Manager, TMF Systems and Operations (Clinical Trials)

Location: Cambridge, Massachusetts, United States; only U.S. persons are eligible due to export control requirements.

Salary: $109,200–$174,600 per year, plus potential annual bonus, incentive compensation, or equity.

Company

hirify.global develops mRNA-based therapeutics and vaccines using its mRNA science, delivery technology, and manufacturing platform.

What you will do

• Manage daily CTMS operations, including study, country, and site setup, user provisioning, workflows, reporting, releases, and UAT.
• Set up and maintain TMF records throughout the clinical study lifecycle and ensure accurate, timely eTMF filing.
• Lead TMF quality reviews, health checks, reconciliation, and inspection-readiness activities across assigned studies.
• Reconcile CTMS and eTMF data, monitor operational metrics, and resolve data discrepancies.
• Partner with Clinical Operations, Data Management, Regulatory, QA, CROs, vendors, and IT on operational and technical issues.
• Improve SOPs, work instructions, templates, system processes, and end-user training.

Requirements

• Bachelor’s degree or equivalent work experience.
• At least 6 years of experience in clinical research or a related field, including 3 years of hands-on TMF and/or CTMS operations experience.
• Working knowledge of Veeva Vault Clinical Suite, including CTMS and eTMF, is preferred.
• Familiarity with ICH GCP and global clinical documentation requirements.
• Strong attention to detail, communication, organization, and ability to manage multiple priorities.
• Must qualify as a U.S. person under U.S. export control laws; non-U.S. persons are not eligible and visa sponsorship is unavailable.

Nice to have

• Experience supporting audits, inspections, mock inspections, or inspection-readiness checks.

Culture & Benefits

• Competitive healthcare and voluntary benefit programs.
• Fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
• Savings and investment programs plus location-specific benefits.