Senior Clinical Trial Manager - International AIDS Vaccine Initiative - Table View

Position Description Job Title: Senior Clinical Trial Manager Location: South Africa Reports to: Associate Director, Clinical Operations Position Summary: IAVI is seeking a highly motivated Senior Clinical Trial Manager (CTM) who will be responsible for the management, oversight, and execution of day-to-day operational activities for the conduct of clinical trials according to ICH/GCP guidelines and relevant regulatory guidelines. The successful candidate will be able to lead clinical operations of late phase and/or highly complex clinical trials, mentor other clinical operations staff, and lead process improvement efforts. Key Responsibilities: Develop the Protocol Management Plan (PMP) and coordinate the development of operations plans for all applicable functions for inclusion in the PMP. Develop study timelines and ensure adherence; Escalates concerns/issues related to timelines to senior management appropriately. Lead clinical trial team meetings and contribute clinical updates to cross-functional project team meetings. Oversee the evaluation, development, set-up, training, and monitoring of investigational sites participating in epidemiology studies and clinical trials. With oversight from the Director, Clinical Operations, develop and control study budgets, working with other departments as appropriate, to ensure execution of studies within budget; escalate concern /issues related to budget management to senior management appropriately. Assist the Director, Clinical Operations in determining which services will be conducted by IAVI and which will be outsourced to other vendors, and assists in the identification, evaluation and selection of CROs and other vendors. Proactively anticipate risks, and plan for and implement risk mitigation strategies throughout the trial conduct, keeping senior management informed appropriately. Actively manage issues that could impact study progress, and take actions or make recommendations to solve issues to support compliance Coordinate and develop study protocols. Develop Informed Consent Documents, Study Operations Manual, monitoring plan, tracking forms, and other study related documents as required. Lead implementation of risk-based monitoring for assigned studies. Review and approve monitoring visit reports submitted by CRAs for assigned studies. Complete monitoring oversight visits as needed to review clinical data for accuracy and completeness and resolve discrepancies in accordance with the study monitoring plan. Ensure all aspects of clinical trial conduct for assigned trials are appropriately conducted/delegated to relevant departments, clinical staff or vendors as needed, and ensure appropriate documentation, training, oversight and management of these tasks throughout the trial conduct in accordance with applicable SOPs, regulatory and ethical guidelines. Maintain good relations with IAVI collaborators and trial sites to facilitate site development and execution of clinical trials. Mentor and train CRAs and Clinical Trial Associates, Clinical Operations Specialists and Clinical Trial Managers as needed. When assigned a trial with a Clinical Operations Specialist (COS), delegate clearly defined clinical trial management activities to the COS and ensure deliverables are met with appropriate timeliness and quality; mentor and provide training to the COS as needed. Contribute to the Clinical Development (CD) departmental Standard Operating Procedures for conduct of clinical trials based on IAVI templates as well as ensure adherence to regulations/guidelines for GCP. Perform other duties as assigned by the manager. Education and Work Experience: Bachelor's degree in a scientific or related field is required; an advanced degree is highly preferred. Minimum 7 years relevant experience in clinical trial operations, including 4 years in clinical trial management or equivalent experience at study sponsor or CRO is required. Qualifications and Skills: Expert knowledge of clinical research operations, Good Documentation Practices, ICH GCP, FDA CFR and other relevant regulations as well as Declaration of Helsinki and relevant country-specific regulations is required. Strong project management skills and the ability to deliver on assigned tasks within deadlines is required. Proven ability to lead multi-disciplinary clinical trial teams effectively to deliver clinical trials at high quality, on time and within budget is required. High level of interpersonal skills and ability to work effectively with outside vendors, collaborators, subordinates and functional peer groups at various management levels is required. Ability to work on problems of high complexity and diverse scope using good judgment within defined procedures and policies to determine appropriate action is required. Flexibility to change priorities and be comfortable with changing deadlines to meet organizational needs is required. Being detail-orientated, with the ability to work independently on multiple projects/tasks with overlapping schedules and priorities is required. Following all company safety practices, Standard Operating Procedures (SOP's) and policies is required. Excellent oral and written communication skills are required. This includes ability to conduct presentations of technical information concerning specific projects and to be an effective trainer. Ability to mentor other clinical operations staff is required. Ability to work collaboratively with people of diverse educational and cultural backgrounds and maintain a high standard of professional conduct as a representative of IAVI is required. Familiarity with electronic document management systems such as Veeva as well as electronic data capture systems is required. Excellent computer skills with software tools needed to fulfill the responsibilities of position is required. Familiarity with HIV, TB, emerging infectious diseases and/or global health is highly desirable. Organizational Overview: IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Through scientific and clinical research in Africa, India, Europe, and the U.S., IAVI is pioneering the development of biomedical innovations designed for broad global access. We develop vaccines and antibodies in and for the developing world and seek to accelerate their introduction in low-income countries. IAVI programs and partnerships are grounded in the regions of the world where the disease burden is the greatest, and our approach emphasizes sustainability. Our network of clinical research center partners in Africa and India helps strengthen in-country research capacity and supports the training and education of the next generation of scientists. The global impact of our science includes fundamental contributions to understanding the biology of HIV infection, which IAVI and others are applying toward advancing vaccine science and immunology. IAVI accelerates scientific discovery and development by fostering unique collaborations among academia, industry, local communities, governments, and funders to explore new and better ways to address public health threats that disproportionately affect people living in poverty. Our global reach, including a clinical research network in five countries in sub-Saharan Africa and in India, has allowed us to make fundamental contributions to understanding the epidemiology, transmission, virology, and immunology of HIV. This work played a key role in facilitating the design of promising HIV vaccine candidates, as well as the discovery of broadly neutralizing antibodies that are now being advanced as promising approaches for HIV prevention. Our integrated capabilities in vaccine and antibody discovery, development, and clinical research take advantage of bio-pharmaceutical industry expertise to accelerate the development and testing of prevention methods for HIV and other diseases. Through the Product Development Center, we support external researchers with technical and scientific expertise to accelerate the development of their own products. IAVI CORE VALUES: Dedication to the Mission: We are committed to the translation of scientific discoveries into affordable, globally accessible public health solutions. Innovative Evolution: We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up Integrity: We are committed to meeting the highest ethical and professional standards in everything we do and to taking responsibility for our actions to earn respect Collaboration: We are committed to embracing diversity, the power of global teamwork and the belief that by working as one we can make a difference Disclaimer: Nothing in this 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. 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. At IAVI, we celebrate the spectrum of colleagues' experiences and believe that dedication to our mission above all is essential to our success as a scientific global non-profit. 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. Apply Now

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Senior Clinical Trial Manager - Table View

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