Quality Manager | Clinical Research Operations (JB4805)
Remote, for applicants living in South Africa
Market-Related
Duration: Permanent
We are seeking a highly skilled Quality Manager with expertise in clinical research operations to uphold and enhance the quality of our client's clinical trials. The ideal candidate will have a background as a Clinical Research Associate (CRA) with experience in pharmaceutical companies or Contract Research Organizations (CROs). This role will involve working closely with clinical operations and regulatory teams to ensure compliance with Good Clinical Practice (GCP) and relevant industry standards.
This is a remote-based position with occasional travel to clinical trial sites and partner locations.
Minimum Requirements:
Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field (required).
Advanced degree (Master's or PhD) or equivalent experience in clinical research or pharmaceutical quality management (preferred).
Minimum of 5 years of experience in clinical research, focusing on quality assurance or quality management.
Experience as a CRA, ideally within a pharmaceutical company or CRO.
Strong familiarity with Good Clinical Practice (GCP), ICH guidelines, and regulatory compliance standards.
Proven experience auditing clinical trial sites and implementing corrective actions.
Strong communication, analytical, and problem-solving skills.
Ability to work collaboratively in cross-functional teams.
Duties and Responsibilities:
Clinical Trial Quality Oversight:
Implement and manage the quality management system (QMS) within clinical operations.
Ensure adherence to GCP, Standard Operating Procedures (SOPs), and regulatory requirements.
Oversee data quality from clinical trials, ensuring accuracy and consistency.
Conduct quality control audits of trial sites, identifying gaps and recommending corrective actions.
Compliance and Regulatory Management:
Ensure compliance with local and international regulatory standards (ICH-GCP, FDA).
Collaborate with regulatory bodies, ensuring proper documentation of clinical research activities.
Provide guidance on quality and compliance issues to research teams and senior management.
Process Improvement and Risk Management:
Identify risks in clinical trial processes and develop mitigation strategies.
Lead initiatives to improve process efficiency and maintain high-quality standards.
Conduct root cause analysis and implement corrective and preventive actions (CAPA).
Training and Development:
Develop and deliver quality assurance training for clinical staff.
Ensure team members are updated on regulatory changes and quality standards.
Mentor junior staff, especially CRAs, in quality assurance practices.
Collaboration with Key Stakeholders:
Coordinate with clinical operations, data management, regulatory affairs, and project management teams.
Collaborate with external partners to ensure outsourced research adheres to quality standards.
Audit Preparation and Reporting:
Lead internal and external audits, including sponsor audits and regulatory inspections.
Present audit reports, quality metrics, and compliance findings to senior management.
Address audit findings with timely corrective actions.
Please do not apply using Scanned CVs, no supporting documentation is required at this point, this will be requested later.
IMPORTANT: We specialize in specific niche fields. Regret that we are unable to provide assistance for any fields outside of this scope. Fields can be viewed on our website.
Kontak Recruitment Disclaimer:
Equal opportunity: All backgrounds are welcomed, with no bias. All are considered based on requirements.
Job specifics: Requirements mirror advertisement, duties may adjust for client needs.
Fair process: Fair assessment, only shortlisted candidates contacted due to volume.
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