Who we are looking forPurpose- Accountable for coordination of the operational management of assigned projects in order to develop compounds in line with Chiesi goals and medical/scientific standards.- Accountable for communication to all stakeholders on the progress of the study- Accountable to maintain and respect budget according to study signed contractMain Responsibilities- Makes operational decisions to ensure that projects are initiated and completed on time, on budget and to the required quality standards, secures compliance with ICH and Chiesi Standard Operating Procedures (SOPs) or any local regulations.- Can be involved in the writing/review of SOPs and working instructions (WI). Completes assigned SOPs/WIs/processes trainings according to company process.- Project Management:Develops full synopsis and protocol, and related documents based on the Study Outline contained in the Clinical Development Plan (CDP) involving all relevant contributors persons. Collaborates with relevant contributors and accountable team members to ensure timely production and review of other important study-related. Contributes to the CRO and/or Providers selection: responsible for the implementation of the Request For Proposal (RFP); reviews and assess the proposals; reviews scope of works and overall budget.Responsible for management of the Clinical CRO/Providers Acting as primary contact for Clinical (CRO) but also internal customers. Ensures adherence to scope of work within timelines and budget. Performs co-monitoring when needed, as specified in SOP and collaborates with Site Engagement Managers for study site performance and relationship consolidation .Collaborates in the set-up and maintenance of the Study Risk Register. Responsible for ongoing clinical risk review during study conduct involving all relevant study team functions and for the follow-up on actions with vendors (CRO, direct and third-party vendors).Prepares and coordinates/collaborates to scientific meetings: investigators' meeting, scientific/safety board meetings, Data reviews and any other study-relevant meeting(s). Ensures registration of the study in public registries (e.g: clinicaltrial.gov, European registry, etc…).- Clinical Trial Supplies: liaises with Clinical Trial Supply (CTS) coordinator to define the CTS strategy/plan Reviews the labels and leaflets. - Responsible for the management of the study eTMF (related to clinical operations) and all its related activities (such as QC and health checks) with the Clinical Trial Administrator (CTA) as per Chiesi SOP. Accountable for the overall completeness of the whole study eTMF and for ensuring that the study eTMF is archived as per Chiesi SOP.- Study Budget: accountable for budget management and reconciliation as well as control of invoices on monthly basis. Twice a year provides forecast & preclosing budgets according to study progress. - Study results and related deliverables: Prepares the Clinical Study Report (CSR) in cooperation with the Medical Writer, reviews the CSR/CIR, coordinates its review/approval by required members. Reviews the layman summaries and study summaries for authorities.Supports and/or coordinates the presentation of clinical study results internally and externally as well as the preparation of manuscripts for the full paper publication.Experience RequiredAt least 5 years of experience in a similar position in a pharmaceutical company or CRO.Track record of achievements in successful planning and execution of at least 5 clinical studies.Added value will be given for direct experience in implementation of centralized systems set up and large clinical trial experience in respiratory therapeutic areaEducationDegree in Life Sciences or equivalent.LanguagesEnglish fluentTechnical SkillsProfessional skills needed to hold the positionSoft SkillsProblem solvingLeadership and social influenceQuality orientationTeam workingDecision makingWhat 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.
