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Manager l, Clinical Monitoring & Study Site Management (Oversight/advisor role) -Remote Job

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Remote in Country
Onsite Location(s): 

Marlborough, MA, US, 01752

Additional Location(s): US-MA-Marlborough; US-FL-Orlando; US-FL-Pensacola/Panama City; US-FL-St. Petersburg; US-FL-Tallahassee; US-FL-Tampa; US-FL-West Palm Beach; US-GA-Alpharetta; US-GA-Atlanta; US-GA-Central/Augusta; US-GA-Macon; US-GA-Savannah; US-GA-Southwest; US-IL-Bloomington/Peoria; US-IL-Chicago; US-IL-Quincy; US-IL-Rockford; US-IL-Springfield/Champaign; US-IN-Bloomington; US-IN-Evansville; US-IN-Fort Wayne; US-IN-Gary/Merrillville; US-IN-Indianapolis; US-IN-Lafayette; US-IN-South Bend; US-KS-Kansas City; US-KS-Overland Park; US-KS-Topeka/Manhattan; US-KS-Wichita Western; US-KY-Bowling Green/Paducah; US-KY-Lexington; US-KY-Louisville; US-MA-Lexington; US-MA-Lowell; US-MA-Natick; US-MA-Quincy; US-MA-Western/Springfield; US-MA-Worcester; US-MD-Baltimore; US-MD-Columbia; US-MD-Hunt Valley; US-MD-Montgomery County; US-MD-Rockville; US-MD-Salisbury; US-ME-Central/Augusta; US-ME-Northern/Bangor; US-ME-Southern/Portland; US-MI-Ann Arbor; US-MI-Detroit; US-MI-Flint/Saginaw; US-MI-Grand Rapids; US-MI-Kalamazoo; US-MI-Lansing; US-MI-Northern; US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Minnetonka; US-MN-Northern/Duluth; US-MN-Plymouth; US-NC-Charlotte; US-NC-Eastern/Greenville; US-NC-Greensboro; US-NC-Raleigh/Durham; US-NC-Western/Asheville; US-NC-Wilmington/Fayetteville; US-NC-Winston Salem; US-ND-Central; US-ND-Eastern; US-ND-Valley City; US-ND-Western; US-NH-Northern; US-NH-Southern; US-NJ-Central; US-NJ-Northern; US-NJ-Southern; US-NY-Albany/Poughkeepsie; US-NY-Binghamton/Elmira; US-NY-Buffalo; US-NY-Glens Falls; US-NY-Long Island; US-NY-New York City; US-NY-Northern; US-NY-Rochester/Pittsford; US-NY-Syracuse; US-NY-Utica; US-NY-Westchester; US-OH-Akron; US-OH-Cincinnati; US-OH-Cleveland; US-OH-Columbus/Zanesville; US-OH-Dayton; US-OH-Northwest; US-OH-Toledo; US-OH-Youngstown; 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-SC-South/Charleston; US-SD-East/Sioux Falls; US-SD-West/Rapid City; US-TN-Chattanooga; US-TN-Jackson; US-TN-Knoxville; US-TN-Memphis; US-TN-Nashville; US-VA-Charlottesville/Harrisonburg; US-VA-Fairfax; US-VA-McLean/Arlington; US-VA-Norfolk/Hampton Roads; US-VA-Northern; US-VA-Richmond; US-VA-Roanoke; US-VA-Vienna; US-VT-Northern; US-VT-Southern

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.

 

Manager l, Clinical Monitoring & Study Site Management (Oversight/advisor role) -Remote

 

About this role:

This is a position within the Interventional Cardiology (IC) Global Clinical Trials organization.

If you are a subject matter expert in clinical monitoring, and study site management in accordance with good clinical practices in the medical device arena and you want to make an impact to improve patients’ lives by bringing new therapies to market, this position is a unique opportunity for you to live your passion in a flexible/agile environment.  This person in this position can sit in our Marlboro, or Minnesota and/or remote (preferred eastern time and central time zone).

 

Key Responsibilities:

  • As the primary contact, you will interact with our internal and external partners responsible for study start-up, monitoring, and study site management (incl trial operations work). You will oversee and manage clinical functional work from our partners – in collaboration with clinical project management - through meaningful performance metrics, provide direction and guidance to ensure business commitments such as timelines, quality, and budget are met within the IC clinical portfolio / program level.
  • Reports to Director Clinical Operations Interventional Cardiology
  • This position has no direct reports
  • You will act as functional subject matter expert and advisor to :
  • The IC Global Clinical Trials organization as well as other functions and departments across BSC Clinical
  • Implement continuous improvement objectives of quality, simplification, efficiency, and cost control
  • Global initiatives workstreams to development of policies and procedures, implement global clinical systems (i.e. CTMS, eTMF, eConsent etc) and new regulations
  • In this role, you will interface and collaborate with other IC clinical functions, other functions, and departments across BSC Clinical organization.

 

What we are looking for:

Required Qualifications:

  • Bachelor’s-level degree in Life Science related fields such as Nursing, Pharmacy, Health Science
  • 8+ years of related work experience.
  • Minimum of 4+ years’ experience in monitoring / study site management in medical device industry
  • Minimum of 3+ years’ experience in direct or indirect management of monitoring, trial operations 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.
  • Experience in working with and/or overseeing work performance 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  
  • Experience in contributing or leading department / organizational initiatives with impact on process improvement and work efficiencies
  • Strong communication and presentation skills
  • Able to work independently and to solve complex problems
  • Approx. 10% travel 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 i.e., coronary therapy products, cardiac heart valves is preferred
  • 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 internal and external partners (CROs, global operations teams)

 

#LI-Reomote

 

Requisition ID: 534780

 

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.

 

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.


Nearest Major Market: Boston

Job Segment: Medical Device, Medical Research, Clinical Research, Travel Nurse, Clinic, Healthcare

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