Clinical Trial Administrator

Clinical Trial Administrator - Maternity leave Date : 29 Oct 2025Department : GRD Clinical DevelopmentBusiness Area : R&D, Pharmacovigilance & Regulatory AffairsJob Type : Direct EmployeeContract Type : TemporaryLocation : Flexible, 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 hereWe are proud to have been awarded with B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behaviour 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 behaviours. 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 behaviours.We are committed to embrace diversity, inclusion and equal opportunities. 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 Global Rare DiseasesChiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialisation of treatments and patient support services for rare and ultra‑rare disorders, many of whom have limited or no treatments available.This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma.Rare unit has a focus on research and product development for lysosomal storage diseases, rare haematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. Discover more here .What we are looking forPurpose To manage the administrative and documentation aspects of clinical trials at every stage of the process (study documentation, maintaining databases, creating / updating trackers and support with supplies management)Main ResponsibilitiesSupport the CPM in preparation of study TMF Plan and Map, and other Clinical Study Plans as requiredMaintain paper / electronic TMF and electronic internal repositories according to applicable guidelines, regulations and proceduresPerform TMF periodic quality checks and reconciliation after study completionSupport the CPM in the activities to maintain the TMF Inspection ReadyParticipate in the TMF specific training as requiredParticipate in the completion of the RFPs in collaboration with the CPMsPrepare / assemble study documentation (e.g. study documents managed through EDMS) and supports the CPM in ensuring the compliance of the clinical trial with internal SOPs and applicable regulationsPrepare and maintain all trackers required for the study conductPrepare and ship the ISFs to the investigational sites as requiredSupport the study team during internal audit and inspectionsSupport the CPM in managing the EDMS processesSupport the CPM in managing the insurance request for a Clinical TrialInteract with external providers during study conduct as requiredParticipate in study specific meetings, e.g., KOM, IM, update meetings with the CROs / CSPs, and other meetings as requiredCollaborate with CPM, CS Unit and QA in order to manage activities related to clinical trial supplies, for example prepares the CTS Request Form for validation by the CPMManage the study Inbox EmailAssist the eCTD team in the formatting of all documentation related to a clinical study, as requiredSupport with invoices verification and all the administrative trackers received from the CROs / CSPsSupport in management of study related#J-18808-Ljbffr