Clinical Operations Quality Manager

Hologic

3h•$116,500 - $182,200•Remote

About The Position

As a key member of the Breast and Skeletal Health (BSH) Clinical Affairs team, the Clinical Operations Quality Manager will oversee and execute major US-based and global clinical trials across multiple phases of product development, with a strong focus on quality oversight and quality assurance. You will work alongside a high-performing team of clinical development and operations experts to generate high-quality clinical evidence in support of innovative breast and skeletal health technologies. This role requires close collaboration with global regional teams and cross-functional partners, including Clinical Development, R&D, Program Management, Regulatory Affairs, Legal, Marketing, Service, and Operations. This position is ideal for a seasoned clinical operations professional with broad experience who can apply professional concepts and company objectives to resolve complex issues in creative and effective ways, while ensuring the highest standards of quality and compliance. This is a remote opportunity.

Requirements

Bachelor’s Degree required with 8+ years of relevant experience; or
Master’s Degree with 6+ years of experience; or
PhD with 3+ years of experience.
Experience running clinical trials and working for a sponsor or CRO in the medical device industry.
Experience developing and managing academic–industry partnerships.
Proven experience in the management of quality processes within clinical operations.
Strong track record in managing complex clinical studies and trials, ideally in medical devices.
In-depth understanding of quality processes and regulatory requirements in the medical device space, including GCP and ICH guidelines.
Demonstrated ability to conduct audits and quality checks, and to initiate and manage CAPA when required.
Excellent oral and written communication skills, including strong presentation skills and the ability to effectively represent and communicate the company’s position to internal and external stakeholders.
Proven interpersonal skills and success in a matrixed, cross-functional environment.
Strong organizational skills with the ability to multi-task, manage multiple projects, and adapt to changing priorities.
Strategic thinker with the ability to set and manage priorities and allocate resources effectively.
Collaborative, team-oriented mindset with a focus on achieving shared goals.

Nice To Haves

Clinical or research experience in breast cancer screening, diagnostics, and/or treatment domains strongly preferred.

Responsibilities

Lead the planning, execution, and oversight of clinical studies from start-up through close-out, ensuring trials are conducted according to established quality standards, protocols, and regulatory requirements.
Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory standards for clinical trials.
Critically review study-related documentation, including protocols, informed consent forms, site instructions, study manuals, eCRFs, data review plans, IRB submissions, IDE applications, and other trial documentation.
In collaboration with the Clinical team, select and manage CROs and other external vendors/consultants, including:
Contract and budget negotiation
Oversight of CRO activities from award through trial closeout
Oversee quality assurance and monitoring activities related to clinical trials.
Contribute to the creation, review, and maintenance of Standard Operating Procedures (SOPs) governing clinical operations activities.
Participate in the preparation of regulatory filings and support interactions with regulatory bodies, as needed.
Develop and implement processes and tools to improve the efficiency and effectiveness of clinical operations from a quality perspective.
Implement and maintain quality assurance processes, including audits, monitoring, and quality control checks.
Identify, manage, and resolve deviations from established quality standards and procedures; initiate and support CAPA as required.
Prepare reports on quality metrics and maintain accurate, timely documentation of quality-related activities in the Quality Management System (QMS).
Perform other function-related duties as required by business needs.