Clinical Operations Specialist

Position Title: Clinical Operations Specialist Location: South Africa Reports to: Associate Director, Clinical Operations Position Summary IAVI is seeking a highly motivated Clinical Operations Specialist (COS) who will be responsible for the day‑to‑day operational activities enabling the conduct of clinical trials according to ICH / GCP guidelines. Key Responsibilities Manage clinical vendors, including on‑site monitors and CROs, and oversee relevant sections of the Protocol Management Plan. Act as lead point of contact for clinical vendors, support vendor selection and contracting, train vendors, and monitor vendor performance against contractual and regulatory standards. Track vendor invoices for accuracy, send invoices for processing and payment. Provide initial and ongoing training to other departments and site staff to support conduct of clinical trial activities. Conduct risk planning and mitigation for vendors and clinical activities, working with CTM to mitigate risks and solve issues. Review, provide input, and draft assigned sections of key study documents; ensure approved monitoring plan is in place. Develop quality oversight plan for monitoring activities. Assist CTM in establishing study timelines and budgets for clinical aspects of trials and ensure clinical activities are conducted within timelines and budgets. Manage and oversee the completeness and accuracy of the Trial Master File (TMF) through appropriate reviews of all study related information, ensuring TMF is inspection ready. Work with CTM and other departments to oversee data quality through various means including data listings reviews. Prepare for and conduct site visits as needed, including site qualification, study initiation, interim monitoring, and close‑out visits. Provide study status updates to project team and management as needed. Act as clinical operational lead on observational studies as assigned and oversee studies IAVI monitors for other sponsors. Departmental and Knowledge Development Activities Participate in or initiate clinical development departmental activities as assigned (e.g., drafting/reviewing operational procedures, participating in departmental meetings). Provide support and back‑up to senior departmental personnel as needed, including attending meetings, assuming lead in study team meetings, generating and/or reviewing minutes, and following up on action items. Remain up to date on clinical trial methodology, ICH GCP, FDA regulations, EMA regulations, and other local/international regulatory and ethical guidelines and requirements. Remain abreast of scientific knowledge of targeted disease and population and investigational product(s). Participate in training activities for new staff, as needed. Education and Work Experience Undergraduate degree in a scientific or related field is required. Minimum 5 years of clinical trials experience is required, including clinical monitoring, preferably with clinical team lead experience. Qualifications and Skills Ability to conduct presentations of technical information concerning specific projects. Outstanding interpersonal skills and ability to work effectively in a cooperative and collaborative manner with all levels, and across functional teams both internally and externally. Ability to work on problems of moderate complexity and diverse scope using good judgment within defined procedures and policies to determine appropriate action. Excellent project planning and implementation skills in a cross‑disciplinary and multi‑cultural team. Excellent knowledge of ICH GCP and FDA CFR guidelines as well as the Declaration of Helsinki and relevant country‑specific regulations. Excellent oral and written communication skills. Proven ability to coordinate and lead multi‑disciplinary project teams. Professional demeanor, pleasant manner, and positive "can‑do" attitude. Flexibility to change priorities and be comfortable with changing deadlines to meet organizational needs. Excellent computer skills and proficiency in Microsoft Word and Excel. Ability to travel up to 50% of the time. High level of independence in performing responsibilities is highly desirable. Ability to mentor other staff including Clinical Trial Associates and Clinical Research Associates is highly desirable. Disclaimer Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of personnel so classified. This document does not create an employment contract, implied or otherwise, other than an "at‑will" relationship. EEO Statement IAVI is an equal opportunity employer and applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. IAVI is an equal opportunity employer actively committed to fostering a diverse and inclusive global organization. IAVI believes that diversity and inclusion among our teammates is critical, and we seek to recruit, develop and retain the most talented people from a representative candidate pool. IAVI upholds these principles through IAVI's Global Diversity and Inclusion Committee. IAVI has zero tolerance for discrimination or harassment on the basis of race, color, ethnicity, caste, national origin, home language, ancestry, religion, marital or civil partnership status, age, physical or mental disability, HIV status and any other medical condition, genetic information, pregnancy, sexual orientation, gender identity or expression, and veteran status, in addition to any other status protected under the law in any of our locations worldwide. #J-18808-Ljbffr