Early Phase Clinical Project Manager

3 giorni fa

Lazio, Italia Labcorp A tempo pieno

**Job Overview**:
He/she is responsible for the management of the **early phase clinical studies** in all their phases and aspects, operating in accordance with the rules of good clinical practice (GCP) and with the company SOPs.
He/she holds a coordinating role for Labcorp client Study team and constitutes the reference point both at company level and for the CROs involved in the execution of the Study.
- Participates in the selection activities of the clinical centers / CROs that will perform clinical studies;
- Is the point of contact for relations with the CROs in charge of clinical studies and supervises the delegated activities;
- Manages the preparatory activities for the conduct of clinical studies;
- Participation in the development of the clinical protocols as well as of the various study-related documents and coordinates their review by the study teams;
- In collaboration with the CRO, coordinates the preparation of the documentation necessary to request authorization for the execution of clinical studies;
- Manages the Study Start-Up and Study Closure procedures;
- Participates in Co-Monitoring visits to clinical Centers / CROs;
- Is responsible for the certification of the costs of the studies.
**Education/Qualifications**:
Degree in Life Sciences (biological science, pharmacy or other health related discipline) or equivalent;
**TECHNICAL SKILLS**:
- Knowledge of principles of clinical study design
- Knowledge of planning tools and planning principles
- Knowledge of ICH/GCP and company SOPs
- Knowledge of GLP for bio analytical assays
- Knowledge of the Trial Master File
- Use of the MS Office package (Word, Excel, Power Point)
**Experience**:
Experience of at least 3 year in the role;

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