Clinical Project Manager (Acrn) - Zimbabwe, South Africa, Rwanda, Tanzania

Location: Zimbabwe, South Africa, Rwanda, Tanzania

Hours: Full-Time

Reports to: Head of Clinical Operations - 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 Project Manager (PM) is tasked with overseeing the execution of ACRN studies. Acting as the main point of contact between the ACRN study team and the Sponsor teams, the PM leads cross-functional teams throughout the entire project lifecycle, from study initiation to completion. This role is responsible for managing clinical studies and ensuring that all project deliverables meet the sponsor's expectations, maintaining high-quality outputs that are delivered on schedule and within budget, while adhering to Standard Operating Procedures (SOPs) and relevant regulations. The position requires managing teams across various locations and cultivating strong relationships with sponsors, regulatory agencies, and other key stakeholders.

Key Responsibilities:

1. Development of clinical trial capability: Support site identification, assessment and development of capability to support existing and new clinical projects and studies. Provide clinical operation expertise to the planning and set-up of Southern African clinical trial sites and laboratory networks for new projects and studies.
2. Project Delivery: Coordinate the planning, initiation, execution, monitoring, and closure of clinical projects across multiple countries. Ensure projects are delivered on time, within scope, and on budget while meeting regulatory and ethical standards.
3. Team Management: Train and mentor a high-performing allocated study team members. Provide leadership and guidance to project managers, fostering collaboration and accountability.
4. Stakeholder Engagement: Act as the primary point of contact for sponsors, ensuring alignment of project goals and expectations. Build and maintain strong relationships with regulatory authorities, ethics committees, and other stakeholders.
5. Ensure regulatory compliance for projects: Be familiar with drug development regulatory requirements, documentation and processes for major international agencies and have thorough knowledge of the clinical development process. Participate in preparation and submission of regulatory documentation for allocated countries.
6. Risk and Issue Management: Identify, assess, and manage risks and issues that may impact project delivery. Develop and implement contingency plans to address challenges effectively.
7. Compliance and Quality Assurance: Ensure that all clinical projects comply with Good Clinical Practice (GCP), regulatory guidelines, and organizational policies. Prepare and review clinical SOPs and other standard documents required for clinical trials. Collaborate with quality assurance teams to conduct audits and implement corrective actions as needed.
8. Reporting and Metrics: Develop and maintain project dashboards, providing regular updates on project status, risks, and milestones to senior leadership. Ensure accurate documentation and reporting for regulatory and sponsor requirements.
9. Innovation and Continuous Improvement: Promote a culture of innovation and continuous improvement in project management practices. Explore and implement technologies to enhance project management efficiency.

Requirements

Qualifications:

Education: Bachelor's degree in life sciences, healthcare, or a related field. A Master's degree or equivalent in project management or clinical research is highly preferred.

Experience: Five or more years of clinical operations experience (preferably global project management experience within a CRO or pharmaceutical environment). Proven track record of managing complex, multi-country clinical research projects. Strong knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and regulatory requirements.

Skills and Competencies:

Exceptional leadership and team management skills. Proficiency in project management tools and software such as MS Project, Smartsheet, or equivalent. Excellent communication, negotiation, and stakeholder management skills. Fluency in English is required; proficiency in other African languages is an advantage.

Desired Attributes:

Strategic thinking and problem-solving. Leadership and team-building. Strong organizational and multitasking abilities. High attention to detail and commitment to quality. Cultural sensitivity and adaptability.

Working Environment:

This position is based in either Zimbabwe, South Africa, Rwanda, or Tanzania 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.