Principal Investigator

Company Description InnoHeza Ltd is a Rwanda-based medical technology company dedicated to developing innovative, evidence-based solutions that address critical unmet healthcare needs. The company focuses on identifying real-world clinical challenges and translating them into practical, safe, and accessible medical technologies through research, product development, testing, clinical evaluation, and regulatory pathways. InnoHeza works collaboratively with healthcare professionals, academic institutions, regulatory authorities, technical experts, and other public and private partners to ensure its solutions are responsive to local healthcare environments while meeting recognized quality and ethical standards. Through responsible innovation and continuous improvement, InnoHeza aims to improve patient outcomes and expand access to effective healthcare technologies in Rwanda, across Africa, and beyond.

Role Description We are seeking a qualified Principal Investigator (PI) to provide clinical leadership during protocol development and to lead the conduct of the clinical investigation at the assigned

study site. The PI will collaborate with the Sponsor, Clinical Trial Design & Regulatory Lead,

Biostatistician, and Clinical Advisors to ensure the protocol is clinically appropriate, ethically

acceptable, operationally feasible, and suitable for Ethics Committee and Rwanda FDA

submission. The PI is responsible for participant safety, protocol compliance, clinical

oversight, and data integrity throughout the study.

Key Responsibilities

• Provide clinical leadership and expert clinical input during development, review, and finalization of the clinical protocol.
• Collaborate with the Sponsor, Clinical Trial Design Consultant, Regulatory Lead, Biostatistician, and Clinical Advisors on study objectives, endpoints, eligibility criteria, safety monitoring, participant flow, follow-up schedule, and clinical workflow.
• Ensure the protocol aligns with ISO 14155, ICH-GCP, Rwanda FDA requirements, ethics requirements, and routine postpartum hemorrhage care.
• Review and clinically approve protocol, informed consent forms, CRFs, source documents, device-use procedures, and other investigator-facing documents.
• Support clinical site selection and assess site feasibility and readiness.
• Support regulatory and ethics submissions by providing clinical justification and responding to clinical questions.
• Lead or support training of investigators, nurses, midwives, coordinators, and delegated staff.
• Provide overall clinical oversight of study conduct at the assigned site.
• Supervise participant screening, eligibility assessment, informed consent, investigational device use, follow-up, and safety monitoring.
• Ensure investigational device use never delays standard emergency postpartum hemorrhage management.
• Identify, assess, document, and report adverse events, SAEs, device deficiencies, and protocol deviations.
• Maintain complete source documentation, CRFs, essential documents, and site records.
• Participate in monitoring visits, audits, inspections, safety reviews, and protocol amendment discussions.
• Contribute to interpretation of study results and preparation of clinical study reports and regulatory evidence.
• Protect participant rights, safety, confidentiality, and data integrity.

Selection Criteria

MUST HAVE CRITERIA

• Licensed Medical Doctor (MD, MBBS, or equivalent) with valid registration with the Rwanda Medical and Dental Council.
• Current appointment or affiliation with a hospital providing emergency obstetric services.
• Availability for the full study duration and ability to provide ongoing PI oversight.
• Experience or capability to serve as Principal Investigator with appropriate GCP training.
• Ability to supervise delegated staff and ensure participant safety, protocol compliance, and accurate documentation.
• Willingness to comply with ISO 14155, ICH-GCP, Rwanda FDA, ethics requirements, and sponsor procedures.
• Specialist in Obstetrics and Gynecology, or senior clinician with substantial emergency obstetric experience.

STRONG PREFERENCE FOR

• Previous PI or Sub-Investigator experience in interventional clinical research.
• Hands-on experience managing postpartum hemorrhage.
• Familiarity with ISO 14155 and medical device clinical investigations.
• Leadership experience in maternal health or hospital quality improvement.
• Familiarity with medical device clinical investigation requirements and participant safety
• oversight.
• Ability to work collaboratively with midwives, anesthetists, theatre teams, blood bank/laboratory staff, study coordinators, and sponsor teams.

NICE TO HAVE

• Experience contributing to protocol development as a clinical expert.
• Completed GCP training within the last two years.
• Experience with device usability or human factors studies.
• Experience supporting ethics or regulatory submissions.
• Experience contributing to clinical study reports or scientific publications.
• Fluency in English and Kinyarwanda for local clinical communication, sponsor communication, and participant-facing activities.
• Experience working with ethics committees, regulatory authorities, sponsor monitors, DSMBs, or independent safety reviewers.

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