Principal Clinical Research Manager

Additional Locations: US-MN-Arden Hills; US-MN-Mankato/Rochester

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: 
We are looking for a Principal Clinical Research Manager to define clinical services provided by the cardiac diagnostics clinical services team and lead the team in providing the offered services.  The clinical services team supplies ambulatory ECG monitoring services for internal and customer driven clinical research projects.  The cardiac diagnostics clinical services team is part of the Cardiac Diagnostics group within Cardiac Rhythm Management.  

In this role, you will be partnering with most cross functional teams within Cardiac Diagnostics to build and refine processes that the team will use to support clinical research projects.  You will work cross functionally to map cardiac diagnostic clinical services to proposed clinical projects and manage the team providing the cardiac diagnostic clinical services during execution of the clinical research projects.  

Your responsibilities will include:
⦁    Lead efforts and the clinical services team to coordinate resources and plans cross-functionally with Product Management, R&D, Operations, Clinical Lab, Legal, Compliance, Regulatory, and Marketing to support internally defined and commercially defined research projects   
⦁    Create, enhance, and maintain standard operating procedures, work instructions and quality standards used by the clinical services team 
⦁    Ensures conformance of the clinical services team to standard operating procedures, work instructions and quality standards
⦁    In consultation with Product Management, Marketing, Medical Science and Medical Affairs helps plan and drive the cardiac diagnostics scientific clinical research roadmap to support the strategic direction of the group’s products and services
⦁    Oversees the clinical services direction, planning, development, and execution of clinical research projects and studies funded by the cardiac diagnostics group
⦁    Collaborates with other business units that require cardiac diagnostics clinical services to support their studies 
⦁    Supports the scientific value assessment and sponsorship decisions of proposed investigator-led and collaborative research activities
⦁    Provide clinical inputs to Product Management for future product improvements and new features
⦁    Develop, track, and report clinical services quality metrics
⦁    Provides monthly updates on internal and sponsored cardiac diagnostics research projects used for tracking and status reporting to upper management
⦁    Ensure clinical services compliance with applicable federal and international regulations and standards for human research
⦁    Represents cardiac diagnostics clinical services as a clinical research domain expert in meetings and at conferences
⦁    Helps develop and maintain effective business relationships with study sponsors, CROs and core lab partners

Required qualifications: 
⦁    Bachelor’s degree required 
⦁    Minimum of 3 years’ experience working with clinical research activities in a commercial medical device setting
⦁    Working understanding of clinical research regulations and Good Clinical Practices
⦁    Experience with or understanding of commercial cardiac diagnostic monitoring service types
⦁    Ability to travel up to 20%

Preferred qualifications: 
⦁    MBA or advanced degree
⦁    Understanding of Boston Scientific quality system and cardiac clinical research activities
⦁    Experience managing a small team
⦁    Experience with software and hardware medical devices
⦁    Strong presentation and public speaking skills
 

Requisition ID: 561114

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.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!