedDRA/WHODrug).
  • Lead database lock activities, including SAE reconciliation and final data review, coordinating closely with Biostatistics for a timely, accurate lock.
  • Ensure Data Management processes comply with GCP, 21 CFR Part 11, and applicable data privacy regulations; maintain inspection-ready DM documentation.

Qualifications

• 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.

Benefits

• 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.