Principal Investigator (Clinical Research)

About the role

InnoHeza Ltd is seeking a qualified Principal Investigator to lead the clinical investigation of a postpartum hemorrhage medical device at the designated study site in Rwanda. The PI will provide clinical leadership throughout protocol development, regulatory submission, and study conduct, ensuring participant safety and data integrity.

Key responsibilities

• Provide clinical expertise during development, review and finalisation of the study protocol and related documents.
• Collaborate with sponsor, regulatory lead, biostatistician and clinical advisors on objectives, endpoints, eligibility criteria and safety monitoring plans.
• Ensure protocol compliance with ISO 14155, ICH‑GCP, Rwanda FDA and ethics requirements.
• Support site selection, feasibility assessment and regulatory/ethics submissions.
• Train investigators, nurses, midwives and study staff.
• Oversee participant screening, consent, device use, follow‑up and safety monitoring.
• Report adverse events, serious adverse events, device deficiencies and protocol deviations.
• Maintain complete source documentation, case report forms and essential study records.

Required profile

• Qualified medical professional with experience as a Principal Investigator in clinical trials.
• Demonstrated knowledge of postpartum hemorrhage care and medical device investigations.
• Familiarity with Rwanda’s regulatory environment and ethics committee processes.

Required skills

• ISO 14155 compliance
• ICH‑GCP standards
• Rwanda FDA regulatory requirements
• Clinical trial protocol development
• Adverse event reporting and safety monitoring