Senior Clinical Trial Manager

Gateway Recruiting
Boston, MA

About the role:

The Clinical Trial Manager, Oncology will play a key leadership role within the Interventional Oncology & Embolization (IO&E) team, driving the design and execution of cutting-edge oncology clinical trials. This position is responsible for leading cross-functional teams on Early Feasibility Studies (EFS) and Phase II–III pivotal trials, with a strong focus on agility, innovation, and learning to advance the Company’s oncology pipeline. This role will help shape the future of cancer care by enabling access to novel therapies and breakthrough technologies.

Locations:  Boston, MA or Minneapolis/St. Paul, MN

Responsibilities will include:

  • Leading and driving the cross-functional project team in the planning, execution, and operational management of oncology clinical trials
  • Designing, directing, and executing global clinical studies in alignment with program strategy, approved budget, and timelines, in compliance with regulatory and operational procedures
  • Collaborating on development and oversight of internal and external project materials, including study manuals, systems, and regulatory submissions
  • Interfacing and building relationships with external physicians and key opinion leaders (KOLs)
  • Managing clinical trial budgets (up to 25%), including monthly tracking, forecasting, and variance analysis
  • Providing directions to Contract Research Organizations (CROs) and external vendors
  • Ensuring audit readiness and compliance across all clinical trial activities
  • Leading proactive risk identification, assessment, and mitigation planning for assigned studies
  • Preparing and delivering study updates, presentations, and risk assessments to leadership
  • Contributing clinical insights into product development activities and serving as a Clinical team representative on product development teams
  • Traveling domestically up to 10–25%, as required

 

Qualifications:

Required qualifications:

  • Bachelor’s degree and minimum of 5 years' experience in oncology-related clinical research or equivalent education and work experience
  • Minimum of 1 year of direct oncology clinical trial management experience
  • Minimum of 1 year of financial oversight and budget management experience
  • Minimum of 1 year working with CROs, vendors, or outsourced clinical operations

Preferred qualifications:

  • Experience in early feasibility studies, solid tumor trials, or immuno-oncology (IO) product development
  • Background working with engineering or product development teams
  • Strong ability to:
    • Generate new ideas and approaches by applying creative thinking to complex problems
    • Align execution with strategic goals and independently drive action without close supervision
    • Collaborate and influence across global, cross-functional teams
    • Adapt quickly and stay effective under changing conditions
Posted 2025-11-12

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