Senior Clinical Trial Manager

Location: Malvern, Pennsylvania, United States. Office-based work when not traveling; domestic and international travel may be required.

Company

hirify.global develops gene and cell therapies and vaccines, including treatments for retinal and orthopedic diseases and vaccine research programs.

What you will do

• Lead the planning, execution, and delivery of clinical trials from initiation through close-out.
• Drive study timelines, enrollment execution, operational milestones, and risk mitigation.
• Lead study start-up activities, including site feasibility, investigator selection, vendor coordination, regulatory package readiness, and site activation.
• Manage CRO and vendor performance, governance discussions, deliverables, timelines, and issue resolution.
• Oversee eTMF completeness, essential document filing, quality control, audit readiness, and inspection readiness.
• Coordinate with Clinical Development, Program Management, Biometrics, Regulatory, QA, Finance, investigators, and study physicians.

Requirements

• Bachelor’s degree in life sciences or a related field.
• 7–10 years of clinical research experience in biotech or pharmaceutical settings, including clinical trial management.
• Experience managing study timelines, vendors, operational risks, study start-up, and site activation.
• Strong knowledge of ICH-GCP, FDA, and international clinical trial regulations.
• Experience with CTMS, EDC, eTMF, and Veeva eTMF or comparable document management systems.
• Strong organizational, communication, problem-solving, prioritization, and independent execution skills.

Nice to have

• Advanced degree.
• Experience in ophthalmology, advanced therapies, or small to mid-size biotech companies.
• Experience working in an unblinded study environment.
• Direct experience engaging investigators and study physicians.

Culture & Benefits

• Work in a fast-changing, resource-constrained environment with significant operational ownership.
• Collaborate across clinical, regulatory, biometrics, quality, finance, and external partner functions.
• Support gene therapy, cell therapy, and vaccine programs focused on unmet medical needs.
• Travel to investigator sites, meetings, and vendors as required.