Clinical Trial Documentation

10 ore fa

Parma, Italia Chiesi Group A tempo pieno

Who we are looking for This is what you will do The 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 eTMF 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 eTMF & CTMS, incl. Insp Readiness eTMF. 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 for Leadership & 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, set up 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 the eTMF/CTMS user accounts, training, management, systems troubleshooting and new releases adoption. Coordinate and ensure adequate and proactive monitoring of eTMF/CTMS metrics and KPIs, escalating issues to Study Teams or Clinical Partnership as needed. Ensure overall inspection readiness, including training,

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