Requirements: English
Company: Philogen S.p.A.
Region: Siena , Tuscany
Philogen S.p.A. is a biotechnology company whose mission is the development of biologic products for the imaging and therapy of life-threatening diseases, with a strategic focus on cancer diseases and rheumathologic disorders.
We are currently seeking a highly organized, detail-oriented Clinical Trial Assistant to join our dynamic team. This individual will play an essential role in supporting our clinical trial operations and overseeing both the paper trial master file (pTMF) and the electronic trial master file (eTMF) system.
The position is reserved for candidates belonging to protected categories according to Law 68/99.
Responsibilities:
- Assist in the preparation, assembly, and distribution of clinical trial documentation and reports.
- Manage and maintain the pTMF and eTMF system, ensuring timely submission and archival of documents, completeness, and accuracy. Regularly conduct quality checks on the TMF system.
- Accountable for the organization of Compassionate Use documentation and pre-clinical study reports library.
- Assist clinical trial team with the organization, planning, and execution of clinical trials in accordance with standard operating procedures, good clinical practice, and applicable regulatory requirements.
- Liaise with project managers, clinical operations, clinical quality staff, and other relevant team members to facilitate document collection and retention.
- Review study-related or essential documents for completeness and compliance with protocol and relevant regulations.
- To train personnel on standards and TMF-related activity
- Assist with the resolution of any issues or queries that arise during the clinical trial.
- Participate in regulatory and internal study audits, supporting the team in the preparation and follow-up activities.
Required Skills and Qualifications:
- Bachelor''s degree in life sciences, healthcare, or a related field.
- Previous experience in a similar role, preferably within a pharmaceutical or biotech environment, desired but not essential.
- Knowledge of clinical research processes, regulatory requirements, and good clinical practice (GCP).
- Familiarity with eTMF systems and other clinical trial management systems, desirable.
- Excellent organizational skills and attention to detail.
- Good communication skills, both written and verbal.
- Ability to work in a fast-paced environment and manage multiple priorities.
- Proficiency in MS Office (Word, Excel, PowerPoint).
Job Location
Siena