Top 263536 Assoc Dir, Clinical Development Jobs

Clinical QA Specialist
XBiotech USA, Inc —Austin, TX
- Full-time
- Nursing
- 3 years
- Master's degree
- Health savings account
- Health insurance
Quick Apply
Director, Contracts and Budgets (Clinical Research)
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- 7 years
- Microsoft Excel
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8d
Clinical Trial Manager
Genmab —Princeton, NJ
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Rocket Pharmaceuticals —Cranbury, NJ
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CSL Behring —King of Prussia, PA
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Northwell Health —New York, NY
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Associate Director Clinical Development, Immunology
Biogen —Remote
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PSI CRO —Remote
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Associate/Senior Associate, Corporate Development
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Senior Director, Clinical Operations
Certara —Remote
- Full-time
- Microsoft Outlook
- Data analysis skills
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Senior Manager, Global Development Quality Assurance (GCP)
Regeneron —Remote
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Clinical Program Director of Health Technology Innovation - Remote
UnitedHealthcare —Minnetonka, MN
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Clinical Adjudication Manager (Part C)
TMF Health Quality Institute —Remote
- Weekends as needed
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Clinical Project Manager
Hematogenix Laboratory Sv —Tinley Park, IL
- Full-time
- Bachelor of Science
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- 2 years
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Director, Clinical Operations
Karoo Health —Remote
- Full-time
- Remote
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- 5 years
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Director, Clinical Quality
TScan Therapeutics —Waltham, MA
- $217,500 - $230,000 a year
- Full-time
- Hybrid work
- Senior level
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Clinical Quality Improvement Manager
St. Luke's Health System —Boise, ID
- Full-time
- 5 years
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Clinical Site Relationship Manager
IUVO BIOSCIENCE OPERATIONS, LLC —Remote
- $100,000 - $145,000 a year
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Senior Clinical Research Associate (Remote - Field Based)
Novartis —Remote
- $108,500 - $201,500 a year
- Full-time
- Remote
- 3 years
- Bachelor's degree
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- Health insurance
- 401(k) matching

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Clinical QA Specialist

XBiotech USA, Inc -
Austin, TX

Quick Apply

Job Details

Full-time

Benefits

Health savings account
Health insurance
Dental insurance
401(k)
Paid time off
Parental leave
Vision insurance
Life insurance

Qualifications

Regulatory inspections
Clinical research
Clinical research audit management
Quality control audit
Vendor compliance audits
Supplier audits
Clinical audit and monitoring
Bachelor's degree
Laboratory regulatory affairs
Attention to detail
Quality improvement
Vendor communication
Organizational skills
Training & development
Quality assurance experience within healthcare

Full Job Description

Job description:

XBiotech USA, Inc. is currently seeking an experienced Clinical Quality Assurance (QA) Specialist to join our team in Austin, TX.

XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development, and commercialization of therapeutic antibodies based on its True Human™ proprietary technology.

Unlike previous generations of antibody therapies, XBiotech’s True Human™ antibodies are 100 percent human, derived from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human™ antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy, and tolerability.

Position Summary:

The Clinical QA Specialist provides strategic QA oversight across clinical development programs of XBiotech, leverages expertise to ensure clinical research operations comply with regulatory standards (ICH-GCP, FDA, EMA, etc.) and internal policies, focusing on data integrity, patient safety and process improvements.

Key Responsibilities:

Compliance and Oversight:

· Develop and maintain the Quality Management System (QMS) and SOPs, to ensure compliance with Good Clinical Practice (GCP), and Good Laboratory Practices (GLP).

· Review and approve essential clinical trial documentation (protocols, reports, SOPs, etc.) for accuracy and compliance.

· Provide QA oversight for Phase I–III clinical trials, ensuring compliance with protocols, GCP, and applicable regulations throughout the trial lifecycle.

· Evaluate and manage protocol deviations and serious breaches in accordance with regulatory requirements.

· Collaborate with Clinical Operations, Data Management, Pharmacovigilance, and Regulatory Affairs to embed quality throughout clinical development.

CAPA and Risk Management:

· Manage the development, implementation and effectiveness of Corrective and Preventive Actions (CAPA).

· Perform root cause analysis for compliance issues. Conduct risk assessments and implement mitigation strategies.

· Track issues to resolution and trend data for systemic improvements.

· Proactively identify, report and mitigate risks within clinical research processes.

Audit and Inspection Readiness:

· Plan and execute QA audits of clinical trial sites, vendors, CROs, and internal processes.

· Conduct vendor qualification audits and ongoing oversight of third-party providers.

· Review and trend Audit Reports to propose process improvements.

· Prepare for and host regulatory inspections, ensuring all documentation is ready. Review audit findings and ensure timely resolution.

Training:

· Provide training on GCP and quality standards to staff and foster a culture of quality.

QUALIFICATIONS/EXPERIENCE REQUIRED:

· Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field. Master’s degree preferred.

· 5-7+ years of clinical research experience, including QA experience (3+ years) is required.

· Experience with regulatory inspections (FDA/EMA) preferred.

· Demonstrated experience planning and conducting clinical site and vendor audits, and hosting regulatory audits.

· Demonstrated competencies in GCP and regulatory compliance knowledge

· Proficiency with Electronic Data Capture (EDC) and eTMF systems.

· Excellent written and verbal communication skills.

· Must be a self-motivated and detail-oriented person who works well in a team setting.

· Must be willing to learn and adapt to changes in a fast-paced working environment.

·Must be able to multitask and have strong organizational skills.

Benefits:

401(k)
Dental insurance
Health insurance
Health savings account
Life insurance
Paid time off
Parental leave
Vision insurance

Education:

Bachelor's (Required)

Experience:

Clinical research: 5 years (Required)
QA: 3 years (Required)

Work Location: In person

Quick Apply

Refine Your Search

Assoc Dir, Clinical Development jobs

Clinical QA Specialist

Director, Contracts and Budgets (Clinical Research)

Clinical Trial Manager

Director, Clinical Operations - AAV

Director, Portfolio Development Process & Standards Lead

Clinical Professional Development Educator

Associate Director Clinical Development, Immunology

Clinical Operations Manager

Associate/Senior Associate, Corporate Development

Associate Director, Agios Clinical Educator, Sickle Cell Disease (West Zone)

Senior Director, Clinical Operations

Senior Manager, Global Development Quality Assurance (GCP)

Clinical Program Director of Health Technology Innovation - Remote

Clinical Adjudication Manager (Part C)

Clinical Project Manager

Director, Clinical Operations

Director, Clinical Quality

Clinical Quality Improvement Manager

Clinical Site Relationship Manager

Senior Clinical Research Associate (Remote - Field Based)

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