Global Clinical Monitoring Oversight Director

Olema Oncology; Boston (MA); Sur place; USD 235 000 - 250 000; Plein temps

Avantages offerts par ce poste

Equity

Bonus

Benefits

Résumé du poste

Olema Oncology seeks a Director, Clinical Monitoring Oversight to lead global monitoring strategy across clinical programs, ensuring GCP compliance, data integrity, and inspection readiness. You’ll oversee COMLs, CROs/FSPs, and regional teams, driving risk-based monitoring and continuous improvement in quality and efficiency.

The role is based in San Francisco or Cambridge with 10–20% travel; you will partner with Clinical Operations, Data Management, and QA to align monitoring plans with study

Qualifications

• Bachelor's/Master in a scientific discipline required.
• Expert knowledge of global clinical monitoring oversight strategies and execution.
• Deep understanding of ICH-GCP, global regulatory requirements, and inspection readiness.
• Strong knowledge of vendor governance models, KPI frameworks, and quality management systems.
• Broad understanding of clinical development and cross-functional clinical operations.

Responsabilités

• Provide strategic direction and operational oversight of global monitoring activities across Olema’s clinical programs.
• Oversee internal monitoring and/or oversight teams and FSPs, ensuring alignment and accountability.
• Adapt monitoring strategies and operating models to evolving development and business needs.
• Manage monitoring budgets, forecasts, and resource planning aligned with study priorities.
• Establish governance with FSP partners including performance management and risk mitigation.
• Define and implement monitoring strategies aligned with ICH-GCP and regulatory expectations.
• Ensure harmonization of processes, training, and documentation across programs and regions.
• Develop KPIs and quality metrics to evaluate site performance and vendor delivery.

Connaissances

Strategic leadership

Team leadership

Cross-functional collaboration

Vendor governance

ICH-GCP knowledge

Regulatory knowledge

Data-driven decision making

Formation

Bachelor's/Master's in scientific discipline

Description du poste

Olema Oncology seeks a Director, Clinical Monitoring Oversight to lead global monitoring strategy across clinical programs, ensuring GCP compliance, data integrity, and inspection readiness. You’ll oversee COMLs, CROs/FSPs, and regional teams, driving risk-based monitoring and continuous improvement in quality and efficiency.

The role is based in San Francisco or Cambridge with 10–20% travel; you will partner with Clinical Operations, Data Management, and QA to align monitoring plans with study