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Clinical Trial Documentation
3 giorni fa
Clinical Trial Documentation & Records Management LeadSelect how often (in days) to receive an alert :Department : Global Clinical DevelopmentBusiness Area : R&D, Pharmacovigilance & Regulatory AffairsJob Type : Direct EmployeeContract Type : PermanentLocation : Parma, ITAbout usBased 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 Lead drives compliance with regulatory and business/technology (e.g. Veeva) standards and guarantees inspection readiness across the R&D Clinical trial technology ecosystem, focusing on eTMF and CTMS modules, as well as any additional clinical modules implemented or adopted.Provide line management to reporting roles (e.g. Clinical Trial Documentation & Records Specialists) and coordinate operations within GCD and other Chiesi functions (e.g. CTS, PV) for eTMF & CTMS, including Insp Readiness eTMF.Manage strategic vendors for clinical trial technology (e.g. Veeva), overseeing contractual, business, and technical aspects, and liaising with CROs as needed.You will be responsible forLeadership & Team Coordination — Lead 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 eTMF Manager as defined by Veeva standards.Clinical trial technologies Ownership & Oversight — Oversee the adoption, setup and maintenance of clinical trial technologies, such as eTMF / CTMS instances, in collaboration with cross-functional Study Teams, other GCD / R&D functions and GICT. Supervise user accounts, training, systems troubleshooting and new releases adoption. Monitor eTMF / CTMS metrics and KPIs, escalating issues as needed. Ensure 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 needed.Process & Compliance — Author and update Clinical trial technologies (e.g. eTMF / CTMS) related SOPs and Working Instructions in collaboration with 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 eTMF or other repositories. Drive business transformation, digitalization, and continuous improvement across people, processes, and technology. Ensure readiness for eTMF deployment and integration with CTMS and other R&D Veeva modules and/or other Clinical trial technologies. Address/ensure mechanisms are in place to address organizational and technical needs during system deployment and operation.People & Performance Management — Manage 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 Collaboration — Collaborate with stakeholders, internal and external, to ensure seamless execution of unit tasks. Share best practices and drive synergies across GCO and GCD.Impact & Strategic Importance — The leadership of this unit is critical for the success of Clinical trial technologies adoption, integration and utilization to enhance studies oversight and internal alignment. This role mitigates risks of inefficiency, non-compliance, and compromised inspection readiness.You will need to haveBachelor's degree or equivalent in appropriate scientific or business disciplines, familiar with relevant ICH / GCP, EU and FDA guidelines and SOPs. 8-10 years of experience in clinical operations, and specifically with the adoption and management of Clinical trial technologies (e.g. eTMF and CTMS) and associated processes. Proven track record in managing cross-functional teams, with at least 5 years of experience.We would prefer for you to haveExcellent knowledge of healthcare compliance and other relevant guidance. Knowledge of regulatory requirements, inspection readiness, and SOP development / authoring. Excellent knowledge of the clinical trials settings.Excellent project management capabilities with demonstrated capability to problem solve and mediate complex issues.Understands financial procedures, budget management.Experience in clinical trial documentation, records management, or related areas.Familiarity with Veeva eTMF / CTMS systems and industry best practices.LocationPreferably based in Italy, with flexible hybrid working arrangements.What we offerYou 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.J-18808-Ljbffr#J-18808-Ljbffr
