Manager, RBQM (Clinical Research)

Location: Cambridge, Massachusetts, United States; 70% in-office work model. Ability to travel up to 20%. Only U.S. persons are eligible due to U.S. export control requirements.

Salary: $109,200–$174,600 per year, with potential eligibility for an annual discretionary bonus, other 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

• Support study- and program-level risk assessments, including CTQ factors, QTLs, KRIs, and mitigation actions.
• Help develop and maintain Integrated Quality Risk Management Plans and risk management documentation.
• Set up and review centralized monitoring activities, including KRI and QTL configuration in platforms such as CluePoints.
• Perform data quality checks, support UAT, review trends, and investigate potential risk signals.
• Support monitoring oversight activities with clinical teams, vendors, CROs, and sites.
• Contribute to training, process improvement, audit preparation, and inspection readiness.

Requirements

• Bachelor’s degree or equivalent work experience; life sciences, healthcare, or a related field is preferred.
• At least 6 years of experience in clinical research, clinical operations, or a related field, including at least 1 year of exposure to risk management, centralized monitoring, or RBQM.
• Working knowledge of GCP, ICH E6(R2)/R3, and regulatory guidelines.
• Experience with CTMS, EDC, risk assessment tools, and centralized monitoring platforms.
• Strong organizational, analytical, and communication skills, with proficiency in Microsoft Office and Excel.
• Must qualify as a U.S. person; the role is subject to U.S. export control laws and does not sponsor non-U.S. persons for export control licenses.

Culture & Benefits

• 70/30 work model emphasizing in-office collaboration, teamwork, innovation, and mentorship.
• Healthcare and voluntary benefit programs.
• Fitness, mindfulness, mental health, and well-being resources.
• Family planning support, including fertility, adoption, and surrogacy benefits.
• Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
• Savings and investment programs plus location-specific perks.