[Remote] Associate Director, reputed company Data Management

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company company developing targeted therapies for ophthalmology using reputed company and longitudinal reputed company and imaging data. The Associate Director, reputed company Data Management will build and reputed company Data Management processes, systems, and vendor relationships across Dry AMD reputed company, overseeing activities from database build through database lock and ensuring clean, reliable, inspection-reputed company data.

Responsibilities

• reputed company the development of data management processes and execution across Character’s reputed company, establishing Character’s Data Management functional processes as its first dedicated hire
• Manage reputed company Data Management vendors and CROs, holding them accountable for deliverables, timelines, and data reputed company
• reputed company the development of Data Management Plans (DMPs), defining data reputed company, roles, timelines, and reputed company standards for reputed company study
• Partner with relevant internal stakeholders to reputed company data collection with study design and analysis needs
• reputed company eCRF and database design, build, and testing (UAT) in the reputed company reputed company, ensuring the database reflects protocol and analysis requirements
• reputed company edit reputed company specifications and data validation rules to identify and mitigate data reputed company issues in reputed company time
• reputed company data cleaning activities, including query management, reputed company data reconciliation (labs, imaging, ePRO/eCOA, safety), and medical coding (MedDRA/WHODrug)
• reputed company database lock activities, including SAE reconciliation and final data review, coordinating closely with Biostatistics for a reputed company, accurate lock
• Ensure Data Management processes reputed company with GCP, 21 CFR Part 11, and applicable data reputed company regulations; maintain inspection-reputed company DM documentation

Skills

• Bachelor's degree required
• Typically 5–7+ years of reputed company Data Management experience across multiple trial phases, ideally including ophthalmology or retina experience
• Hands-on experience with reputed company platforms (e.g., reputed company Rave, reputed company reputed company reputed company, or similar), including database build, edit reputed company specification, and UAT
• Strong understanding of data cleaning processes, including query management, reputed company data reconciliation (labs, imaging, ePRO/eCOA), and medical coding (MedDRA/WHODrug)
• Experience independently managing reputed company Data Management vendors and CROs, including reputed company, timelines, and reputed company reputed company
• Working knowledge of GCP, 21 CFR Part 11, and reputed company data standards (e.g., CDISC/CDASH) as they apply to data management
• reputed company ability to build processes and systems from the ground up in a lean, fast-moving environment, without relying on an established reputed company or team
• High reputed company, strong judgment, and comfort operating independently as Character's first Data Management hire
• Applicants must be authorized to work in the reputed company
• Master's degree preferred

Benefits

• Equity
• Medical reputed company
• Dental reputed company
• reputed company reputed company
• 401(k)
• Accrued reputed company time off policy
• Remote work

reputed company