Real World Evidence Study Manager - Temporary

Purpose

As member of the RWE unit, the RWE Study Manager support 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:
•    Technical-scientific notional support within the process of draft, revision and implementation of RWE study designs, research protocols of RWE studies on secondary data collection and initiatives of which CHIESI is Sponsor, pursuant of the terms of the applicable legislation under the RWE Program Leader supervision;
•    Operational management and coordination of cross functional teams involved in RWE initiatives and projects on secondary data collection, ensuring the specific timelines and budget defined;
•    Support to the Study Teams and RWE unit, with the preparation of documents for submission to the Ethics Committees and Regulatory Authorities as applicable, pursuant to the terms of the applicable legislation for the RWE projects on secondary data collection; 
•    Responsible for electronic TMF set-up and maintenance during the study, oversight of filing documentation completeness, through ongoing quality checks and metrics, oversight of CRO, or other provider, filing activities in the eTMF and will be responsible for eTMF reconciliation after study completion;
•    Participation in regular and periodic meetings with the RWE study teams and the CRO (or other providers) to be carried out with Chiesi staff, in order to monitor the performance of the contracted activities.
 

Main 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.
 

Experience Required

At least 3 years of experience in biopharmaceutical industry in Clinical Operations roles. 

Education

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

Languages

English fluent 

Technical Skills

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.
 

Soft Skills