Manager, RWE Study Operations (Real-World Evidence)

Location: Cambridge, Massachusetts, United States. Hybrid 70/30 work model with 70% in-office collaboration. Only U.S. persons are eligible due to U.S. export control requirements; visa sponsorship is not available.

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

Company

hirify.global develops mRNA technology and medicines through a science-focused biotechnology platform.

What you will do

• Manage day-to-day operations for approximately 6–10 Real-World Evidence studies across safety, registry, epidemiological, effectiveness, and integrated evidence programs.
• Lead cross-functional study teams and coordinate scientific, regulatory, clinical, vendor, and research partner activities.
• Manage CROs, vendors, contracts, budgets, invoices, forecasts, timelines, risks, and operational performance.
• Maintain study plans, documentation, metrics, Trial Master Files, data transfer specifications, and study reports.
• Oversee data quality, biomarker sample tracking, regulatory submissions, disclosures, and compliance with applicable standards.
• Lead study closeout activities and identify improvements to study execution and RWE operating models.

Requirements

• 4+ years of experience in clinical research and industry, including at least 2 years of independent study or project management experience, preferably at a sponsor company.
• Bachelor’s degree required; advanced degree preferred.
• Experience in observational research, trial management, or program management across study development phases and the full study lifecycle.
• Experience managing CROs, vendors or research partners, contracts, budgets, and operational performance.
• Working knowledge of FDA and ICH GCP, Good Pharmacoepidemiology Practices, and applicable regulatory guidance.
• Must qualify as a U.S. person under U.S. export control laws; non-U.S. persons cannot be sponsored for an export control license.

Nice to have

• Experience with Real-World Evidence across the product lifecycle.
• Experience with AI-enabled productivity tools such as ChatGPT or Microsoft Copilot.

Culture & Benefits

• In-person collaboration model with direct teamwork and mentorship.
• Healthcare and voluntary benefit programs.
• Fitness, mindfulness, mental health, family planning, fertility, adoption, and surrogacy support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
• Savings and investment programs, plus location-specific benefits.