Boston Scientific Clinical Trial Manager 

United States, Minnesota, Arden Hills 

858215404

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

This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Arden Hills or 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.
• Provides clinical input for new product development, post -market surveillance, recertification,and business development
• Interacts with various study support groups in order 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 meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to functions, core teams and senior leadership
• 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 IFUs and authorship of Clinical Evaluation documents (CES, CRBA, CDSR) for identification of harms and support of safety performance for product approval

Required qualifications:

• Minimum Bachelor’s degree and 7 years of related work experience or an equivalent combination of education and work experience
• Minimum 5 years of Clinical Trial Management Experience
• Proven experience working with external vendors and Contract Research Organizations (CRO)
• Availability for up to 10% travel

Preferred qualifications:

• Proven experience with investigational device clinical trials
• Proven experience with Electrophysiology cardiology
• Ability to use in-depth knowledge of business unit functions and cross-functional group dependencies/relationships
• Ability to apply comprehensive technical knowledge of Electrophysiology Cardiology 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
  

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.