POSITION SUMMARY:
Please apply online using a laptop or desktop computer.
The Senior Clinical Quality Specialist develops and implements quality systems and processes in support of NMDP/CIBMTR's prospective clinical trial portfolio. This role will lead clinical quality management. This position can be remote (US) or hybrid. #LI-Remote #LI-Hybrid
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ACCOUNTABILITIES:
- Responsible as team lead for day-to-day clinical quality oversight
- Proactively liaisons with clinical trial managers and team members to foster an environment of quality-oriented trial execution.
- Ensures efficient oversight and execution of Document Management and Control processes.
- Coordinates Corrective and Preventative Action (CAPA) system oversight for clinical trial team
- Coordinates with NMDP Quality for internal audit and supplier qualification
- Performs routine electronic Trial Master File audits.
- Serves as a lead resource to NMDP and CIBMTR quality teams regarding issues related to quality assurance and operational regulatory compliance.
- Monitors industry trends and engages with operational teams to proactively implement best practices and ensure inspection readiness.
- Clinical quality point of contact for internal, regulatory, and investigator audits and serves as an auditor on both internal audit and supplier audit teams.
- May perform for-cause clinical site audits, as necessary.
- Reviews data to identify trends and implements appropriate process improvement strategies.
- Fosters a collaborative working relationship with other functional areas.
- Supports operational metrics reporting.
- Other duties as assigned.
REQUIRED QUALIFICATIONS:Knowledge of: - Thorough understanding of ICH Guidelines, GCP, and FDA regulations.
- Quality systems management.
- Clinical study development and execution pathway.
- Clinical operations and efficiencies.
Ability to: - Operate with a high degree of ethics.
- Meet key deadlines and manage multiple projects and tasks simultaneously.
- Write and communicate articulately and concisely.
- Work proactively, take initiative and ownership, and assess risk.
- Provide strong teaching and mentoring skills.
- Problem-solve.
- Must exemplify our NMDP Standards.
Education and/or Experience: - Bachelor's degree required, preferred in scientific or health related field.
- Minimum 6 years of clinical trials experience in the clinical/biotechnology field.
- Minimum 3 years' experience in a clinical quality assurance position requiring oversight of GCP regulations.
- Experience with reviewing and/or drafting GCP related documents such as SOPs and protocols.
PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)
- Clinical knowledge of cellular therapies and/or hematopoietic stem cell transplant.
- Clinical knowledge of blood and tissue cancers; immune diseases.
DEI COMMITMENT: As part of our values, we are committed to supporting diversity, equity, and inclusion at NMDP. We actively celebrate colleagues' different abilities, sexual orientation, ethnicity, faith, and gender. Everyone is welcome and supported in their development at all stages in their journey with us.
BENEFITS: NMDP offers regular, full-time employees medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits. Retirement, paid time off/holidays, leave, and incentive plans are also offered to eligible employees. Please reference this link for more information: NMDP Benefit Information
