Clinical Trial Manager - Interventional Oncology & Embolization

Clinical Trial Manager - Interventional Oncology & Embolization

The Clinical Trial Manager will support the IO&E team focused on oncology new therapy development. In this role, you will have responsibility for leading cross-functional clinical teams in the design, planning, and execution of First In Human (FIH), Feasibility, and Expansion clinical trials, with a focus on agility, learning, and creative thinking to move forward quickly and identify new and breakthrough cancer therapies for our pipelines.

This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Leads and drives the project team in the planning, execution and management of all operational aspects of clinical oncology trials
• Leads, directs develops, and executes clinical studies and/or programs worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures
• Tracks development of and collaborates with the project team on all internal and external project materials, processes, manuals, plans, committees, study systems and all sponsor required regulatory submissions
• Interacts and collaborates with external physicians and key opinion leaders (KOLs)
• Responsible for overall clinical trial project budget and maintenance up to 25%, dependent on project life cycle.
• Includes, monthly maintenance, routine and quarterly variance review, forecasting and strategic planning within accepted variance targets
• Provides direction and oversight to Contract Resource Organization (CROs) and other clinical vendors
• Ensures the project team maintains a continuous state of audit readiness
• In collaboration with the project team, leads the proactive identification, assessment, and management of clinical study risks
• Supports development of presentations and/or presents on study progress, data, outcomes and risks to leadership
• Provides clinical input to product development activities; represents Clinical on product development team
• Domestic and international travel up to 10 to 15%, as required

Required qualifications:

• Minimum of a bachelor's degree
• Minimum of 5 years of oncology-related work experience or an equivalent combination of education and work experience
• Previous experience performing oncology clinical research studies, 1 3 years
• Project/trial management experience, 1 3 years
• Financial acumen and budget management experience, 1 3 years
• Experience with CROs, other clinical vendors, and outsourced operations, 1 3 years

Preferred qualifications:

• First In Human (FIH) or early feasibility, solid tumor, medical device and/or drug development experience
• Experience with engineering or product development teams preferred
• Ability to:
• Apply new ways of looking at problems, processes, or solutions to generate new ideas, approaches, and initiatives
• Maintain strategic perspective and independently implement action plans and align activities with project, program and business objectives without significant supervision
• Effectively collaborate and influence a broad range of global stakeholders
• Respond flexibly and positively under conditions of uncertainty or change