Director, Clinical Site Monitoring Oversight

Compass Consulting

  • Brisbane, CA
  • Permanent
  • Full-time
  • 1 month ago
Our client develops new therapies that meet the critical needs of people of all ages living with cancer.POSITION SUMMARY:The Director, Clinical Site Monitoring Oversight is responsible for ensuring robust sponsor oversight of site monitoring activities across all phases of clinical development. This leadership role ensures operational excellence, compliance, and continuous improvement of monitoring execution, with a focus on monitoring processes, planning, and training excellence. The Director also plays a critical role in maintaining Trial Master File (TMF) inspection readiness and ensuring alignment with regulatory and GCP expectations.This role reports to Senior Director, Development Operations.This position has the potential to be fully remote. Domestic US and International travel of up to 30-40%, and in support of trial activitiesESSENTIAL DUTIES AND RESPONSIBILITIES:
  • Develop and maintain sponsor monitoring oversight strategies and plans, including oversight monitoring visits, quality review activities, and escalation pathways (including PSSV, SIV, etc.) based on audit and inspection findings to close critical gaps.
  • Track activities and the vendor oversight plans and ensure compliance at the site level.
  • Provide strategic oversight and performance management of CRO partners responsible for site monitoring, ensuring execution is compliant with ICH-GCP, regulatory requirements, and study plans.
  • Establish, track, and analyze KPIs and quality metrics for monitoring activities; lead risk assessments and performance reviews with CROs.
  • Conduct sponsor visits to oversee CRO performance, monitor critical data and processes, and support issue resolution.
  • Collaborate with CQA and study leads to develop study and vendor oversight plan, identify risks and corrective actions across the department and study sites.
Inspection Readiness
  • Serve as a TMF functional area lead to ensure continuous TMF health, completeness, and compliance across all trials.
  • Collaborate with study teams, CQA and regulatory to support audit and inspection preparation, including documentation reconciliation, CAPA management, and inspection activities (this includes site inspection preparation).
TMF Site Oversight
  • Support TMF inspection readiness.
  • Review ISF and TMF for reconciled documents that meet quality standards.
  • Participate in TMF oversight for Day One
  • Recommend updates or changes to processes as Day One matures the TMF process
Leadership and Collaboration
  • Serve as a senior representative of Development Operations in cross-functional meetings, providing insight and oversight related to site monitoring, TMF, and training strategy.
  • Mentor and guide internal team members and contribute to the professional development of CRO monitors when applicable.
  • Support departmental initiatives, SOP development, and inspection readiness plans.
QUALIFICATIONS:
  • Bachelor’s degree in life sciences or a related field required; advanced degree (MS, PharmD, PhD) preferred.
  • 10+ years of clinical research experience, including 5+ years in sponsor-side oversight of CRO monitoring activities.
  • Proven expertise in clinical site management, CRO/vendor oversight, and monitoring visit execution.
  • Strong knowledge of ICH-GCP, FDA and global regulatory requirements.
  • Demonstrated experience in leading site monitoring processes and training programs.
  • Deep understanding of TMF requirements and inspection readiness.
  • Excellent leadership, communication, organizational, and problem-solving skills.
  • Proficiency in eTMF platforms (e.g., Veeva Vault), CTMS, and clinical documentation systems.

Compass Consulting