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Clinical Site Management Director

2 months ago

Waltham, Massachusetts, United States Upstream Bio Full time
Job Title: Clinical Site Management Director

We are seeking a seasoned professional to lead our clinical site management efforts across global clinical trials. As a key member of our clinical operations team, you will be responsible for establishing and overseeing site management and monitoring activities, ensuring high-quality delivery of clinical sites in a fully outsourced model.

Key Responsibilities:
  • Plan, establish, and oversee site management and monitoring oversight activities and capabilities in a global setting.
  • Partner with clinical operations leaders and cross-functional teams to identify and mitigate site-level and patient-level risks.
  • Oversee the implementation, execution, and delivery of site management and monitoring activities across studies by CROs, ensuring alignment with timeline and budget plans.
  • Provide leadership and implement solutions to support Sponsor oversight of site management and monitoring activities across indications.
  • Ensure compliance with internal policies and procedures, GCPs, and applicable regulations, ensuring inspection readiness.
Qualifications:
  • Extensive experience (10+ years) in clinical development and operations, with site-facing experience required.
  • Experience in leading implementation of oversight activities to mitigate key site-level and patient-level risks to clinical trials.
  • Experience managing or overseeing site monitoring and/or central monitoring roles/contractors for global trials, with direct line/functional management experience preferred.
  • Data-driven professional with knowledge of best practices, tools, and systems to enable efficient and risk-oriented oversight approaches.
  • Bachelor's Degree or international equivalent required; Life Sciences preferred, with advanced degree highly desirable.
Skills, Knowledge & Abilities:
  • Strong leadership skills driving large cross-functional teams.
  • Deep knowledge of global regulatory and compliance requirements for clinical research, local country requirements, and ICH GCP, including experience with global regulatory inspections.
  • Excellent critical and strategic thinking, with strong ability to understand the big picture as well as important details that may impact the big picture.
  • Global clinical operations & development experience across therapeutic areas, with demonstrated ability to rapidly learn new indications.
  • Excellent communicator and influencer, able to persuasively convey both ideas and data, verbally and in writing.