Clinical Trial Operations Specialist II

Boston Scientific; Maple Grove (MN); Hybrid; USD 68,000 - 129,000; Full time

Job summary

Boston Scientific is seeking a Clinical Trial Operations Specialist II to support global clinical studies in urology, neuromodulation, pelvic floor disorders, and related areas. You will collaborate with multidisciplinary teams to plan, execute, and oversee trials ensuring safety, effectiveness, and regulatory compliance.

The role requires a Bachelor's degree in a life sciences field and 2+ years of clinical research experience, with strong project management and documentation skills.

Qualifications

• Bachelor's degree required in a life sciences or related field with minimum 2 years clinical research experience.
• Experience coordinating with multiple stakeholders to meet timelines and deadlines.
• Strong written and verbal communication and ability to maintain audit-ready documentation.

Responsibilities

• Support the project team in planning, executing, and managing operational aspects of global clinical trials.
• Participate with supervision in the execution of clinical studies in accordance with project plans, budgets and resource allocations.
• Track the development of project materials and collaborate with cross-functional team members on study materials, processes, manuals, plans, committees, and study systems.
• Support sponsor regulatory submissions as applicable and maintain documentation to support audit readiness.
• Collaborate with stakeholders to identify, assess, and manage clinical study risks.

Skills

Project management

Microsoft Office

Written communication

Verbal communication

Documentation & tracking

Education

Bachelor's degree in biology/life sciences/ nursing/ biomedical engineering/ public health/ clinical research

Tools

Trial Master File (TMF)

EDC

CTMS

eTMF

Job description

Additional Location(s): US-MA-Marlborough; US-MN-Maple GroveDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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:Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.At Boston Scientific Urology, we are committed to developing innovative technologies that improve the lives of patients with urologic and pelvic health conditions. As a Clinical Trial Operations Specialist II, you will support clinical research programs that generate the evidence needed to advance therapies across areas such as neuromodulation, pelvic floor disorders, stone management, benign prostatic hyperplasia, and prosthetic urology.In this role, you will work closely with cross-functional teams to support the planning, execution, and oversight of global clinical studies that evaluate the safety, effectiveness, and real-world impact of innovative medical technologies. This position offers an excellent opportunity to build foundational clinical research expertise while contributing to evidence generation that informs regulatory submissions, scientific publications, healthcare provider education, and patient access to life-changing therapiesWork model, sponsorship, relocation:At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office Maple Grove, MN or Marlborough, MA at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.Your responsibilities will include:Support the project team in planning, executing, and managing operational aspects of global clinical trials.Participate with supervision, in the execution of clinical studies in accordance with project plans, budgets and resource allocations while following applicable regulatory requirements and standard operating procedures.Track the development of project materials and collaborate with cross-functional team members on internal and external study materials, processes, manuals, plans, committees, and study systems.Support-required sponsor regulatory submissions, as applicable.Maintain documentation and processes that support a continuous state of audit readiness.Collaborate with the project team to identify, assess, and manage clinical study risks.Partner effectively with departmental and cross-functional stakeholders to support clinical study and program objectives.Required qualifications:Minimum bachelor's degree in biology, life sciences, nursing, biomedical engineering, public health, clinical research, or related field and 2 years of clinical research experience, for example, Clinical Research Coordinator, Clinical Trial Assistant, Clinical Operations Associate, Research Assistant, Regulatory Coordinator, or internship/co-op in clinical research.Basic understanding of clinical research or healthcare environment.Experience working with multiple stakeholders to complete projects, coordinate activities, and meet established timelines.Demonstrated ability to organize and maintain project documentation, track deadlines, follow up on action items, and manage multiple assigned tasks simultaneously.Ability to work within established procedures, project plans, and quality requirements.Strong written and verbal communication skills.Strong project management skills and experienced with Microsoft Office SuiteDemonstrated knowledge of Trial Master Files and essential clinical and regulatory documentsPreferred qualifications:Proven experience supporting clinical studies, clinical research or clinical trial operations, especially in medical devicesWorking knowledge of Good Clinical Practice (GCP) principles; familiarity with ICH-GCP, ISO 14155, and applicable FDA clinical research regulations preferred.Exposure to EDC, CTMS, eTMF or electronic medical recordsFamiliarity with clinical study documentation, study systems, and regulatory processes.Understanding clinical research quality requirements and audit-readiness practices.Experience supporting global or cross-functional projects preferred.Preferred Association of Clinical Research Professionals (ACRP) accreditation.Requisition ID: 633925Minimum Salary: $ 68100Maximum Salary: $ 129400The 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.Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.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 identity, 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.