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Senior Manager - Clinical Operations Remote Job

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Date: Oct 1, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: (n/a); US-CA-Santa Rosa; US-CA-Valencia; US-CO-Colorado Springs; US-CO-Denver South; US-CO-Western/Grand Junction; US-CT-Hartford; US-FL-Ft. Myers/Naples; US-FL-Melbourne; US-FL-Pensacola/Panama City; US-GA-Alpharetta; US-GA-Central/Augusta; US-GA-Savannah; US-IA-Western/Sioux City; US-ID-Northern; US-IL-Bloomington/Peoria; US-IL-Rockford; US-OR-Portland; US-OR-Salem; US-OR-Southern; US-PA-Allentown; US-PA-Altoona; US-PA-Erie; US-PA-Harrisburg; US-PA-Philadelphia; US-PA-Pittsburgh; US-PA-State College; US-PA-Wilkes Barre; US-PA-York/Lancaster; US-RI-Coventry; US-TN-Knoxville; US-TN-Nashville; US-TX-Amarillo/Lubbock; US-TX-Dallas; US-TX-El Paso; US-TX-Houston; US-VA-McLean/Arlington; US-VA-Northern; US-VA-Roanoke; US-VT-Southern; US-WA-Central/Yakima; US-WA-Seattle; US-WI-Green Bay/Appleton; US-WI-Madison; US-WI-Milwaukee; US-WI-Northern; US-WV-Northern; US-WV-Southern; US-WY-Casper; US-WY-Cheyenne

 

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.

Senior Manager – Clinical Operations - Remote

 

About this position:

 

Purpose Statement

  • This senior level position within the Interventional Cardiology Clinical Operations organization serves as subject matter expert and advisor to Interventional Cardiology Clinical project management and senior Clinical management on any Monitoring/Site Management and Trial Operations related matters.  This position acts as main contact for our CRO partners and oversees performance and trends on site start-up, monitoring/site management and trial operations services, ensures applicable regulations and standards for medical devices are applied and clinical program and department commitments are achieved.  This position heavily interfaces and collaborates with other functions and departments across BSC Clinical organization and contributes to process improvements and innovations. The person can be located in Marlboro, MA,  Maple Grove, MN, or remote

 

 

Key Responsibilities

  • Acts as Subject Matter Expert to the Interventional Cardiology Clinical Leadership team and project teams on Start-Up, Monitoring and Site Management (including Trial Operations) aspects of clinical research.
  • Provides guidance on start-up, site management and monitoring practices in medical device arena to advise clinical project teams and clinical leadership with continuous improvement objectives of quality, simplification, efficiency, and cost control.
  • Represents Interventional Cardiology Clinical as on global initiatives and workstreams related to development of polies and procedures, implementation of global clinical systems (ie CTMS, TMF, etc …)  and new regulations
  • Oversees work of CROs through meaningful metrics to ensure timelines, quality and budget agreements are met.
  • Provides work direction, guidance, mentoring, and support to CROs and internal staff.

 

What we are looking for:

Required Qualifications:

  • Bachelor’s degree Required in Life Science related fields such as nursing, Pharmacy, Health Science,
  • 10+ years of related work experience.
    • Including 5+ years experience in monitoring/site management in medical device industry
    • Including 4+ years experience in direct or indirect management of monitoring and site management staff
  • Knowledge of laws, regulations, and guidance governing the conduct of pre- and post-market clinical studies on medical devices in the US and International.
  • Solid experience in working with and/or overseeing of CROs
  • Experience working in a cross-functional team setting in different locations and geographical regions
  • Proven experience working with EDC, trial management, reporting and documentation systems
  • Proven experience in supporting internal audits and FDA and/or other regulatory body audits  
  • Proven experience contributing or leading department / organizational initiatives with major impact on process improvement and work efficiencies
  • Strong communication and presentation skills
  • Able to work independently and to solve complex problems
  • Able to travel approximately 10% to meetings and other BSC facilities

 

Preferred Qualifications:

  • Advanced degree in Life Science related fields and related work experience preferred
  • Experience working with products/studies of the BSC Interventional Cardiology division ie coronary therapy products, cardiac / mitral heart valves is preferred
  • Solid work experience and understanding of Medidata RAVE and Veeva Vault, able to contribute to implementation and improvement initiatives
  • Customer focus, able to develop an excellent relationship with CRO partner, and internal teams

 

 

 

Requisition ID: 502762

 

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!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

 


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