Lavori attuali relativi a Clinical trial documentation - Rome - Chiesi Group
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Hybrid Lead: Clinical Trial Documentation
3 giorni fa
Rome, Italia Chiesi Farmaceutici S.P.A. A tempo pienoA leading pharmaceutical company is seeking a Clinical Trial Documentation & Records Management Lead in Parma, Italy. This role involves establishing and improving the documentation unit, ensuring compliance with regulatory standards. Ideal candidates will have 8-10 years of clinical operations experience, strong leadership skills, and knowledge of eTMF and...
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Head Of Clinical Trial Documentation
8 ore fa
Rome, Italia Chiesi Farmaceutici S.P.A. A tempo pienoA leading pharmaceutical company is seeking a Clinical Trial Documentation & Records Management Lead in Parma, Italy. This role involves establishing and improving the documentation unit, ensuring compliance with regulatory standards. Ideal candidates will have 8-10 years of clinical operations experience, strong leadership skills, and knowledge of e TMF and...
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Head of Clinical Trial Documentation
3 giorni fa
Rome, Italia Chiesi Farmaceutici S.P.A. A tempo pienoA leading pharmaceutical company is seeking a Clinical Trial Documentation & Records Management Lead in Parma, Italy. This role involves establishing and improving the documentation unit, ensuring compliance with regulatory standards. Ideal candidates will have 8-10 years of clinical operations experience, strong leadership skills, and knowledge of eTMF and...
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Senior Clinical Research Associate
3 giorni fa
Rome, Italia Advanced Clinical A tempo pienoSenior Clinical Research Associate (Oncology)Working embedded with a leading global oncology-focused biopharmaceutical companyWe are partnering with a top-tier global biopharmaceutical organisation to support a growing oncology portfolio and are seeking an experienced Clinical Research Associate to join the team in an advanced, hands-on clinical role.This...
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Global Clinical Trial Ops
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Rome, Italia Planet Pharma A tempo pienoClinical Trial Associate (CTA)A leading pharmaceutical company is seeking a Clinical Trial Associate (CTA) in Turbigo, Italy. In this vital role, you will support the global clinical team, ensuring quality systems and documentation compliance. Ideal candidates should have a Bachelor's degree in a related field, be fluent in English and Italian. Experience in...
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Senior Clinical Research Associate
2 settimane fa
Rome, Italia Advanced Clinical A tempo pienoSenior Clinical Research Associate (Oncology) Working embedded with a leading global oncology-focused biopharmaceutical company We are partnering with a top-tier global biopharmaceutical organisation to support a growing oncology portfolio and are seeking an experienced Clinical Research Associate to join the team in an advanced, hands‑on clinical role....
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Senior Clinical Research Associate
1 settimana fa
Rome, Italia Advanced Clinical A tempo pienoSenior Clinical Research Associate (Oncology)Working embedded with a leading global oncology-focused biopharmaceutical companyWe are partnering with a top-tier global biopharmaceutical organisation to support a growing oncology portfolio and are seeking an experienced Clinical Research Associate to join the team in an advanced, hands‑on clinical role.This...
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Senior clinical research associate
1 settimana fa
Rome, Italia Advanced Clinical A tempo pienoSenior Clinical Research Associate (Oncology)Working embedded with a leading global oncology-focused biopharmaceutical companyWe are partnering with a top-tier global biopharmaceutical organisation to support a growing oncology portfolio and are seeking an experienced Clinical Research Associate to join the team in an advanced, hands-on clinical role.This...
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Global Clinical Trial Ops
1 settimana fa
Rome, Italia Planet Pharma A tempo pienoA leading pharmaceutical company is seeking a Clinical Trial Associate (CTA) in Turbigo, Italy, to provide operational support to the global clinical team. The role is vital in maintaining quality systems and documentation compliance. Ideal candidates will have a Bachelor's degree in a related field and be fluent in both English and Italian. Experience in...
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Global Clinical Trial Ops
3 giorni fa
Rome, Italia Planet Pharma A tempo pienoA leading pharmaceutical company is seeking a Clinical Trial Associate (CTA) in Turbigo, Italy. In this role, you will support the global clinical team by ensuring quality systems and documentation compliance. The ideal candidate possesses a Bachelor's degree in a relevant field and is fluent in English and Italian. Experience in clinical research and...
Clinical trial documentation
5 giorni fa
Clinical Trial Documentation & Records Management LeadJoin to apply for the Clinical Trial Documentation & Records Management Lead role at Chiesi GroupBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with 90 years' experience, operating in 31 countries with more than 7,000 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 hereWe 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 & DevelopmentOur 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, global technical development, 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), Toronto (Canada) and Shanghai (China).Who we are looking forThis is what you will doThe Clinical Trial Documentation & Records Management Lead is responsible for establishing, leading, and continuously improving the Clinical Trial Documentation & Records Management Unit within Chiesi GCD. This role ensures alignment between organizational and technical requirements for clinical trial documentation and records, driving the adoption and maintenance of clinical trial technologies, including relevant processes and procedures. The Clinical Trial Documentation & Records Management Lead drives compliance with both regulatory and business/technology (e.g. Veeva) standards and guarantees inspection readiness across the R&D Clinical trial technology ecosystem, with a focus on e TMF and CTMS modules, as well as any additional clinical modules implemented or adopted.In addition, the Clinical Trial Documentation & Records Management Lead provides line management to the reporting roles (e.g. Clinical Trial Documentation & Records Management Specialists) and coordinate operations within GCD and others Chiesi functions (e.g. CTS, PV) for what concerns e TMF & CTMS, incl. Insp Readiness e TMF.Additionally, the Lead plays a key role in managing strategic vendors for clinical trial technology (e.g., Veeva), overseeing contractual, business, and technical aspects, and may liaise with CROs as needed.You will be responsible forLeadership & Team CoordinationLead the Clinical Trial Documentation & Records Management Unit, overseeing direct reports (e.g. Clinical Documentation & Records Specialists) performance and development.Coordinate operations with other GCD/other R&D functions, such as Clinical Trial Supply (CTS), Pharmacovigilance (PV), Quality Assurance (QA), Clinical Operations Excellence, GCD Compliance, Study Teams.May serve as Clinical Business Administrator and e TMF Manager as defined by Veeva standards.Clinical trial technologies Ownership & OversightOversee the adoption, set up and maintenance of clinical trial technologies, such as e TMF/CTMS instances, in collaboration with cross-functional Study Teams, other GCD/R&D functions and GICT.Supervise the e TMF/CTMS user accounts, training, management, systems troubleshooting and new releases adoption.Coordinate and ensure adequate and proactive monitoring of e TMF/CTMS metrics and KPIs, escalating issues to Study Teams or Clinical Partnership as needed.Ensure overall inspection readiness, including training, account setup, audit trail maintenance, and co-development of storyboards for audits and inspections.Manage strategic vendors for clinical trial technology (e.g., Veeva), overseeing budget, contractual, business, and technical aspects, and may liaise with CROs as neededProcess & ComplianceAuthor and update Clinical trial technologies (e.g. e TMF/CTMS) related SOPs and Working Instructions in collaboration with other functions such as GCD Clinical Compliance Unit, Clinical Operations Excellence and QA.Plan and coordinate periodic BIMO checklist reviews with Study Teams and CROs, especially for GCD pivotal trials.Oversee and/or establish mechanisms for the upload and management of Chiesi documents generated internally or externally into e TMF or other repositories.Drive business transformation, digitalization, and continuous improvement across people, processes, and technology.Ensure the unit's readiness for e TMF deployment and integration with CTMS and other R&D Veeva modules and/or other Clinical trial technologies.Address/ensure appropriate mechanisms are in place to address organizational and technical needs during system deployment and operational phases.People & Performance ManagementManage a multi-functional team.Set clear goals, KPIs, and development plans for direct reports.Promote a culture of accountability, collaboration, and continuous learning.Cross-functional CollaborationCollaborate with different stakeholders, internal and external, to ensure seamless execution of the tasks managed by the unit.Share best practices and drive synergies across GCO and GCD.Impact & Strategic ImportanceThe leadership of this unit is critical for the success of Clinical trial technologies adoption, integration and utilization to enhance studies oversight and internal alignment.The role is pivotal in mitigating risks of inefficiency, non-compliance, and compromised inspection readiness.
