Clinical Trial Manager

Boston Scientific • Arden Hills, MN

398d • $109,900 - $208,800 • Hybrid

About The Position

The Clinical Trial Manager is responsible for the design, planning, execution, and leadership of clinical studies and clinical programs worldwide. This role involves leading cross-functional clinical teams to support the organization's business objectives for product development and commercialization, requiring a strong technical knowledge of products, processes, and regulatory requirements for clinical trials in a specific therapeutic area.

Requirements

• Minimum Bachelor's degree in a health-care related field.
• Minimum 7 years of related work experience or an equivalent combination of education and work experience.
• Minimum 3 years of experience managing clinical trials.

Nice To Haves

• Proven experience leading clinical trials with investigational devices, specifically in electrophysiology or cardiology.
• Ability to use in-depth knowledge of business unit functions and cross-functional group dependencies.
• Proven experience working with and managing external vendors.

Responsibilities

• Writes study protocols, protocol amendments, informed consents, clinical study project timelines, and scientific papers for publication.
• Leads the development of clinical strategy and trial design by conducting meetings with appropriate departments and individuals.
• Provides clinical input for new product development, post-market surveillance, recertification, and business development.
• Interacts with regulatory agencies and provides directives to staff and study sites.
• Facilitates communication between various departments and stakeholders by conducting team meetings and presenting updates to senior staff.
• Manages clinical study timelines and budgets, ensuring expenditures are within budgetary guidelines.
• Facilitates regulatory submissions and communications with Regulatory Affairs during the submission process.
• Presents scientific data at industry gatherings and may author scientific abstracts and publications.
• Provides accurate progress reports on clinical projects for submission to regulatory agencies and ethics committees.

Benefits

• Competitive salary with annual bonus eligibility.
• Access to the latest tools, information, and training for career advancement.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree