Note: The job is a remote job and is open to candidates in USA. Character Biosciences is a precision medicine company developing targeted therapies for ophthalmology using genomics and longitudinal clinical and imaging data. The Associate Director, Clinical Data Management will build and lead Data Management processes, systems, and vendor relationships across Dry AMD clinical trials, overseeing activities from database build through database lock and ensuring clean, reliable, inspection-ready data.
Responsibilities
- 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
- 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
Skills
- Bachelor's degree required
- 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
- Applicants must be authorized to work in the United States
- Master's degree preferred
Benefits
- Equity
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- Accrued paid time off policy
- Remote work
Company Overview