Requirements: English
Company: Philogen S.p.A.
Region: Siena , Tuscany
Philogen S.p.A. is a biotechnology company whosemission is the development of biologic products for the imaging andtherapy of life-threatening diseases, with a strategic focus oncancer diseases and rheumathologic disorders. We are currentlyseeking a highly organized, detail-oriented Clinical TrialAssistant to join our dynamic team. This individual will play anessential role in supporting our clinical trial operations andoverseeing both the paper trial master file (pTMF) and theelectronic trial master file (eTMF) system. The position isreserved for candidates belonging to protected categories accordingto Law 68/99. Responsibilities: - Assist in the preparation,assembly, and distribution of clinical trial documentation andreports. - Manage and maintain the pTMF and eTMF system, ensuringtimely submission and archival of documents, completeness, andaccuracy. Regularly conduct quality checks on the TMF system. -Accountable for the organization of Compassionate Use documentationand pre-clinical study reports library. - Assist clinical trialteam with the organization, planning, and execution of clinicaltrials in accordance with standard operating procedures, goodclinical practice, and applicable regulatory requirements. - Liaisewith project managers, clinical operations, clinical quality staff,and other relevant team members to facilitate document collectionand retention. - Review study-related or essential documents forcompleteness and compliance with protocol and relevant regulations.- To train personnel on standards and TMF-related activity - Assistwith the resolution of any issues or queries that arise during theclinical trial. - Participate in regulatory and internal studyaudits, supporting the team in the preparation and follow-upactivities. Required Skills and Qualifications: - Bachelor''s degreein life sciences, healthcare, or a related field. - Previousexperience in a similar role, preferably within a pharmaceutical orbiotech environment, desired but not essential. - Knowledge ofclinical research processes, regulatory requirements, and goodclinical practice (GCP). - Familiarity with eTMF systems and otherclinical trial management systems, desirable. - Excellentorganizational skills and attention to detail. - Good communicationskills, both written and verbal. - Ability to work in a fast-pacedenvironment and manage multiple priorities. - Proficiency in MSOffice (Word, Excel, PowerPoint). Job Location Siena