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Real World Evidence Study Manager

3 mesi fa

Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

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Real World Evidence Study Manager - Temporary Date:  3 May 2024
Department:  Global Clinical Development
Team:  R&D, Pharmacovigilance & Regulatory Affairs
Job Type:  Direct Employee
Contract Type:  Temporary
Location:  Parma, IT

About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.
We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.
In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. 
Chiesi Research & Development Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, chemical manufacturing and controls, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden) and Toronto (Canada).
Who we are looking for PurposeAs 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 ResponsibilitiesStrategy
• 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 RequiredAt least 3 years of experience in biopharmaceutical industry in Clinical Operations roles. 
EducationMSc degree in scientific disciplines (Biology, Biotechnology, Chemistry, Pharmacy, Chemical and Pharmaceutical Technology) and a high proficiency in spoken and written English
LanguagesTechnical SkillsExperienced 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 SkillsPlanning and organizational skills What 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, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being. We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
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