Serve as primary TMF contact for assigned studies, ensuring files are complete and inspection-ready throughout the study lifecycle.
Develop and maintain study-specific TMF documents and provide training to internal and external stakeholders.
Perform periodic file inventories and reconcile expected document lists based on study milestones.
Alimentiv is a clinical services company specializing in Trial Master File (TMF) operations for clinical studies. They are a global organization with teams in multiple countries, fostering a collaborative and professional culture focused on quality and compliance.
Perform on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visits to ensure sites are adequate for study conduct.
Verify investigator qualifications, resources, facilities, equipment, and staff for clinical study conduct.
Train site staff, support regulatory/EC submissions, and mentor junior staff during co-monitoring visits.
Ergomed Group is a global clinical research organization helping biopharmaceutical companies develop and deliver therapies in oncology, rare disease and other complex areas. Its diverse teams across countries and time zones collaborate with kindness, curiosity and a shared sense of purpose.
Prepare, conduct, and report on all types of monitoring visits.
Ensure compliance with study protocols, ICH-GCP guidelines, and regulatory requirements.
Perform source data verification and manage site-level risks.
PSI is a leading Contract Research Organization with 30 years in the industry, offering a perfect balance of stability and innovation to clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Conduct and report all types of onsite monitoring visits and be involved in study startup.
Perform CRF review, source document verification, and query resolution while managing site communication.
Support regulatory team in preparing documents and participate in feasibility research.
PSI is a leading Contract Research Organization with 30 years in the industry, offering a balance between stability and innovation to clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.