Clinical Trial Documentation

Select how often (in days) to receive an alert: Clinical Trial Documentation & Records Management Lead Department: Global Clinical Development Business Area: R&D, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT About us Based 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 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, 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 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 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 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 e TMF Manager as defined by Veeva standards. Clinical trial technologies Ownership & Oversight Oversee 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 needed Process & Compliance Author 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 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 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 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. The role is pivotal in mitigating risks of inefficiency, non-compliance, and compromised inspection readiness. You will need to have Bachelor'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. e TMF 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 have Excellent 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 e TMF/CTMS systems and industry best practices. Location Preferably based in Italy, with flexible hybrid working arrangements. 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. DISCOVER ALL OUR JOB OPPORTUNITIES Screen readers cannot read the following searchable map. #J-18808-Ljbffr