Director, Clinical Monitoring Oversight

Role Summary

Director, Clinical Monitoring Oversight is responsible for strategic and operational leadership of global clinical site monitoring across Olema’s programs, ensuring high standards of quality and compliance with GCP. The role oversees Monitoring Oversight Leads, regional monitoring teams, and site performance, and develops worldwide monitoring strategies to drive operational excellence, data integrity, and inspection readiness.

Responsibilities

• Provide strategic direction and operational oversight of all global monitoring activities across Olema’s clinical programs
• Oversee internal clinical monitoring oversight team and FSP vendor responsible for providing Regional Site Monitoring Leads (RSMLs), ensuring alignment, consistency, and accountability across global regions
• Establish and maintain effective governance with the FSP partner, including performance management, risk mitigation, and continuous improvement in monitoring quality and efficiency
• Define and implement Olema’s monitoring strategy, including risk-based and centralized monitoring approaches in alignment with ICH-GCP and regulatory expectations
• Ensure global harmonization of clinical monitoring processes, training, and documentation across programs and regions
• Develop and monitor key performance indicators (KPIs) and quality metrics to evaluate site performance, FSP delivery, and regional oversight effectiveness
• Collaborate with Clinical Operations, Data Management, Clinical Quality, and Clinical Development to ensure monitoring activities are aligned with program objectives and timelines
• Contribute to the development and review of key operational documents, including Monitoring Plans, Oversight Plans, Risk Management Plans, and audit/inspection responses
• Proactively assess monitoring risks and implement mitigation strategies to maintain inspection readiness
• Lead, manage, and mentor internal monitoring oversight staff, fostering collaboration, accountability, and continuous improvement
• Serve as the Monitoring Oversight representative on cross-functional and governance teams, presenting program updates, risks, and mitigation strategies to senior management
• Drive innovation and process optimization in monitoring oversight practices, including leveraging technology and data analytics to enhance quality and efficiency

Qualifications

• Knowledge: Bachelor's or Master’s degree in a scientific discipline or related field is required; strong understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements related to monitoring and clinical trial conduct
• Experience: Minimum 12 years of clinical operations experience in the pharmaceutical or biotech industry; minimum 5 years direct site monitoring experience with a strong understanding of site operations and clinical trial execution; minimum 5 years in a role providing global monitoring oversight, including oversight of clinical site monitors, FSP/CRO management, monitoring quality metrics, KPIs, and governance, with a track record of driving performance improvement and corrective action plans; experience overseeing regional monitoring functions; oncology experience is required
• Attributes: Demonstrated ability to manage FSP or CRO partnerships, contract governance, KPI development, and issue escalation; skilled in risk-based monitoring methodologies and oversight tools; strategic thinker with excellent communication, leadership, and interpersonal skills; strong analytical and problem-solving abilities; able to manage competing priorities in a fast-paced environment

Education

• Bachelor's or Master’s degree in a scientific discipline or related field (required)

Skills

• Risk-based monitoring methodologies
• Governance, performance management, and oversight of external vendors (FSPs/CROs)
• Data analytics and KPI/quality metric development
• Cross-functional collaboration and senior leadership communication
• Regulatory knowledge (ICH-GCP, FDA, EMA)

Additional Requirements

• Travel: Approximately 15% travel required