Key Responsibilities:

• Support Project Teams with the development of quality management plans relevant to the specific project(s);
• Support and prepare Project Teams for regulatory inspections and external Sponsor audits;
• Serves as the GCP point person for the IAVI electronic QMS, and Clinical Trial Systems, development and implementation;
• Develop and implement QMS compliance assessments for the GCP component of the QMS;
• Develop and implement an eTMF inspection readiness assessment plan for all IND studies;
• Participate in executing the audit plan as delegated;
• Provide training to GCP Operations on best practices and trends as indicated;
• Oversees implementation of GCP CAPAs and conduct the required effectiveness checks;
• Perform other tasks as assigned by the manager.

Education and Work Experience:

• Masters Degree or equivalent in Clinical Research and/or Public Health or related field is required.
• Minimum 10 years of experience in clinical research is required of which at least 3 in Quality Assurance is required.
• Certification as GCP Auditor and/or Post Graduate Qualification in Quality Management is highly preferred.

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Key Responsibilities:

Clinical Trials and Observational Studies

• Ensure all clinical activities conducted are aligned with the overall program insofar the preparation and execution of assigned clinical research studies.
• Develop strategic and detailed implementation plans and procedures for assigned clinical research studies/trials.
• Provide oversight of clinical protocols, consent forms, data collection instruments, and preparation of suitable educational materials and regulatory documents for clinical research studies/trials.
• Provide advice on clinical trials and epidemiological studies, particularly to the preclinical groups on the design of studies and their relationship to the overall clinical development plan, as appropriate.
• Yield data required for design of efficacy trials appropriate to the populations for which vaccine candidates are designed, and/or which yields specimens for research that may elucidate the natural history, pathogenesis, and immune control of infection relevant for vaccine design. 
• Lead Protocol Teams for assigned clinical studies.
• Lead communication with the Principal Investigators and select external stakeholders, as deemed appropriate for assigned projects.
• Design analysis plans with attention to endpoint selection and measurements, adverse event management, and data collection, and conduct of the interim and final analysis meetings.
• Chair and manage the Protocol Safety Review Team (PSRT), prepare the PSRT Charter and participate in the review of blinded safety data for assigned projects.
• Coordinate the selection of Independent Data Monitoring Committee (IDMC) Members, and preparation of the IDMC Charter in partnership with and under leadership of Head of Clinical Development or delegate.
• Act as IDMC liaison, as directed by Head of Clinical Development or delegate.
• Act as medical monitor for the conduct of clinical trials with a focus on safety data monitoring, as will be instructed by Head of Clinical Development or delegate.
• Provide oversight of CRO partner medical monitoring for studies where medical monitoring is outsourced.
• Prepare interim and final reports in collaboration with the site investigators and other members of IAVI Clinical Development for clinical research studies/trials involved in.
• Collaborate with site investigators to collect, analyze, and report the data from studies in scientific meetings and publications as directed by Head of Clinical Development or delegate.
• Support activities and contribute to design Clinical Development Plans, in collaboration with other members of Clinical Development and clinical investigators, including late phase clinical trials, if candidates are successful.
• Participate in the development and implementation of training activities relevant to projects involved in.

Other duties 

• Maintain in-depth medical/scientific knowledge about the assigned therapeutic area or product/ project involved in, including any unique properties involving both disease and products for which the incumbent is responsible.
• Perform other duties as assigned by the VP, Head of Clinical Development.

Education and Work Experience:

• A Medical degree is required.
• Minimum 6 years of experience in clinical research is required.
• Board certification or equivalent in Medicine, Pediatrics, Infectious Diseases, or pharmaceutical medicine is highly desired.