Additional Location(s): US-MA-Marlborough; US-MN-Maple Grove
About the role: 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 therapies
Work 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 Suite
- Demonstrated knowledge of Trial Master Files and essential clinical and regulatory documents
Preferred qualifications: - Proven experience supporting clinical studies, clinical research or clinical trial operations, especially in medical devices
- Working 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 records
- Familiarity 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: $ 68100 Maximum Salary: $ 129400 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.
