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Senior Clinical Operations Manager

2 months ago

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

Job Title: Director, Clinical Site Management

Company: Upstream Bio

Job Summary:

We are seeking a seasoned professional to lead our clinical site management 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:

  • Develop and Implement Site Management Strategies: Plan, establish, and oversee site management and monitoring oversight activities and capabilities as part of the clinical operations team.
  • Collaborate with Cross-Functional Teams: Partner with clinical operations leaders and cross-functional teams to support effective risks identification and mitigations/resolutions, with focus on site-level and patient-level risks.
  • Ensure High-Quality Site Management: Oversee high-quality implementation, execution, and delivery of site management and monitoring activities across studies by CROs in alignment with timeline and budget plan.
  • Lead Site Management and Monitoring Activities: Provide leadership for and implement solutions and capabilities to support Sponsor oversight of site management and monitoring activities across indications.
  • Ensure Compliance and Inspection Readiness: Ensure compliance with internal policies and procedures, GCPs, and applicable regulations; ensure inspection readiness.

Qualifications:

  • Extensive Experience in Clinical Development and Operations: 10+ years of relevant experience in clinical development and operations.
  • Site-Facing Experience: Site-facing experience required (as clinical coordinator, CRA/site monitor).
  • Leadership Experience: Experience in leading implementation of oversight activities to mitigate key site-level and patient-level risks to clinical trials.
  • Global Clinical Operations Experience: Experience managing or overseeing site monitoring and/or central monitoring roles/contractors for global trials (direct line/functional management experience preferred).
  • Data-Driven Professional: Data-driven professional with knowledge of best practices, tools, and systems to enable efficient and risk-oriented oversight approaches.
  • Advanced Degree: Bachelor's Degree or international equivalent required; Life Sciences preferred. Advanced degree highly desirable.

Skills, Knowledge & Abilities:

  • Strong Leadership Skills: Strong leadership skills driving large cross-functional teams.
  • Global Regulatory Knowledge: Deep knowledge of global regulatory and compliance requirements for clinical research, local country requirements, and ICH GCP, including experience with global regulatory inspections.
  • Critical and Strategic Thinking: Excellent critical and strategic thinking, with strong ability to understand the big picture as well as the important details that may impact the big picture.
  • Global Clinical Operations Experience: Global clinical operations & development experience across therapeutic areas with demonstrated ability to rapidly learn new indications.
  • Excellent Communication Skills: Excellent communicator and influencer, able to persuasively convey both ideas and data, verbally and in writing.
  • Travel Requirements: Ability to travel approximately 10-15% of the time.