Real World Evidence Study Manager - TemporaryDate: 26 Oct 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. 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.
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.
Who we are looking for PurposeAs 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:
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.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.Responsible for electronic TMF set-up and maintenance during the study, oversight of filing documentation completeness, through ongoing quality checks and metrics.Participation in regular and periodic meetings with the RWE study teams and the CRO (or other providers) 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 contribute to the achievement of Chiesi strategic goals and medical/scientific standards.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.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 to 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.
Technical SkillsExperienced in 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 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, 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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