Director, Clinical Site Management and Oversight

1 week ago


Waltham, Massachusetts, United States Upstream Bio Full time
Job Summary

We are seeking a seasoned professional to lead our clinical site management and monitoring efforts. As a key member of our clinical operations team, you will be responsible for establishing and overseeing site management and monitoring activities across global clinical trials.

Key Responsibilities
  • Site Management and Monitoring Oversight: Plan, establish, and oversee site management and monitoring activities in a global setting, ensuring high-quality implementation, execution, and delivery of site management and monitoring activities across studies by CROs.
  • Risk Management: Partner with clinical operations leaders and cross-functional teams to identify and mitigate site-level and patient-level risks, ensuring compliance with internal policies and procedures, GCPs, and applicable regulations.
  • Leadership and Collaboration: Provide leadership and implement solutions to support Sponsor oversight of site management and monitoring activities across indications, ensuring effective collaboration with investigational sites, clinical operations leaders, and clinical vendor oversight leads.
  • Compliance and Quality Assurance: Ensure compliance with internal policies and procedures, GCPs, and applicable regulations, and maintain inspection readiness.
Requirements
  • Experience: 10+ years of relevant experience in clinical development and operations, with site-facing experience and leadership experience in implementing oversight activities to mitigate key site-level and patient-level risks.
  • Education: Bachelor's Degree or international equivalent required; Life Sciences preferred. Advanced degree highly desirable.
  • Skills and Knowledge: Strong leadership skills, deep knowledge of global regulatory and compliance requirements, excellent critical and strategic thinking, and ability to travel approximately 10-15% of the time.


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