Clinical Trial Quality Assurance (QA) Manager

Position Summary:

The Clinical Trial Quality Assurance (QA) Manager is responsible for implementation and oversight of quality management activities for all clinical trials conducted at UNC Clinical Research Sites in Vietnam, ensuring compliance with regulatory requirements, protocol, and sponsor guidelines.

Main Duties & Responsibilities:

1. Develop and Maintain the Clinical Quality Management Plan (CQMP)

• Establish and implement standard operating procedures (SOPs) for Quality Management System

• Manage, update, and control the documentation of SOPs related to all phases of clinical trials from start to finish.

• Develop and manage the quality-controlled documentation system, including forms, work instructions, and related records.

• Ensure SOPs are disseminated, trained on, and adhered to by all relevant parties.

2. Auditing

• Plan and conduct regular internal audits at research site to assess compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.

• Perform audits of vendors management.

• Monitor and verify the implementation of Corrective and Preventive Action (CAPA) to ensure issues are fully resolved.

3. Quality Assurance (QA)

• Review key study documents, such as IRB submission, CAPA reports, and other materials before presenting them to In-Country Director to ensure accuracy and completeness.

• Collaborate with other functional teams (e.g., Clinical Operations, Data Management, Laboratory, Pharmacy) to identify and address potential quality issues.

• Conduct periodic reviews to ensure compliance with regulations related to study data and records.

4. Risk Management and Training

• Identify, assess, and manage quality-related risks during the clinical trial process.

• Design and implement GCP training programs for internal staff and research site personnel to enhance awareness and compliance.

• Stay updated on new legal regulations and health authority guidelines (e.g., Department of Drug Administration, Ministry of Health, National Institute of Health) to ensure the system remains compliant.

5. Regulatory Inspections

• Support the In-country Director in preparing for and supporting inspections from regulatory bodies.

• Support the In-country Director in representing clinical activities during inspections to present and defend records and procedures.

• Support the In-country Director in coordinating the handling of inspection findings and developing site responses.

Required qualifications and skills:

• Education: Master’s degree in clinical research, Biomedical Science, Health Science, Public Health, Pharmacy or related field

• Experience:

• At least 3-5 years of experience in clinical research or quality assurance (QA) within the pharmaceutical or biotechnology industry.

• Experience in conducting clinical trial audits according to GCP standards is a significant advantage.

• Skills:

• Strong analytical, problem-solving, and independent decision-making skills.

• Excellent communication, negotiation, and presentation skills.

• Ability to work independently and as part of a team effectively.

• Proficiency in English (listening, speaking, reading, writing) to work with international documents and partners.