Clinical Quality Project Manager

bostonscientific•Maple Grove, MN

3d•Hybrid

About The Position

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: Assists the Clinical QA Manager in planning, coordinating, and executing clinical quality initiatives to ensure clinical activities are conducted in compliance with applicable regulatory requirements, quality standards, and internal procedures. This role is critical in ensuring the integrity of clinical research processes and the delivery of safe, effective solutions to patients worldwide. 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 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.

Requirements

Minimum of a bachelor's degree, or an associate's degree with a minimum of 3 years' professional experience.
Minimum of 3 years' experience in project management.
Minimum of 7 years' experience in clinical quality assurance, clinical research, or a related field within the medical device or pharmaceutical industry.
Experience working in FDA-regulated environments (medical devices, pharmaceuticals, or biologics).
Experience in either clinical or quality functions.
Strong knowledge of GCP, ISO standards, and global regulatory requirements related to clinical research.
Experience leading clinical quality projects and managing quality systems or initiatives.
Willingness to travel up to 20% domestically and/or internationally.
Strong knowledge of risk management processes and CAPA methodologies.
Excellent interpersonal and communication skills with the ability to work cross-functionally.
Ability to work independently and manage multiple priorities in a fast-paced environment.

Nice To Haves

Bachelor's degree with a minimum of 3 years' professional experience that includes project management.
Clinical quality experience.
Experience in pharmaceuticals and/or biologics in addition to medical devices.
Experience working with CROs and clinical vendors.
Prior experience supporting audits and regulatory inspections.
Experience in a matrixed, global organization.
Experience contributing to or reviewing clinical study documentation for quality and compliance.

Responsibilities

Manage and deliver clinical quality projects and initiatives in support of clinical programs and organizational quality objectives.
Plan, track, and report on project timelines, deliverables, risks, and dependencies to ensure on-time execution.
Partner with Clinical, Regulatory, and Quality stakeholders to ensure clinical activities comply with applicable regulations, standards, and internal procedures.
Provide clinical quality oversight and guidance throughout study planning, execution, and close-out phases.
Support implementation and maintenance of clinical quality systems, processes, and tools.
Lead quality risk management activities, including identification, assessment, mitigation, and documentation of clinical risks.
Support internal and external audits and regulatory inspections, including preparation, participation, and follow-up actions.
Drive investigation, root cause analysis, and CAPA activities related to clinical quality issues and deviations.
Monitor and analyze clinical quality metrics and trends; escalate issues and recommend continuous improvement actions.
Review and contribute to clinical documentation to ensure quality, compliance, and consistency with internal standards.
Facilitate cross-functional communication and alignment to resolve quality issues and support project goals.
Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.