Job Title: Clinical Trial Manager / Senior Clinical Trial Manager
Location: Cape Town, South Africa; Remote - South Africa; OR Nairobi, Kenya
Reports to: Director, Clinical Operations
Help IAVI translate science into global health impact as a Clinical Trial Manager!
IAVI is seeking a highly motivated Clinical Trial Manager(CTM) /Senior Clinical Trial Manager who manages, oversees and executes day-to-day operational activities for the conduct of clinical trials according to ICH/GCP guidelines and relevant regulatory guidelines. The (Sr.) CTM will lead clinical operations of early and late phase and/or highly complex clinical trials, mentor other clinical operations staff, and lead process improvement.
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 Associate Director and/or 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 Associate Director, and/or 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 assist in developing 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.
- 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 of 5 years experience in Trial operations and two years of trial management experience for CTM; Minimum of 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 for Sr. CTM level.
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.
- Experience in project management, including skills and the ability to deliver on assigned tasks within deadlines is required.
- Experience leading multi-disciplinary clinical trial teams, effectively to deliver clinical trials at high quality, on time and within budget is required.
- Strong interpersonal skills and ability to work effectively with outside vendors, collaborators, subordinates and functional peer groups at various management levels.
- Ability to work on problems of high complexity and diverse scope using good judgment within defined procedures and policies to determine appropriate action is highly desirable.
- 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 highly desirable.
- 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.
- Experience working collaboratively with people of diverse educational and cultural backgrounds and maintain a high standard of professional conduct as a representative of IAVI is required.
- Experience 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 and managing vaccine trials in Sub-Saharan Africa 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:
- Commitment: We deliver on our mission, proactively transforming promises into tangible results
- Stewardship: We steward IAVI's resources responsibly to ensure IAVI's long-term success and global health impact
- Integrity: We uphold strong moral principles to maintain our credibility as a nonprofit scientific research organization
- Collaboration: We work as one IAVI team and partner with others to deliver globally accessible, urgently needed, public health solutions
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. 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.
Compensation And Benefits Information:
Salary is paid in local currency, and is commensurate and competitive with the local labor market. Please note, there may be some variation based on experience level. In addition, this position offers competitive benefits including: generous retirement savings plan employer contributions; competitive health, dental and vision insurance plans; competitive paid time off policy; potential for annual bonuses based on performance; and other benefits. More information can be found on IAVI's career page.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
