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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. 

 

What You Should Know About Clinical Operations Manager (ACRN) - Based Zimbabwe or South Africa, Ellison Institute of Technology

At the African Clinical Research Network (ACRN), we're on a mission to transform healthcare across Africa, and we're looking for a passionate Clinical Operations Manager to join our team based in Zimbabwe or South Africa. In this full-time role, you'll be at the helm, leading and mentoring a dedicated team of Clinical Research Associates (CRAs) to ensure the successful execution of clinical trials. Your leadership will guide site monitoring, ensure compliance with industry standards, and uphold the integrity of our quality assurance processes. We believe in empowering our team, so you'll be developing training programs and facilitating workshops to keep everyone ahead of the curve in clinical research. With a firm commitment to Good Clinical Practice (GCP) and a keen eye for detail, you'll ensure every project runs smoothly, on time, and within budget. At ACRN, your efforts will directly impact the life sciences ecosystem in Africa, enhancing our community's understanding of research and building trust among stakeholders. If you’re enthusiastic about leading clinical research excellence and making a real difference in the lives of many, we want to hear from you!

Frequently Asked Questions (FAQs) for Clinical Operations Manager (ACRN) - Based Zimbabwe or South Africa Role at Ellison Institute of Technology
What are the main responsibilities of a Clinical Operations Manager at ACRN?

As a Clinical Operations Manager at the African Clinical Research Network, your main responsibilities include overseeing the CRA team, ensuring clinical trials are executed with the highest standards of quality, and compliance with Good Clinical Practice (GCP). You will mentor team members, develop training programs, and coordinate project management processes to deliver timely and accurate results.

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What qualifications are required for a Clinical Operations Manager at ACRN?

To qualify for the Clinical Operations Manager role at the African Clinical Research Network, you should hold a Bachelor's degree in life sciences, nursing, pharmacy, or a related field, with a preference for a Master's degree. Additionally, a minimum of 5 years of experience in clinical operations and a background in quality assurance in a clinical research setting is essential.

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How does the Clinical Operations Manager enhance team performance at ACRN?

The Clinical Operations Manager enhances team performance at ACRN by providing leadership and mentorship, conducting performance evaluations, and facilitating professional development programs for Clinical Research Associates. By organizing continuous learning workshops, you’ll ensure the team remains informed of the latest regulatory changes and industry trends.

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What is the working environment like for a Clinical Operations Manager at ACRN?

The working environment for a Clinical Operations Manager at the African Clinical Research Network is both dynamic and engaging as it involves extensive travel throughout Zimbabwe and South Africa, and potentially other African countries. The role may require flexible working hours to coordinate effectively with remote teams across different time zones.

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What impact does the Clinical Operations Manager have on healthcare in Africa?

The Clinical Operations Manager at ACRN plays a pivotal role in enhancing the quality and credibility of clinical research in Africa. By ensuring rigorous monitoring and compliance with regulatory standards, you contribute to the delivery of reliable data that shapes healthcare policies, ultimately improving health outcomes and fostering economic development in the region.

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Common Interview Questions for Clinical Operations Manager (ACRN) - Based Zimbabwe or South Africa
Can you describe your experience managing clinical trials and the role of a Clinical Operations Manager?

When answering this question, emphasize your relevant experience by discussing specific projects you've managed. Highlight your leadership abilities, knowledge of GCP, and how you’ve ensured compliance and quality in previous roles to deliver successful clinical trials.

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How do you approach training and developing team members in a clinical operations environment?

Discuss your strategies for mentoring and training team members. Mention how you assess their training needs, develop tailored programs, and the importance of continuous learning in clinical research to keep your team updated on best practices.

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What techniques do you use to ensure adherence to Good Clinical Practice in your projects?

Share your methods for maintaining compliance with GCP such as conducting regular audits, providing training workshops, and implementing standard operating procedures. Provide examples of how you’ve addressed compliance challenges in past roles.

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How do you handle conflicts or challenges within your team?

Discuss your conflict resolution skills by giving examples of past conflicts you've managed. Highlight your approach to open communication, collaboration, and problem-solving to maintain a positive team environment.

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What tools or systems have you used to manage clinical trial data and documentation?

Detail your experience with specific tools for managing data and documentation in clinical trials. Discuss how these systems help maintain compliance, enhance data quality, and streamline reporting processes.

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How do you prioritize tasks and manage time effectively in a fast-paced clinical operations environment?

Provide insight into your time management strategies, discussing how you prioritize tasks based on deadlines and project goals. Mention your use of project management tools and how you've balanced multiple projects successfully.

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Can you provide an example of a successful project you've managed and the results you achieved?

When answering, narrate a specific project emphasizing your role in its success. Discuss the challenges faced, methodologies employed, and the positive outcomes resulting from your leadership.

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What do you think is the most important quality for a Clinical Operations Manager?

Share your insights on key qualities such as leadership, communication, attention to detail, and adaptability. Discuss why these attributes are crucial for success in managing clinical operations.

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How do you ensure stakeholder engagement in clinical research projects?

Discuss your strategies for stakeholder engagement such as regular communication, transparency in reporting, and involving key stakeholders in the research process to foster trust and collaboration.

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What methods do you use to stay updated on regulatory changes within the clinical research field?

Explain your strategies for staying informed about regulatory changes, such as participating in professional networks, attending industry conferences, and subscribing to relevant publications to ensure continuous learning and compliance.

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Full-time, remote
DATE POSTED
January 12, 2025

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