Associate Director, Clinical Data Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Spearhead the establishment of data management processes and their implementation across Character’s clinical trials as the inaugural dedicated Data Management professional.

• Supervise external Data Management vendors and CROs, ensuring they meet deliverables, timelines, and maintain data quality.

• Manage Data Management Plans that outline data flow, responsibilities, timelines, and quality criteria for each study.

• Collaborate with internal stakeholders to ensure data collection aligns with study design and analytical requirements.

• Direct the design, construction, and testing (UAT) of eCRF and databases within the EDC system.

• Create specifications for edit checks and establish data validation rules.

• Lead data cleaning initiatives, which include query management, external data reconciliation, and medical coding.

• Oversee database lock processes, encompassing SAE reconciliation and final data review in coordination with Biostatistics.

• Ensure compliance with GCP, 21 CFR Part 11, and relevant data privacy regulations.

• Keep data management documentation ready for inspection.

• Develop scalable systems and standards to support Character’s expanding clinical pipeline.

⛳️ Requirements

• A Bachelor’s degree is mandatory.

• 5–7+ years of experience in Clinical Data Management across various trial phases.

• Preferably, experience in ophthalmology or retina.

• Practical experience with EDC platforms (e.g., Medidata Rave, Veeva Vault CDMS, or similar), including database construction, edit check specification, and UAT.

• Comprehensive understanding of data cleaning processes, such as query management, external data reconciliation (labs, imaging, ePRO/eCOA), and medical coding (MedDRA/WHODrug).

• Proven experience in independently managing external Data Management vendors and CROs, including scope, timelines, and quality supervision.

• Familiarity with GCP, 21 CFR Part 11, and clinical data standards (e.g., CDISC/CDASH) as they pertain to data management.

• Demonstrated capability to develop processes and systems from the ground up in a dynamic, fast-paced environment.

• High integrity, sound judgment, and the ability to operate autonomously as Character’s inaugural Data Management professional.

• Applicants must possess authorization to work in the United States.

🏝️ Benefits

• Equity

• Medical insurance

• Dental insurance

• Vision insurance

• 401(k)

• Accrued paid time off policy

• Competitive salary

• Strong equity incentives