Clinical Operations Manager (Clinical Operations Development)

About the role

The International Vaccine Institute is looking for a Clinical Operations Manager to lead multi‑regional clinical trials of moderate complexity. This is a 2‑year renewable position based in Africa, reporting to the Head of Clinical Operations and collaborating with CROs, investigators, and project teams.

Key responsibilities

• Support study design, protocol development, and preparation of study documents (ICF, IAF, DCs, SOPs, GXP procedures).
• Coordinate on‑site CRO visits, monitor CRO performance, and ensure compliance with local regulations, ICH‑GCP, and study protocols.
• Prepare and submit regulatory documents, oversee IRB submissions, and manage trial master file (TMF) quality control.
• Manage clinical trial supplies, IP shipment, and handling in collaboration with manufacturers.
• Lead development of SOPs/MOPs, facilitate project meetings, and track action items.
• Coordinate CAPA responses, coach new team members, and develop monitoring tools.

Required profile

• Bachelor’s, Master’s or PhD degree in a relevant scientific field or equivalent experience.
• Proven experience in clinical trial management, preferably with CRO oversight.
• Strong knowledge of ICH‑GCP, local regulatory requirements, and IRB processes.

Required skills

• Clinical trial protocol development
• CRO monitoring and management
• Regulatory submission preparation
• Trial Master File (TMF) maintenance
• Investigational product (IP) logistics and handling
• CAPA coordination
• Development of SOPs/MOPs

What we offer

• Opportunity to work on impactful vaccine research projects.
• Collaborative international environment.
• Professional development and training opportunities.