Manager, RBQM

Location: Cambridge, Massachusetts, United States; hybrid 70/30 work model with 70% in-office collaboration. Ability to travel up to 20%.

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

Company

hirify.global develops mRNA technology and medicines to advance healthcare and scientific progress.

What you will do

• Support study- and program-level risk assessments, including CTQ factors, QTLs, KRIs, mitigation actions, and IQRMP maintenance.
• Configure and review centralized monitoring activities in platforms such as CluePoints.
• Perform data quality checks, support UAT, and analyze initial data, risk signals, and trends.
• Support monitoring oversight with clinical and vendor teams, including review of CRO and site monitoring documentation.
• Track monitoring metrics and issue trends and support corrective and preventive actions.
• Contribute to RBQM 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 clinical systems such as CTMS, EDC, risk assessment tools, and centralized monitoring platforms.
• Strong organizational, analytical, and communication skills with proficiency in Microsoft Office, including Excel.
• Only U.S. persons—citizens, permanent residents, asylees, or refugees—are eligible due to U.S. export control requirements; visa sponsorship for non-U.S. persons is unavailable.

Culture & Benefits

• In-person collaboration, teamwork, and direct mentorship supported by a 70/30 work model.
• Competitive healthcare and voluntary benefit programs.
• Fitness, mindfulness, and mental health resources.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
• Savings and investment programs plus location-specific perks.