Back to jobsProviding operational and administrative support across all phases of clinical trials, ensuring smooth execution from start-up through close-out
Setting up and maintaining electronic Trial Master Files (eTMF) and Investigator Site Files (ISF), ensuring timely document approval, filing, and archiving
Supporting document collection, preparation, and submission to Regulatory Authorities and Ethics Committees
Coordinating clinical supply and equipment activities including ordering, import processes, and inventory tracking in collaboration with CRAs and Project Managers
Ensuring cross-functional collaboration with internal teams and external stakeholders including sites, health authorities, and ethics committees
Supporting inspection readiness, audit activities, and continuous quality oversight to maintain compliance with ICH-GCP and regulatory requirements
Co-monitoring visits with CRAs to support sites with documentation backlogs and quality maintenance
