Real World Evidence Study Manager - Temporary Parma

Real World Evidence Study Manager - Temporary
Parma
Emilia Romagna, Parma

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Real World Evidence Study Manager - Temporary, ParmaClient: Chiesi Group

Location: Parma

Job Category: Other

EU work permit required: Yes

Job Reference: 83f91bd365c7

Job Views: 9

Posted: 19. 02. 2025

Expiry Date: 05. 04. 2025

Job Description:Who we are looking forPurposeAs a member of the RWE unit, the RWE Study Manager supports the fostering of the RWE mindset by managing and coordinating RWE studies, under the RWE Program Leader oversight, on secondary data collection for the different phases of the product life cycle across multiple geographies by:

Providing technical-scientific support within the process of drafting, revising, and implementing RWE study designs and research protocols of RWE studies on secondary data collection;Managing and coordinating cross-functional teams involved in RWE initiatives and projects, ensuring adherence to specific timelines and budget;Preparing documents for submission to Ethics Committees and Regulatory Authorities as applicable;Overseeing electronic TMF set-up and maintenance during the study and ensuring documentation completeness;Participating in regular meetings with RWE study teams and CROs to monitor performance. Main ResponsibilitiesStrategy: Supports the strategy definition and implementation of RWE studies based on secondary data analysis, contributing to the achievement of Chiesi's strategic goals and medical/scientific standards.

Global Studies: Coordinates the RWE study teams in the selection, verification, and supervision of CROs and other providers, overseeing the management of RWE secondary data collection studies.

Processes and Tools: Supports the implementation and adaptation of procedures within RWE studies to fulfill regulatory requirements and company strategic goals.

Experience RequiredAt least 3 years of experience in the biopharmaceutical industry in Clinical Operations roles.

EducationMSc degree in scientific disciplines (Biology, Biotechnology, Chemistry, Pharmacy, Chemical and Pharmaceutical Technology) and high proficiency in spoken and written English.

Technical SkillsExperienced in principles of clinical study design, planning tools, and ICH/GCP guidelines.

Knowledge of budget planning and administrative management, including SAP tool knowledge.

Soft SkillsPlanning and organizational skillsWhat we offer You would join a dynamic, fast-growing, challenging, and friendly environment.

In Chiesi, we believe that our people are our most valuable asset, which is why we invest in continuous training, learning, and development.

We strive to promote and satisfy development needs while paying attention to the quality of our working environment and collective well-being.

We want our people to come to work happy every day.

To support this, we offer a flexible working approach, remote working options, relocation support, tax assistance for foreign colleagues, and many other people-care services.

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