Requirements: English
Company: Philogen S.p.A.
Region: Treviso , Veneto
Philogen S.p.A. is a biotechnology company dedicated to developing biologic products for imaging and therapy of life-threatening diseases, with a focus on cancer and rheumatologic disorders.We are currently seeking a highly organized, detail-oriented Clinical Trial Assistant to join our dynamic team.This individual will play a crucial role in supporting our clinical trial operations, overseeing both the paper trial master file (pTMF) and the electronic trial master file (eTMF) systems. The position is reserved for candidates belonging to protected categories according to Law 68/99.Responsibilities:Assist in preparing, assembling, and distributing clinical trial documentation and reports.Manage and maintain the pTMF and eTMF systems, ensuring timely submission, archival of documents, completeness, and accuracy. Conduct regular quality checks on the TMF system.Organize Compassionate Use documentation and pre-clinical study reports library.Support the clinical trial team in organizing, planning, and executing clinical trials in compliance with SOPs, GCP, and regulatory requirements.Coordinate with project managers, clinical operations, quality staff, and other teams for document collection and retention.Review study-related documents for completeness and compliance.Train personnel on standards and TMF-related activities.Assist in resolving issues during clinical trials.Participate in regulatory and internal audits, supporting preparation and follow-up activities.Required Skills and Qualifications:Bachelor''s degree in life sciences, healthcare, or related field.Experience in a similar role within pharma or biotech is preferred but not mandatory.Knowledge of clinical research processes, GCP, and regulatory requirements.Familiarity with eTMF and clinical trial management systems is desirable.Excellent organizational and attention-to-detail skills.Strong communication skills, both written and verbal.Ability to work efficiently in a fast-paced environment managing multiple priorities.Proficiency in MS Office (Word, Excel, PowerPoint).Job Location: Siena, Italy#J-18808-Ljbffr