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Clinical Operations Quality Manager

Connexion Systems + Engineering

REMOTE, MA(remote)

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JOB DETAILS
SALARY
$140,000–$150,000 Per Year
SKILLS
Auditing, Breast Cancer, Budgeting, Case Report Form (CRF), Clinical Practices/Protocols, Clinical Research, Clinical Support, Clinical Trial, Communication Skills, Contract Negotiation, Contract Research Organization (CRO), Corporate Communications, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, D Programming Language, Documentation, Drug Development, Establish Priorities, GCP (Good Clinical Practices), Healthcare Quality, IDE (Integrated Development Environment), IRB/IEC (Institutional Review Board/Independent Ethics Committee), Informed Consent, Interpersonal Skills, Legal, Maintain Compliance, Marketing, Medical Equipment, Multitasking, Operational Strategy, Operations Management, Operations Processes, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Process Management, Product Development, Project/Program Management, Quality Assurance, Quality Assurance Methodology, Quality Control, Quality Management, Quality Metrics, Quality Monitoring, Regulations, Regulatory Requirements, Regulatory Submissions, Reporting Skills, Research & Development (R&D), Resource Management, Standard Operating Procedures (SOP), Startup, Team Player, Time Management, Writing Skills
LOCATION
REMOTE, MA
POSTED
26 days ago
Job Title: Clinical Operations Quality Manager
Salary: $140-150k ($120k - $180K range) + 10% bonus
Location: REMOTE
Duration: PERM

Job Description:
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. 
Key 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.
Qualifications (Education & Experience):
  • 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.
Skills & Competencies:
  • Strong track record in managing complex clinical studies and trials, ideally in medical devices.
  • Clinical or research experience in breast cancer screening, diagnostics, and/or treatment domains strongly preferred.
  • 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.

About the Company

C

Connexion Systems + Engineering

Connexion is an award-winning professional staffing firm that strives to be the unrivaled staffing solution for job seekers by expertly connecting talent with opportunity.  Over the last 20 years Connexion has built the most admired team of staffing experts in the industry.  We give back, change lives and offer unconditional support to the candidates we represent.

Put Connexion's 20 years of experience to work for you! Our professionals have unrivaled relationships and contacts with the hiring managers, human resources team and decision makers at the most desirable companies to work for.

Don't let your resume get lost in an inbox, Connexion's recruiting team will advocate on your behalf to get you the job you want

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1999
WEBSITE
https://www.csetalent.com/

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