Senior Clinical Trial Manager - Electrophysiology

Boston Scientific • Johns Creek, GA

11d

About The Position

Your responsibilities will include: Provide end-to-end operational leadership for global electrophysiology clinical trials, with accountability for study planning, execution and delivery across first-in-human, IDE and post-approval phases. Develop and maintain integrated clinical trial plans, including protocols, study-specific plans, timelines and risk mitigation strategies, ensuring alignment with clinical and program-level objectives. Ensure clinical trial conduct complies with applicable regulations, ICH-GCP and internal quality systems, maintaining a continuous state of inspection and audit readiness. Support transitions between study phases (e.g., first-in-human to IDE, IDE to post-approval) by adapting operational plans, documentation and execution approaches to meet changing evidence-generation needs.

Requirements

• Bachelor's degree in a scientific, health care or related discipline, or a minimum of 8 years' relevant clinical research experience gained through progressive roles in clinical trial execution (typically equivalent to full-time experience replacing a bachelor's degree).
• Minimum of 8 years' experience managing clinical trials or clinical programs, including global and/or multi-site studies across different phases of development.
• Demonstrated experience executing clinical trials in compliance with ICH-GCP, FDA and global regulatory requirements, including first-in-human, IDE and post-approval environments.
• Ability to travel up to 25%, including domestic and international travel as required.
• Strong ability to generate new ideas and approaches by applying creative thinking to complex and ambiguous problems.
• Strong ability to align execution with strategic goals and independently drive action amid changing priorities and limited direction.
• Strong ability to collaborate and influence across global, cross-functional teams with differing objectives and timelines.
• Strong ability to adapt quickly and remain effective under shifting clinical, regulatory and portfolio conditions.

Nice To Haves

• Advanced degree such as MS, MPH or PhD.
• Medical device clinical trial experience, preferably within electrophysiology, cardiology or rhythm management.
• Hands-on experience supporting first-in-human, IDE and/or post-approval electrophysiology studies, including atrial fibrillation or flutter ablation therapies.

Responsibilities

• Provide end-to-end operational leadership for global electrophysiology clinical trials, with accountability for study planning, execution and delivery across first-in-human, IDE and post-approval phases.
• Develop and maintain integrated clinical trial plans, including protocols, study-specific plans, timelines and risk mitigation strategies, ensuring alignment with clinical and program-level objectives.
• Ensure clinical trial conduct complies with applicable regulations, ICH-GCP and internal quality systems, maintaining a continuous state of inspection and audit readiness.
• Support transitions between study phases (e.g., first-in-human to IDE, IDE to post-approval) by adapting operational plans, documentation and execution approaches to meet changing evidence-generation needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level