Clinical Operations Manager (ACRN) - Based Zimbabwe or South Africa

Location: Zimbabwe, South Africa 

Hours: Full- Time 

Reports to: Head of Clinical Operations  

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 Clinical Operations Manager (COM) is s responsible for overseeing the CRA team and ensuring the successful execution of clinical trials. Acting as a key leader within the clinical operations department, the COM will coordinate activities related to site monitoring, compliance, and quality assurance. This role involves managing personnel, developing training programs, and fostering professional development of CRAs. The COM ensures that all projects are conducted in accordance with Good Clinical Practice (GCP) and relevant regulatory guidelines, while delivering high-quality data and results. 

Key Responsibilities: 

Team Leadership and Management: 

Lead, mentor, and manage a team of Clinical Research Associates, providing guidance on best practices in site monitoring and compliance. 

Conduct performance evaluations, facilitate professional development, and support career growth for team members. 

Training and Development: 

Develop and implement training programs for new and existing CRAs, ensuring they are equipped with the necessary skills and knowledge. 

Organize workshops and seminars to promote continuous learning and keep the team updated on industry trends and regulatory changes. 

Project Management: 

Collaborate with project managers to ensure that clinical trials are executed on time and within budget. 

Monitor CRA deliverables, providing regular updates to senior management. 

Quality Assurance and Compliance: 

Ensure that all monitoring activities are conducted in accordance with internal SOPs, GCP, and applicable regulations. 

Participate in internal and external audits and inspections, addressing findings and implementing/oversee corrective actions as necessary. 

Reporting and Documentation: 

Prepare and review monitoring reports, ensuring compliance to ACRN SOPs by CRAs. 

Maintain oversight of essential documents and ensure proper filing and organization within the Trial Master File (TMF). 

Qualifications: 

Education: Bachelor’s degree in life sciences, nursing, pharmacy, or a related field; a Master’s degree is preferred. 

Experience: Minimum of 5 years’ experience in clinical operations is mandatory. Experience in quality assurance within a pharmaceutical, biotechnology company or clinical research organisation is an advantage.  

Working Environment: 

This position is based in either Zimbabwe or South Africa with extensive travel to sites in-country and to other countries on the African continent. 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.