[Remote] Clinical Operations Quality Manager

Note: The job is a remote job and is open to candidates in USA. Hologic, Inc. is a leading company in breast and skeletal health technologies, and they are seeking a Clinical Operations Quality Manager to oversee and execute clinical trials. This role involves ensuring quality oversight and compliance in clinical studies while collaborating with cross-functional teams and external partners.

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

Skills

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

Benefits

• Competitive salary
• Annual bonus scheme
• Comprehensive training
• Continued development and training throughout your career

Company Overview

Company H1B Sponsorship