Clinical Site Management and Monitoring Lead

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 in alignment with timeline and budget plan.
  • 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 for and implement solutions and capabilities 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, ensuring inspection readiness and maintaining a high level of quality assurance.
Requirements
  • Experience: 10+ years of relevant experience in clinical development and operations, with site-facing experience and experience in leading implementation of oversight activities to mitigate key site-level and patient-level risks to clinical trials.
  • 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 for clinical research, local country requirements, and ICH GCP, excellent critical and strategic thinking, and ability to travel approximately 10-15% of the time.


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