Real World Evidence Study Manager - Temporary Parma

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

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

Location:Job Category:Other

EU work permit required:Yes

Job Reference:83f91bd365c7

Job Views:3

Posted:22. 01. 2025

Expiry Date:08. 03. 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 oversight of the RWE Program Leader, focusing on secondary data collection for 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;Managing and coordinating cross-functional teams involved in RWE initiatives, ensuring adherence to timelines and budgets;Preparing documents for submission to Ethics Committees and Regulatory Authorities;Overseeing electronic TMF set-up and maintenance during the study, ensuring documentation completeness;Participating in meetings with RWE study teams and CROs to monitor contracted activities. Main ResponsibilitiesStrategy

Support the strategy definition and implementation of RWE studies based on secondary data analysis;Consolidate communication strategies involving all relevant stakeholders on the progress of RWE projects. Global Studies

Coordinate RWE study teams in the selection and supervision of CROs and providers;Oversee management of RWE secondary data collection studies;Contribute to relevant RWE publications when needed;Check monthly costs invoiced to Chiesi based on planned vs actual study activities. Processes and Tools

Support the implementation of procedures within RWE studies to fulfill regulatory requirements. 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 SkillsExperience in clinical study design and planning tools;Knowledge of ICH/GCP and company SOPs;Familiarity with budget planning and administrative management, specifically with SAP;Experience in documental archiving and management. Soft SkillsPlanning and organizational skillsWhat we offer You would join a dynamic, fast-growing, challenging, and friendly environment.

In Chiesi, we firmly believe that our people are our most valuable asset, which is why we invest in continuous training 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, and we know the importance of finding the right work-life balance.

We offer a flexible working approach, remote working, support in the relocation process, tax assistance for foreign colleagues, and many other people-care services.

Please note that if you are NOT a passport holder of the country for the vacancy, you might need a work permit.

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