Regional Clinical Trial Management Associate

ppBeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. /p h3General Description /h3 ul liSupports the Regional Clinical Study Manager in regional study delivery and ensures that delegated components of clinical studies are executed per expected and specified quality standards, within timelines and budget /li liBuilds solid knowledge of clinical trials operations in the region under guidance of the Regional Clinical Study Manager /li liSupports the alignment of regional deliverables with overall study goals under the direction of the Regional Clinical Study Manager /li /ul h3Essential Functions Of The Job /h3 h3Regional Trial Support Collaboration /h3 ul liDevelops regional study management experience by supporting to oversee multiple aspects of clinical trial conduct including feasibility assessment, study start-up, document generation and review, tracking of samples and enrollment of study participants. /li liAcquires solid knowledge of clinical research operations, including interpretation and implementation of regulations/ICH guidelines /li liSupports the Regional Clinical Study Manager with set up and logistics of regional team meetings (agenda, minutes, ..) /li liEstablishes good collaboration with Regional Clinical Study Manager, the Global Study Management Associate and other key stakeholders regionally and globally /li liAs required, supports CRAs with various activities such as monitoring visit preparations, TMF filing, .. /li /ul h3Timelines, Planning and Execution /h3 ul liCreates and maintains regional/country level SharePoint folders for the study and regional study team distribution lists /li liSets up the countries and sites in the region in the appropriate systems e.g. eTMF, CTMS, ..and makes sure information is kept up to date /li liSupports system access requests for the region/country and ensure these are managed appropriately across the study life cycle, supports user account management for users in region /li liMight support the local adaptation of global documents under supervision of the Regional Clinical Study Manager /li liMay assist in the review of study-related documents as they relate to the supported clinical trials as delegated by the Regional Clinical Study Manager (e.g., Informed consent forms, regional Pharmacy Manual, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, CRF Completion Guidelines and other relevant regional study plans and charters) /li liSupports study start up in region/country in close collaboration with the regional study start up team and the Regional Clinical Study Manager /li liSupports the organization of study specific investigator meetings together with the Regional Clinical Study Manager and the Global Study Management Associate /li liSupports the TMF specialist with country/site level TMF creation and maintains the country/site level TMF including regular review and QC of TMF documents as per the study TMF QC plan /li liHelps resolving any regional/country specific issues related to clinical supplies in collaboration with relevant stakeholdersd /li liSupports the data cleaning activities and contributes to the follow up of outstanding information for region/country /li liPrepares site newsletters and other correspondence related to clinical trial conduct (eg, best practices and lessons learned, frequently asked questions) in collaboration with the study team /li liMight assist in resolution of routine study questions from clinical trial sites /li liMight support the maintenance of information for region/country in relevant public registries (e.g CT.gov) /li liSupports the Regional Clinical Study Manager with providing all relevant information from region/country to be included in the Clinical Study Report /li /ul h3Quality /h3 ul liSupports the identification of operational risks and works with the Regional Clinical Study Manager to recommend solutions for discussion with appropriate team leadership /li liLearns and shares best practices in clinical operations methodologies, systems and processes with the emphasis on quality and compliance /li liMight support the preparation of sites for quality assurance audits and inspections /li liSuggests improvements to enhance the efficiency and the quality of the work performed on assigned projects /li liMight support the development of local/regional tools, working instructions and SOPs /li /ul h3Budget /h3 ul liSupports set up of vendors for activities outsourced in region/country /li liSupports management of regional study budget incl PO set up /li liSupports PO set up for regional vendors /li /ul h3Education Required /h3 ul liBachelor’s Degree in a scientific or healthcare discipline required*, Higher Degree preferred /li liexceptions might be made for candidates with relevant clinical operations experience /li /ul h3Computer Skills /h3 pMS Office /p h3Other Qualifications /h3 ul liKnowledge of clinical operations methodologies, understanding of operational aspects of clinical study processes /li li1 or more years of experience in clinical research within biotech, pharma or CRO industry /li /ul h3Travel: /h3 pLimited travel might be require /p pSalary Range Italy: 37,000.00 EUR - 46,300.00 EUR /p h3Global Competencies /h3 pWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. /p ul liFosters Teamwork /li liProvides and Solicits Honest and Actionable Feedback /li liSelf-Awareness /li liActs Inclusively /li liDemonstrates Initiative /li liEntrepreneurial Mindset /li liContinuous Learning /li liEmbraces Change /li liResults-Oriented /li liAnalytical Thinking/Data Analysis /li liFinancial Excellence /li liCommunicates with Clarity /li /ul pWe are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. /p /p #J-18808-Ljbffr