Clinical Trial Operations Specialist II

Boston Scientific•Maple Grove, MA

9d•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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.

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 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.