Investigational Product (IP) and Logistics Manager (ACRN) - Zimbabwe

Location: Harare, Zimbabwe 

Hours: Full Time 

Reports to: Chief of Staff – 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 Investigational Product (IP) and Logistics Manager will oversee the comprehensive management of investigational products (IP), including supply chain coordination, manufacturing requirements, labeling, stability testing, and compliance with global regulatory standards. This role is integral to ensuring the smooth and compliant execution of clinical trials at ACRN sites. Additionally, the manager will evaluate site pharmacies, develop their capacity for clinical research, and train site pharmacists to become proficient research pharmacists capable of managing investigational products.

The IP and Logistics Manager will work closely with regulatory affairs, manufacturing partners, clinical operations, and site teams to ensure operational excellence, quality assurance, and regulatory compliance throughout the clinical trial lifecycle.

Key Responsibilities: 

Investigational Product (IP) Management:  

Oversee the end-to-end management of investigational products, including planning, manufacturing coordination, labeling, packaging, and distribution to clinical trial sites. 

Ensure all IP processes adhere to Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and regulatory requirements across jurisdictions. 

Coordinate with manufacturers to ensure IP stability testing, shelf-life assessments, and compliance with protocol specifications. 

Manage labeling requirements, ensuring compliance with local and international standards for investigational product use. 

Monitor IP inventory, track expiration dates, and oversee proper disposal of unused products. 

Pharmacy Evaluation and Preparation: 

Conduct comprehensive assessments of site pharmacies to evaluate their readiness for clinical research, ensuring compliance with GCP standards. 

Design and implement site pharmacy improvement plans to address gaps in infrastructure, equipment, and staffing. 

Establish workflows and systems for IP storage, handling, and dispensing that meet study-specific requirements. 

Training and Capacity Building: 

Develop and deliver comprehensive training programs for site pharmacists, focusing on research pharmacy operations, IP accountability, and documentation best practices. 

Mentor pharmacists to become skilled research pharmacists capable of managing investigational products for clinical trials. 

Develop and implement site-specific standard operating procedures (SOPs) for pharmacy operations, aligned with regulatory and sponsor requirements. 

Regulatory Compliance and Coordination: 

Collaborate with the regulatory affairs team to ensure compliance with local and international regulatory requirements for IP management. 

Support the preparation and submission of regulatory documentation for IP manufacturing, import/export licenses, and stability testing. 

Maintain thorough documentation and records to facilitate regulatory audits and inspections. 

Supply Chain and Logistics Management: 

Coordinate the logistics of IP supply chains, ensuring timely and efficient delivery of investigational products to trial sites across multiple countries. 

Establish contingency plans to address potential supply chain disruptions, ensuring uninterrupted trial operations. 

Work closely with clinical operations to streamline logistics and address site-specific challenges. 

Quality Assurance: 

Conduct regular audits of IP management processes, site pharmacies, and logistics workflows to ensure compliance with protocols, SOPs, and regulatory guidelines. 

Implement quality assurance measures for IP storage, handling, and distribution, ensuring adherence to study requirements. 

Qualifications: 

Education: Bachelor’s degree in pharmacy, pharmaceutical sciences, supply chain management, or a related field required. Advanced degree (e.g., MSc, MPH, PharmD) in clinical pharmacy, regulatory science, or supply chain management preferred. 

Experience: 

5+ years of experience in investigational product management, pharmacy operations, clinical trial logistics, or a related field. 

Demonstrated experience with regulatory requirements for IP manufacturing, labeling, and stability testing. 

Strong track record of managing complex supply chains and logistics for clinical research in multi-country settings. 

Experience in training or capacity building for pharmacy staff is highly desirable. 

Skills and Competencies: 

Comprehensive knowledge of GCP, GMP, and regulatory standards for investigational product management. 

Strong project management skills, with the ability to manage multiple priorities across diverse locations. 

Proficiency in supply chain management systems and tools for inventory tracking and logistics coordination. 

Exceptional communication and leadership skills, with the ability to train and mentor teams effectively. 

Desired Attributes: 

Detail-oriented and highly organized, with a commitment to maintaining high-quality standards. 

Proactive problem-solver with the ability to address logistical and regulatory challenges in dynamic environments. 

Collaborative leader who thrives in cross-functional, multi-country teams. 

Work Environment: 

This position can be based in Harare, Zimbabwe, 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.