In this position, you will own the operational execution of clinical validation studies at all assigned international sites. Reporting to the Evidence & Access Lead, where s/he sets strategy and owns external relationships, your role as the Validations Manager will be to design, supervise and manage analytical studies, feasibility studies, clinical trials and implementation studies from conception to finalization. Core requirements are to ensure protocols are followed, data are clean and audit-ready, blinding is enforced, reagents and samples are tracked, and every step from site initiation visit (SIV) to database lock is documented to a standard that will withstand WHO PQ and CE-IVDR regulatory scrutiny. The successful candidate will co-supervise a clinical research associate, responsible for quality clinical outcomes and site electronic Trial Master File (eTMF) support.
- Managing multi-centre diagnostic trials and studies, with the primary focus on feasibility, evaluation and demonstration studies that enable WHO review and regulatory approval
- Primary site contact for all protocol questions, reagent issues, logistics coordination, and reporting
- With partner sites, coordinate study ethics and regulatory submissions
- Lead site feasibility assessments, prepare SIV and training packages, work closely with collaborators and study sponsors, conduct monitoring visits, monitor enrolment against targets
- Coordinate preparation and characterisation of evaluation sample panels: reference strain sourcing, aliquot storage, periodic quality checks
- Building capacity at investigational sites, providing ongoing training and monitoring (including travel to sites) to review study progress, ensure protocol compliance and data integrity
- Setting up and maintaining TMF for clinical trials as well as helping sites establish Investigational Site Files – ethics approvals, site agreements, SIV records, training logs, monitoring reports, protocol amendments, correspondence
- Writing of reports, publications and scientific presentations (incl. travel for presentations)
- Ensure site activities comply with ICH-GCP E6 (R3) and applicable local requirements; ISO 20916:2019 and ICMR-CDSCO protocols impose equivalent quality obligations
- 3–6 years in IVD or clinical diagnostics research with hands-on site-level study conduct responsibility
- BSc/MSc in biomedical sciences, clinical microbiology, medical laboratory science, or tropical medicine. Advanced degree preferable.
- Practical understanding of diagnostic accuracy study design: sensitivity/specificity, reference standard limitations, blinding requirements
- Scientific and/or technical understanding of the design and development of diagnostics
- Experience and track record of planning and conducting clinical studies
- Relevant experience working in low and middle-income countries
- Ability to multitask and work in a rapidly changing environment, across different time zones
- Ability to work collaboratively in teams of multi-cultural backgrounds; effective communication
- GCP certification current or obtainable within 3 months of hire; TMF documentation experience
- ISO 20916:2019 or WHO PQ/CE-IVDR submission-quality study experience; prior CRA or clinical monitor experience at a CRO or academic research organisation
- Strong written English
Prior work in sub-Saharan Africa or Middle East health system; knowledge of
- 1 African regulatory authority ethics and device evaluation requirements
- Strong technical knowledge of TB, HIV, STIs and hepatitis diagnostics and laboratory standards
- Portuguese and/or Spanish professional proficiency
- Direct experience coordinating studies in LATAM: CONEP/CEP ethics, ANVISA import processes, or REBEC registry
- Familiarity with arboviral, tropical disease diagnostics (Dengue, Chikungunya, Malaria and emerging pandemic threats) and laboratory standards
