Clinical Operations Specialist or Senior Clinical Operational Specialist

The International AIDS Vaccine Initiative (IAVI) is a global not-for-profit, public-private partnership working to accelerate the development of vaccines to prevent HIV infection and AIDS. IAVI is seeking a Clinical Operations Specialist (COS) or Senior Clinical Operational Specialist to manage clinical vendors and oversee clinical trial activities.

Role Overview

The role involves managing clinical vendors (including on-site monitors and CROs) and overseeing relevant sections of the Protocol Management Plan. The Specialist will ensure clinical activities are conducted within timelines and budget while maintaining the highest quality standards and regulatory compliance.

Key Responsibilities

Clinical Operations

• Vendor Management: Serve as the lead point of contact for clinical vendors; support selection, contracting, and training. Monitor performance against contracts, ICH GCP, SOPs, and local regulatory/ethical standards.
• Quality Oversight: Review site visit reports and conduct quality oversight visits. Track vendor invoices for accuracy and process payments.
• Training: Provide initial and ongoing training to site staff and other departments to support clinical trial conduct.
• Risk Management: Conduct risk planning and mitigation for vendors and clinical activities in collaboration with Clinical Trial Managers (CTMs).
• Documentation: Review and draft sections of key study documents. Ensure an approved monitoring plan and quality oversight plan are in place.
• Trial Master File (TMF): Oversee the completeness and accuracy of the TMF to ensure it is inspection-ready.
• Site Visits: Prepare for and conduct site qualification, study initiation, and quality oversight visits.
• Study Leadership: Act as clinical operational lead on observational studies and oversee studies IAVI monitors for other sponsors.

Departmental and Knowledge Development

• Participate in drafting or reviewing operational procedures and departmental meetings.
• Support senior personnel by assuming lead roles in study teams or ad-hoc meetings when necessary.
• Maintain up-to-date knowledge of clinical trial methodology, ICH GCP, and international/local regulatory guidelines.
• Stay abreast of scientific knowledge regarding targeted diseases and investigational products.

Requirements and Qualifications

• Education: Bachelor’s degree in a scientific or related field is required.
• Experience (Specialist): Minimum 4 years of clinical trials experience, including clinical monitoring. Clinical team lead experience preferred.
• Experience (Senior Specialist): Minimum 6 years of clinical trial experience. Clinical Team Lead experience is required.
• Regulatory Knowledge: Deep understanding of ICH GCP, FDA CFR guidelines, the Declaration of Helsinki, and relevant country-specific regulations.
• Travel: Ability to travel up to a maximum of 50% of the time as needed.

Required Skills

• Excellent oral and written communication skills.
• Strong project planning and implementation skills in multi-cultural environments.
• Ability to solve complex problems and work independently.
• Proficiency in Microsoft Word and Excel.
• Familiarity with emerging infectious diseases and managing trials in West Africa is highly desirable.

How to Apply

Interested and qualified candidates should apply through the official recruiting portal: IAVI Careers.