Clinical Project Manager

2 settimane fa

Milano, Italia IQVIA A tempo pieno

On behalf of our Client a global pharmaceutical company, IQVIA is looking for a **Clinical Project Manager for Early phase study **who can join an exciting working environment in a dynamic atmosphere.

**RESPONSIBILITIES**:
He/she is responsible for the management of the **early phase clinical studies** (from First in Human studies to Proof Of Concept 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 the Company Study team and constitutes the reference point both at company level and for the CROs involved in the execution of the Study.

**BRIEF DESCRIPTION OF THE ACTIVITIES**:

- 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.

**REQUIREMENTS**:

- Degree in Life Sciences (biological science, pharmacy or other health related discipline) or equivalent.
- At least 4 years of experience in a similar position in a pharmaceutical company or CRO.
- Knowledge of principles of clinical study design
- Experience in translational medicine trials with collection of specimens like sputum and blood for biomarkers analysis
- 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)

**TYPE OF CONTRACT**:
Permanent contract

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