Senior Manager, Monitoring Quality Oversight (Clinical Operations)

Location: South San Francisco, California, or San Diego, California; onsite four days per week with work-from-home flexibility. Travel of up to 80% is required.

Salary: $168,000–$208,000 per year.

Company

hirify.global is a precision medicine oncology company developing targeted small-molecule and antibody-drug conjugate therapies for molecularly defined solid tumors.

What you will do

• Conduct monitoring quality oversight visits across North American clinical studies.
• Develop study-specific monitoring oversight plans and review CRO monitoring plans and reports.
• Identify monitoring risks, data quality concerns, trends, and non-compliance, then coordinate corrective and preventive actions.
• Provide guidance to clinical operations teams, CRO monitors, and service providers on protocol deviations, adverse events, and data quality.
• Maintain monitoring compliance metrics, improve oversight processes, and support SOP development.
• Present oversight findings to senior management and coordinate with Quality Assurance on audits and inspections.

Requirements

• Bachelor’s degree in life science or an equivalent combination of education, training, and relevant experience.
• At least 6 years of relevant biotech or pharmaceutical experience, including 3 years focused on monitoring oversight.
• At least 3 years of oncology experience and experience in Clinical Operations.
• Thorough understanding of GCP, relevant ICH standards, FDA and EMA guidelines, and clinical trial processes.
• Experience managing CRO relationships and overseeing monitoring activities, supported by strong analytical, organizational, communication, and problem-solving skills.
• Proficiency with Microsoft Office, clinical trial management systems, and data management tools; Smartsheet experience is a plus.

Culture & Benefits

• Collaborative, inclusive, and data-driven environment focused on advancing oncology medicine.
• Medical, dental, and vision coverage, with premiums fully paid for employees and 90% paid for dependents.
• 401(k), employee stock purchase plan, wellness programs, and eligibility for incentive and stock option awards.
• Employees working in company facilities must be fully vaccinated, subject to applicable accommodations.