Real World Evidence Study Manager
4 settimane fa
Our client, **Chiesi Farmaceutici** **- one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry - in order to expand their staff, entrusted to IQVIA the recruitment of a **Real World Evidence (RWE) Study Manager** who can join an exciting working environment in a dynamic and international atmosphere.
**RESPONSIBILITIES**:
- Strategy_
- Supports the strategy definition and implementation of RWE studies based on secondary data analysis, and other RWE assigned projects, in order to contributes the achievement of Chiesi strategic goals and medical/scientific standards under RWE Program Leader guidance
- Actuate and consolidate the communication strategy involving all relevant stakeholders on the progress of the RWE projects cross-functionally in the Company
- Global Studies_
- Coordinates the RWE study teams in the selection, verification and supervision of the CRO and other providers (related to activation, management and performance monitoring), pursuant to the terms of the legislation GCP, GVP and other local legislation applicable.
- Oversights the management of the RWE secondary data collection studies/initiatives
- Contributes to relevant RWE publications in the area of competence when needed
- Checks monthly costs invoiced to Chiesi based on planned study activities vs actual.
- Processes and tools_
- Support the implementation and specific adaptation of procedures within RWE studies fulfil regulatory requirements and company strategic goals.
**REQUIREMENTS AND SKILLS**:
- Experienced in team management and propension for team work
- Experienced of principles of clinical study design, planning tools and planning principles
- Experience of ICH/GCP and company SOPs
- Knowledge of budget planning and administrative management with specific SAP tool knowledge
- Experienced in documental archiving and management
- Proficient written and spoken English
- Problem solving
- ime Management
- Quality Orientation
- Stress Management
- Planning & Organizing
- Project Management
- Responsiveness
- Team Working
- Conflict’ Management
**TYPE OF CONTRACT**:
Permanent contract
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