Clinical Trial Manager - Interventional Oncology and Embolization

Title: Clinical Trial Manager - Interventional Oncology & Embolization

Location: Maple Grove, MN, US, 55311

Department: Clinical

Job Description:

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.           

About the Role:
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.

Work Mode:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

Visa Sponsorship:

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
• 3+ years of previous experience performing oncology clinical research studies
• 3+ years of Project/trial management experience
• 3+ years of Financial acumen and budget management experience
• 3+ years of experience with CROs, other clinical vendors, and outsourced operations,

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

Requisition ID: 617703 

Minimum Salary: $ 99100 

Maximum Salary: $ 188300 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

 

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

 

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.