Senior Clinical Data Manager

Location: Malvern, Pennsylvania, United States; office-based and in person, with limited remote work

Company

hirify.global discovers, develops, and commercializes gene and cell therapies and vaccines for retinal, orthopedic, and infectious diseases.

What you will do

• Lead clinical data management activities across studies and development programs, ensuring consistency, quality, and timely delivery.
• Develop and oversee data management plans, electronic case report forms, database designs, data transfer specifications, and data review plans.
• Develop and validate edit checks, validation reports, and risk-based data management strategies.
• Ensure accurate electronic clinical data collection, documentation completeness, inspection readiness, and audit preparedness.
• Collaborate with Clinical Operations, Biometrics, Biostatistics, Programming, Regulatory, and Quality teams on protocols, data standards, and deliverables.
• Mentor junior data management staff, guide vendors, and lead process improvements and special projects.

Requirements

• Bachelor's degree in clinical, biological, mathematical, or related sciences, a nursing qualification, or equivalent experience.
• 5–7 years of clinical data management experience in a biopharma or CRO environment.
• Experience with clinical trials, CRFs, EDC database development, IRT systems, and diary applications.
• Strong knowledge of GCP, ICH, FDA, and CDISC requirements for clinical studies.
• Strong attention to detail, organization, communication, collaboration, issue resolution, and timeline management skills.
• Ability to work in the office in person; remote work is limited.

Nice to have

• Experience with Veeva.

Culture & Benefits

• Cross-functional collaboration across clinical development, biometrics, regulatory, programming, and quality functions.
• Opportunity to contribute to gene therapy, cell therapy, and vaccine development programs.
• Work is primarily conducted in an office setting during standard working hours, with occasional availability required for priority business needs.