Marisa Russell
Cape Town
Summary
Accomplished leader in clinical operations with extensive experience managing the full lifecycle of clinical trials in CRO and non-profit sectors. Proven expertise in tuberculosis, HIV, and emerging infectious disease vaccines, particularly in resource-limited settings across Africa. Skilled in leading diverse global teams to navigate complex challenges and achieve significant outcomes. Proficient in vendor selection, grant writing, and budget management, with a strong focus on innovation and continuous improvement.
Overview
28
28
years of professional experience
Work History
Snr Director Global Clinical Operations & SA Lead
IAVI
Cape Town
12.2021 - Current
- Provide strategic oversight of the full clinical trial lifecycle for phase 1, 2 and 2b trials, proactively managing risks and ensuring compliance with regulatory requirements, budgets, and internal processes.
- Lead vendor selection, budget negotiations, and contracting, with executive oversight of vendor performance, compliance, and financial management.
- Manage departmental budgets for clinical trials in portfolio, ensuring alignment with strategic objectives and financial oversight.
- Drive departmental process improvements and implement effective systems to streamline clinical operations.
- Lead country office operations, ensuring regulatory compliance while recruiting and retaining high-performing talent across departments to enhance operational effectiveness.
- Contribute to grant development, manage multi-funder portfolio budgets, and support funder reporting requirements.
Associate Director / Director, Clinical Operations
IAVI
03.2020 - 11.2021
- As above excluding country office management responsibilities.
Senior Clinical Trial Manager - Consultant
IAVI (Previously AERAS)
06.2017 - 02.2020
- Led phase 2b TB vaccine trial, coordinated vendors, maintained quality, identified risks, managed budget, and organised daily operations.
Director / Senior Director, Clinical Operations
International Partnership for Microbicides
06.2014 - 01.2017
- Led multidisciplinary clinical operations teams, managing departmental budget and ensuring compliance with SOPs to enhance operational efficiency.
- Managed CROs, vendors, investigators and research centres, including selection, contracting and performance oversight.
- Directed delivery of Phase 1–3 trials, including pivotal phase 3 HIV prevention trial, ensuring adherence to timelines and regulatory standards.
- Led project management for Clinical Affairs activities supporting regulatory submissions and eCTD preparation.
- Collaborated with partner organisations on trials involving IPM products, ensuring compliance with regulatory filing requirements and maintaining trial quality standards.
- Contributed to protocols, clinical development plans, clinical study reports and social-behavioural studies.
- Managed CROs, vendors, investigators and research centres, including selection, contracting and performance oversight.
Clinical Development Consultant
International Partnership for Microbicides
06.2013 - 05.2014
- Project management of a phase 1 HIV prevention product including vendor oversight, quality management, risk identification, budget management and day-to-day operational management.
Director Clinical Operations
Quintiles (presently IQVIA)
05.2008 - 05.2013
- Led Cape Town office and South African clinical operations teams, including quality management.
- Established clinical quality plan for Africa to monitor issues, trends and training needs.
- Set up site start-up unit for Africa.
- Supported business development activities for Africa region, including proposal and budget development and bid defense meetings.
- Allocated project resources to maximise staff utilisation across programmes.
- Acted as customer relationship manager for key local affiliate clients.
- Represented Africa region on global process improvement working initiatives.
Clinical Trial Manager
Quintiles (presently IQVIA)
08.2001 - 04.2007
- Line management of CRAs and CTAs.
- Local project management.
Clinical Research Associate
IQVIA
Cape Town
12.1998 - 09.2001
- Monitored clinical trials for compliance with protocols and regulations, safeguarding participant safety and data integrity.
Education
B.Sc. - Human Physiology, Zoology
University of Stellenbosch
South Africa01-1998
B.Sc. Honors - Human Physiology
University of Stellenbosch
South Africa01-1999
Skills
- Clinical Trial Operations
- Vendor Management
- Trial Budgeting
- Quality Management
- Risk Management
- Process Improvement
- Country Leadership
- Cross-Functional Collaboration
- Team Leadership
- Problem Solving
- Business Development
Publications
- Live-attenuated Mycobacterium tuberculosis vaccine, MTBVAC, in adults with or without M tuberculosis sensitisation: a single-centre, phase 1b-2a, double-blind, dose-escalation, randomised controlled trial., Lancet Glob Health, 2025-06-01, 13, 6, e1030-e1042, 10.1016/S2214-109X(25)00046-4, 40250461
- Immunogenicity, safety, and efficacy of the vaccine H56:IC31 in reducing the rate of tuberculosis disease recurrence in HIV-negative adults successfully treated for drug-susceptible pulmonary tuberculosis: a double-blind, randomised, placebo-controlled, phase 2b trial., Lancet Infect Dis, 2025-07-01, 25, 7, 751-763, 10.1016/S1473-3099(24)00814-4, 40056922
- Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women., N Engl J Med, 2016-12-01, 375, 22, 2133-2143, 10.1056/NEJMoa1602046, 27959766
- Drug-drug Interactions between the Dapivirine Vaginal Ring (Ring-004) and Miconazole Nitrate Vaginal Capsule (GynoDaktarin)., AIDS Research and Human Retroviruses, 2014-01-01, 30, S1, A144-A144
Timeline
Snr Director Global Clinical Operations & SA Lead
IAVI
12.2021 - Current
Associate Director / Director, Clinical Operations
IAVI
03.2020 - 11.2021
Senior Clinical Trial Manager - Consultant
IAVI (Previously AERAS)
06.2017 - 02.2020
Director / Senior Director, Clinical Operations
International Partnership for Microbicides
06.2014 - 01.2017
Clinical Development Consultant
International Partnership for Microbicides
06.2013 - 05.2014
Director Clinical Operations
Quintiles (presently IQVIA)
05.2008 - 05.2013
Clinical Trial Manager
Quintiles (presently IQVIA)
08.2001 - 04.2007
Clinical Research Associate
IQVIA
12.1998 - 09.2001
B.Sc. - Human Physiology, Zoology
University of Stellenbosch
B.Sc. Honors - Human Physiology
University of Stellenbosch