Clinical Trial Documentation & Records Management Lead

ph3Clinical Trial Documentation Records Management Lead /h3 pJoin to apply for the bClinical Trial Documentation Records Management Lead /b role at bChiesi Group /b /p pBased 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: bDiscover more here /b /p pWe are proud to be the largest global pharmaceutical group to be awarded bB Corp Certification /b, a recognition of bhigh social and environmental standards /b. We are a breliable /b company that adopts and promotes a btransparent and ethical behavior /b at all levels. /p pWe believe that the success of bChiesi is built and shaped by our people and our strong set of shared Values and Behaviors /b. 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. /p pIn fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. /p pbChiesi Research Development /b /p pOur RD 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, RD 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). /p h3Who we are looking for /h3 h3This is what you will do /h3 pThe 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 RD Clinical trial technology ecosystem, with a focus on eTMF and CTMS modules, as well as any additional clinical modules implemented or adopted. /p pIn 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. /p pAdditionally, 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. /p h3You will be responsible for /h3 h3Leadership Team Coordination /h3 ul liLead the Clinical Trial Documentation Records Management Unit, overseeing direct reports (e.g. Clinical Documentation Records Specialists) performance and development. /li liCoordinate operations with other GCD/other RD functions, such as Clinical Trial Supply (CTS), Pharmacovigilance (PV), Quality Assurance (QA), Clinical Operations Excellence, GCD Compliance, Study Teams. /li liMay serve as Clinical Business Administrator and eTMF Manager as defined by Veeva standards. /li /ul h3Clinical trial technologies Ownership Oversight /h3 ul liOversee the adoption, set up and maintenance of clinical trial technologies, such as eTMF/CTMS instances, in collaboration with cross-functional Study Teams, other GCD/RD functions and GICT. /li liSupervise the eTMF/CTMS user accounts, training, management, systems troubleshooting and new releases adoption. /li liCoordinate and ensure adequate and proactive monitoring of eTMF/CTMS metrics and KPIs, escalating issues to Study Teams or Clinical Partnership as needed. /li liEnsure overall inspection readiness, including training, account setup, audit trail maintenance, and co-development of storyboards for audits and inspections. /li liManage strategic vendors for clinical trial technology (e.g., Veeva), overseeing budget, contractual, business, and technical aspects, and may liaise with CROs as needed /li /ul h3Process Compliance /h3 ul liAuthor and update Clinical trial technologies (e.g. eTMF/CTMS) related SOPs and Working Instructions in collaboration with other functions such as GCD Clinical Compliance Unit, Clinical Operations Excellence and QA. /li liPlan and coordinate periodic BIMO checklist reviews with Study Teams and CROs, especially for GCD pivotal trials. /li liOversee and/or establish mechanisms for the upload and management of Chiesi documents generated internally or externally into eTMF or other repositories. /li liDrive business transformation, digitalization, and continuous improvement across people, processes, and technology. /li liEnsure the unit’s readiness for eTMF deployment and integration with CTMS and other RD Veeva modules and/or other Clinical trial technologies. /li liAddress/ensure appropriate mechanisms are in place to address organizational and technical needs during system deployment and operational phases. /li /ul h3People Performance Management /h3 ul liManage a multi-functional team. /li liSet clear goals, KPIs, and development plans for direct reports. /li liPromote a culture of accountability, collaboration, and continuous learning. /li /ul h3Cross-functional Collaboration /h3 ul liCollaborate with different stakeholders, internal and external, to ensure seamless execution of the tasks managed by the unit. /li liShare best practices and drive synergies across GCO and GCD. /li /ul h3Impact Strategic Importance /h3 ul liThe leadership of this unit is critical for the success of Clinical trial technologies adoption, integration and utilization to enhance studies oversight and internal alignment. /li liThe role is pivotal in mitigating risks of inefficiency, non-compliance, and compromised inspection readiness. /li /ul h3You will need to have /h3 pBachelor's degree or equivalent in appropriate scientific or business disciplines, familiar with relevant ICH/GCP, EU and FDA guidelines and SOPs. /p pBachelor’s degree in life sciences or related field; advanced degree preferred. /p p8-10 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. /p pProven track record in managing cross-functional teams, with at least 5 years of experience. /p h3We would prefer for you to have /h3 pExcellent knowledge of healthcare compliance and other relevant guidance. Knowledge of regulatory requirements, inspection readiness, and SOP development/authoring. /p pExcellent knowledge of the clinical trials settings. /p pExcellent project management capabilities with demonstrated capability to problem solve and mediate complex issues. /p pUnderstands financial procedures, budget management. /p pExperience in clinical trial documentation, records management, or related areas. /p pFamiliarity with Veeva eTMF/CTMS systems and industry best practices. /p h3Location /h3 pPreferably based in Italy, with flexible hybrid working arrangements. /p h3What we offer /h3 pYou would join a dynamic, fast-growing, challenging and friendly environment. /p pIn 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. /p pWe 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. /p h3Seniority level /h3 pMid-Senior level /p h3Employment type /h3 pFull-time /p h3Job function /h3 pResearch /p pPharmaceutical Manufacturing /p /p #J-18808-Ljbffr