TMF Lead

Location: Malvern, Pennsylvania, United States; office-based with up to 10% travel to sites, vendors, or CROs

Company

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

What you will do

• Lead TMF activities across assigned clinical studies from startup through closeout and archival in Veeva Vault.
• Own TMF completeness, quality control, inspection readiness, health checks, reconciliations, KPIs, and quality metrics.
• Configure and administer Veeva Vault eTMF, including access roles, metadata, document classification, workflows, upgrades, and migrations.
• Coordinate TMF activities with Clinical Operations, Data Management, Regulatory Affairs, Biostatistics, Pharmacovigilance, CROs, and vendors.
• Support sponsor audits and regulatory inspections, including document retrieval, inspection preparation, remediation, and CAPA implementation.
• Develop TMF plans, filing strategies, SOPs, training, and continuous-improvement initiatives while managing multiple studies independently.

Requirements

• Bachelor’s degree in life sciences or a related field; an advanced degree is a plus.
• 5–7 years of progressive clinical research experience in biotechnology or pharmaceuticals, with significant TMF operations experience.
• Hands-on TMF management across the full trial lifecycle and direct Veeva Vault eTMF configuration and administration experience.
• Knowledge of the DIA TMF Reference Model, Expected Document List management, ICH-GCP, and FDA, EMA, and MHRA requirements.
• Experience supporting audits or regulatory inspections, TMF remediation, CRO/vendor oversight, and TMF quality-control processes.
• Ability to work independently, prioritize competing study timelines, communicate cross-functionally, and maintain detailed document and records management.

Nice to have

• Experience in ophthalmology or Phase 1–3 cell and gene therapy studies.
• Experience with CTMS, EDC, and RTSM systems.
• Advanced degree in a relevant field.

Culture & Benefits

• Work in a small biotech environment with competing priorities and limited resources.
• Collaborate across clinical, regulatory, data, safety, quality, and external vendor functions.
• Availability outside standard hours may be required for priority business needs.
• Travel may include visits to clinical sites, vendors, and CROs, up to 10%.