Job details

Clinical Quality Manager (ACRN) - Zimbabwe, Rwanda, South Africa , Tanzania

Location: Rwanda/ South Africa/ Tanzania/ Zimbabwe - On site at one of these locations

Hours: Full Time

Reports to: Chief of Staff/ Chief Medical Officer – Africa Clinical Research Network

Our Mission:

The African Clinical Research Network (ACRN) is an African-led and African-driven clinical research organisation. Our work not only promotes and supports a vibrant life sciences ecosystem but also profoundly impacts Africa's health and economic development. By facilitating sustainable, innovative, collaborative, and community-oriented research, ACRN is poised to transform healthcare and improve lives across Africa, inspiring a new era of clinical research.

We provide high-quality data, harmonise regulatory processes to improve timelines, support capacity building within the existing ethics and regulatory systems, and enhance community trust and research participation. These are some of the first key steps to making Africa more competitive in the global life sciences industry, a goal we are proud to contribute to.

The ACRN drives clinical research excellence by connecting researchers to opportunities, enhancing research capacity in existing facilities, implementing high-quality trials and research, and leveraging a robust digital infrastructure.

We are committed to fostering the community's understanding of research. Through our community engagement network, we significantly increase stakeholder buy-in of clinical results, thereby enhancing the transparency and credibility of our research.

Job Summary:

The Quality Manager is integral to maintaining the integrity and quality of clinical trials within the organization. This role is responsible for ensuring that all clinical studies are conducted in compliance with Good Clinical Practice (GCP), regulatory requirements, and organizational standards. The Quality Manager will work collaboratively with clinical operations, regulatory affairs, and quality assurance teams to drive continuous improvement and implement effective quality management systems.

Key Responsibilities:

Quality Oversight:

Develop and maintain a comprehensive quality management plan for clinical trials to ensure adherence to GCP and regulatory guidelines.

Conduct regular risk assessments and quality checks throughout the clinical trial lifecycle to identify and address potential issues proactively.

Regulatory Compliance:

Stay abreast of relevant regulations and guidelines from authorities such as the FDA, EMA, and ICH, and ensure the organization’s compliance with these standards.

Review and approve regulatory submissions and documentation related to clinical trials.

Audit and Inspection Management:

Lead internal and external audits for clinical trials, coordinating the preparation of materials and responses to findings.

Support regulatory inspections, ensuring all necessary documentation is available and that teams are adequately prepared.

Training and Development:

Design and implement training programs for clinical staff on quality management practices, GCP requirements, and regulatory compliance.

Mentor and support clinical trial teams in maintaining quality standards and addressing quality-related issues.

Process Improvement:

Identify opportunities for process optimization and efficiency improvements in clinical trial management.

Collaborate with cross-functional teams to develop and implement standard operating procedures (SOPs) that enhance operational quality.

Stakeholder Engagement:

Act as the primary contact for quality-related inquiries from sponsors, regulatory bodies, and internal stakeholders.

Build and maintain strong relationships with external partners to promote a culture of quality.

Reporting and Metrics:

Develop and maintain quality metrics and dashboards to monitor the performance of clinical trials.

Provide regular reports to senior leadership on quality issues, risk management, and regulatory compliance status.

Quality Issue Resolution:

Actively facilitate the identification and resolution of quality issues in clinical trials, implementing corrective and preventive actions (CAPA) as necessary.

Ensure thorough documentation of quality events and compliance with industry best practices.

Qualifications:

Education: Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field; post-graduate degree preferred.

Experience: 5+ years of experience in clinical research with a focus on quality assurance or clinical trial management.

Desired Attributes and Knowledge : In-depth understanding of ICH GCP guidelines, and regulatory requirements for clinical trials.

Skills and Competencies: Strong analytical, problem-solving, and decision-making skills. Excellent written and verbal communication abilities. Proficient in quality management systems and audit processes.

Work Environment:

This position can be based in Zimbabwe, Rwanda, Tanzania or South Africa, with occasional travel to other office locations as necessary. The role may require flexible working hours to support remote teams and ensure systems are running smoothly across time zones.

Please apply online providing a covering letter specifically highlighting how your existing skills and experiences support fulfilling the responsibilities of this role.

What You Should Know About Clinical Quality Manager (ACRN) - Zimbabwe, Rwanda, South Africa , Tanzania, Ellison Institute of Technology

If you're passionate about clinical research and are looking for an exciting opportunity, the African Clinical Research Network (ACRN) is seeking a Clinical Quality Manager to join their dynamic team in Zimbabwe, Rwanda, South Africa, or Tanzania. In this full-time role, you will play a vital part in ensuring that all clinical trials adhere to Good Clinical Practices (GCP) and regulatory requirements. Your expertise will help maintain the integrity and quality of trials, propelling ACRN's mission to enhance healthcare across Africa. You'll collaborate closely with various teams, driving continuous improvement and quality management systems while developing comprehensive quality management plans for clinical trials. This means you'll regularly conduct risk assessments, lead audits, and manage regulatory compliance to uphold high standards. Your role is not just about overseeing quality, but also about training and mentoring clinical staff to ensure they have the skills necessary to excel. As ACRN focuses on building community trust and enhancing research participation, you'll also engage stakeholders and facilitate open communication on quality issues. It’s a challenging position that requires at least five years of experience in clinical research, along with strong analytical and communication skills. If you have a Bachelor's degree in a related field and a deep understanding of ICH GCP guidelines, you might just be the perfect fit. Join ACRN, where your efforts will contribute to a healthier future for Africa and possibly improve lives across the continent.

Frequently Asked Questions (FAQs) for Clinical Quality Manager (ACRN) - Zimbabwe, Rwanda, South Africa , Tanzania Role at Ellison Institute of Technology

What are the key responsibilities of the Clinical Quality Manager at African Clinical Research Network?

The Clinical Quality Manager at ACRN is responsible for overseeing the quality of clinical trials, ensuring compliance with Good Clinical Practices (GCP) and regulatory standards. Key responsibilities include developing quality management plans, conducting risk assessments and quality checks, managing audits and inspections, training clinical staff, identifying process improvements, and reporting on quality metrics to senior leadership.