Job Title: Associate Director, Clinical Research Management Africa
Reports to: Senior Director, Global Clinical Operations
The position has the following key responsibilities:
- Supervise team of CPMs and CRAs based in Africa
- Together with Senior Director, Global Clinical Operations, oversee and manage Africa-based CPMs’ and CRAs’ study assignments and workloads
- Provide oversight and support to CPMs and/or CRAs in planning to develop, set-up, train, evaluate, and monitor sites participating in observational epidemiology studies and clinical trials of AIDS vaccines
- Work closely with the CPMs and/or CRAs to ensure protocols and study related activities are conducted according to program priorities, timelines and in compliance with protocol and ICH GCP guidelines
- Liaise with CPMs, CRAs and data management to resolve data management problems
- Act as back up when a CPM or CRA is temporarily unable to fulfill role (e.g leave, illness, pregnancy)
- As needed, coordinate Site Initiation Visits prior to study start as well, clinical trainings, and develop written materials need for clinical trial conduct
- Contribute to development of annual Statements of Work and associated CRC budgets by providing programmatic input
- Responsible for GCP trainings and tracking trainings within Africa program
- Conduct special assessments of clinical operations (e.g. data security assessment)
- Support QA/QC initiatives undertaken internally and with external partners conducting IAVI sponsored trials
- Ensure ethics and regulatory submissions occur in a proper and timely fashion
- Review regularly updated reports from CPMs, CRAs, sites, and/or CROs regarding study progress including recruitment, trial conduct. Work with CPMs and/or CRAs to identify site-related problems and propose resolutions as needed.
- Other relevant duties as assigned.
Experience and Skills:
- Requires master’s degree in scientific field, life science or public health. RN or Clinical Officer is highly desirable. Minimum of 10 years of clinical research experience with a proven and successful track record in monitoring and management of investigational sites in large multi-center clinical trials preferred.
- Strong supervisory and management experience of monitors and trial staff required
- Strong clinical project management skills
- Experience working with Contract Research Organizations (CROs) and/or contract CRAs providing monitoring services.
- Experience with HIV and/or vaccine clinical research trials, HIV related laboratory procedures and/or clinical safety laboratory testing is required
- Strong proficiency in Good Clinical Practices (GCP), ICH guidelines and regulatory procedures with the ability to train site personnel as needed. Proven track record of meeting clinical trials milestones, timelines and working closely with clinical trial sites to ensure objectives are met.
- Able to adapt to diverse educational and cultural backgrounds and maintain a high standard of professional conduct as a representative of IAVI
- Able to take responsibility for completion of tasks with high quality according to established program timelines, identify problems and possible solutions and assess the impact on timelines
- Must be team player and able to effectively work across multiple cross-functional areas within an organization
- Strong communication skills and proven ability for effective communication verbally, in writing, and through email
- Flexibility and willingness to travel to research centers as needed
IAVI operates as an intense mission-driven organization trying to solve one of the most difficult and important scientific challenges of our time, so we seek someone who feels passion for IAVI’s goal of ending AIDS.
About the Organization
The International AIDS Vaccine Initiative (IAVI) is a nonprofit scientific organization founded in 1996 whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. IAVI believes that our capabilities, partnerships and commitment position us to make meaningful impact in the field. IAVI continues to focus on AIDS vaccine development as the most effective long-term approach to ending the HIV epidemic. Ending the epidemic will also require innovation and an integrated approach across prevention and treatment efforts in line with the shifting epidemic. IAVI will contribute to the field by:
IAVI’s Strategic Initiatives
- Establishing an integrated approach to HIV vaccine and prevention research and development, linking an understanding of at risk communities with the most potentially relevant interventions.
- Bringing new capabilities and innovation to the field through novel collaborations to accelerate product development.
- Prioritizing approaches that have the greatest potential impact on HIV vaccine and prevention efforts towards diminishing and ultimately ending the epidemic
IAVI's strategic focus revolves around the following four pillars:
Financial and Operational highlights
- Engage locally: Engaging the communities most at-risk of HIV infection;
- Accelerate Translation: Providing an integrated product development platform to accelerate the translation of promising concepts into HIV vaccine candidates for the field;
- Catalyze Innovative Science: Investing in high potential discovery programs that could transform HIV vaccine development and beyond;
- Secure Sustained Support and Action: Generating supportive data and messages to drive policies and investments that will end the epidemic.
- Approximately 180 employees (80 located at Headquarters in New York)
- Offices in Amsterdam, New York, Johannesburg, Delhi, and Nairobi along with laboratories in La Jolla, London, Delhi, and Brooklyn.
- Total revenue of $100 million