Monitoring Quality Lead, Clinical Operations (Biotech)

IDEAYA Biosciences; San Diego (CA); On-site; USD 168,000 - 208,000; Full time

Benefits offered by this job

Medical/dental/vision coverage

401k

ESPP

Wellness programs

Job summary

IDEAYA Biosciences is seeking a Monitoring Quality Oversight Manager in Clinical Operations. The role focuses on overseeing CRO monitoring activities to ensure high data quality and compliance with regulatory standards.

You will work onsite four days a week at South San Francisco or San Diego offices and travel up to 80% to support clinical trials and drive continuous improvement in monitoring practices.

Qualifications

• Bachelor’s degree in life sciences or equivalent.
• Minimum 6 years in biotech/pharma, with 3 years in monitoring oversight.
• At least 3 years in oncology.
• Strong knowledge of GCP, ICH, FDA/EMA guidelines.

Responsibilities

• Conduct monitoring oversight visits across North America to ensure protocol compliance and data integrity.
• Develop and implement monitoring oversight plans aligned with study goals and timelines.
• Review monitoring plans for robustness and best practices in clinical monitoring.
• Evaluate monitoring reports and develop action plans for non-compliance or data quality concerns.

Skills

MS Office

Clinical operations

GCP knowledge

Regulatory knowledge

Data analysis

Travel readiness

Education

Bachelor’s Degree in life science

Tools

Smartsheet

CTMS

Data management tools

Adobe Acrobat

Job description

IDEAYA Biosciences is seeking a Monitoring Quality Oversight Manager in Clinical Operations. The role focuses on overseeing CRO monitoring activities to ensure high data quality and compliance with regulatory standards.

You will work onsite four days a week at South San Francisco or San Diego offices and travel up to 80% to support clinical trials and drive continuous improvement in monitoring practices.