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Senior Clinical Quality Specialist
3 months ago
POSITION OVERVIEW:
Are you passionate about ensuring quality in clinical trials and making a difference in patients' lives? If so, this Senior Clinical Quality Specialist position may be the perfect fit for you
COMPANY INTRODUCTION:
NMDP/CIBMTR is a leading organization dedicated to advancing clinical trials with the goal of saving lives. Join us in our mission to drive quality and excellence in our clinical trial portfolio.
RESPONSIBILITIES:
- Lead the team in ensuring high-quality clinical trial operations daily.
- Collaborate closely with clinical trial managers and team members to promote a culture of quality-focused trial conduct.
- Oversee Document Management and Control processes efficiently.
- Manage the Corrective and Preventative Action (CAPA) system for clinical trial teams.
- Coordinate with NMDP Quality for internal audits and supplier qualifications.
- Conduct regular electronic Trial Master File audits.
- Act as a key resource for quality assurance and operational compliance for NMDP and CIBMTR teams.
- Stay updated on industry trends and proactively implement best practices for inspection readiness.
- Serve as the main contact for internal, regulatory, and investigator audits and participate as an auditor in internal and supplier audit teams.
- Conduct clinical site audits if required.
- Analyze data to identify trends and implement improvement strategies.
- Foster collaborative relationships with other departments.
- Assist in operational metrics reporting.
- Perform any other duties as assigned.
REQUIREMENTS:
Knowledge of:
- Comprehensive understanding of ICH Guidelines, GCP, and FDA regulations.
- Management of quality systems.
- Clinical trial development and execution process.
- Clinical operations and efficiencies.
Abilities:
- Work with a strong ethical mindset.
- Meet deadlines and handle multiple projects simultaneously.
- Communicate effectively and concisely.
- Take initiative, assess risks, and problem-solve.
- Provide effective teaching and mentoring.
- Must align with NMDP Standards.
Experience and Qualifications:
- Bachelor's degree required, preferably in a scientific or health-related field.
- At least 6 years of experience in clinical trials within the clinical/biotechnology sector.
- Minimum of 3 years in a clinical quality assurance role overseeing GCP compliance.
- Experience in reviewing and/or creating GCP-related documents such as SOPs and protocols.
PREFERRED QUALIFICATIONS:
(Additional qualifications that can enhance effectiveness in the position)
- Knowledge of cellular therapies and hematopoietic stem cell transplantation.
- Understanding of blood and tissue cancers and immune diseases.
COMMITMENT TO DIVERSITY, EQUITY, AND INCLUSION:
At NMDP, we value and embrace diversity, equity, and inclusion. We celebrate the unique abilities, backgrounds, orientations, and identities of our colleagues and provide a supportive environment for everyone's growth with us.
BENEFITS:
NMDP provides a comprehensive benefits package to full-time employees, including medical, dental, vision, life, disability, and other well-being benefits. Retirement plans, paid time off, holidays, leaves, and incentive programs are also available to eligible employees.
Join us in our mission to drive quality and excellence in clinical trials
