Senior Clinical Trial Manager

Additional Location(s): US-MN-Arden Hills; US-MA-Cambridge; US-MA-Lexington; US-MA-Lowell; US-MA-Marlborough; US-MA-Natick; US-MA-Quincy; US-MA-Western/Springfield; US-MA-Worcester; US-MN-Mankato/Rochester; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Minnetonka; US-MN-Plymouth

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: 
The Senior Clinical Trial Manager will be responsible for the design, planning, execution and leadership of clinical  studies and clinical programs worldwide for our Watchman portfolio.  This role is responsible for leading cross functional clinical teams in support of the organization's business objectives for product development and/or  commercialization. This incumbent possesses a technical knowledge of products, processes, and regulatory requirements for  clinical trials conducted within a given therapeutic area.  
 

This is a hybrid position (in office minimum three days per week) with the flexibility to be in Maple Grove, MN or Marlborough, MA. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.
  
Your responsibilities will include: 

• Writes study protocols, protocol amendments, informed consents, clinical study project timelines and scientific  papers for publication by evaluating scientific literature and publications, analyzing scientific data and staying  abreast of current clinical practice.  Efforts and leadership will support product approval, indication expansion and claim support, and mandated post market requirements. 
• Leads the development of clinical strategy and trial design by conducting meetings with the appropriate  departments and individuals to obtain feedback/direction. Provides project leadership and scientific expertise  throughout the development and implementation of local or global clinical studies. May lead studies executed  by a CRO. 
• Provides clinical input for new product development, post market surveillance, recertification, and business development. 
• Interacts with various study support groups to assist in clinical strategy, the development of study plans, and  project deliverables. Interacts with regulatory agencies as needed and will use their scientific knowledge in order  to provide directives to staff as well as study sites. 
• Facilitates communication between Sales and Marketing, R&D, Regulatory Affairs, Training, Senior Management,  Key Opinion Leaders/investigators, and investigational sites by conducting team meetings, drafting and sending  routine correspondence (e.g., newsletters) and by presenting regular updates to senior staff. 
• Manages clinical study timelines, budget by utilizing the appropriate project management tools, selecting  providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines. 
• Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. 
• Presents scientific data by communicating accurate, succinct summaries of clinical study work at industry  gatherings, investigational meetings and regulatory agency meetings. 
• Provides accurate progress reports on clinical projects by writing assigned clinical portions of reports for  submission to regulatory agencies, Institutional Review Boards, Medical Ethics Committees, etc. May include  clinical risk management activities including input into Hazard Analyses, product FMEA and DFUs and  authorship of Clinical Evaluation documents (CES, CRBA, CDSR) for identification of harms and support of safety performance for product approval. 

  
Required qualifications: 

• Minimum of a Bachelor’s degree or equivalent experience needed
• Minimum of relevant and related 8 years of work experience or an equivalent combination of education and work  experience. 
• Minimum of 5 years of Clinical and trial experience required  

 
Preferred qualifications: 

• Ability to use in-depth knowledge of business unit functions and cross-functional group dependencies/ relationships 
• Ability to apply comprehensive technical knowledge of Cardiology and/or Electrophysiology to resolve complex  issues in creative ways 
• Preference for a professional with a wide range of experience and expertise in a specialized technical or scientific field 
• Proven experience working with external vendors and Contract Research Organizations (CRO)

Requisition ID: 602188 

Minimum Salary: $ 122100 

Maximum Salary: $ 232000 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.