Data Manager - Switzerland - Hybrid Working - 12 month contract - 1 FTE
RBW Consulting
Allschwil, Bâle-Campagne
Contrat
Temps-plein
Il y a 18 jours
RBW Consulting are partnering with a leading Biopharmaceutical organisation in their search for a Data Manager on a 12 month contract in Switzerland. This company discovers, develops, and commercializes medicines across a wide variety of therapeutic areas.This role will be a 12 month, 1 FTE contract and it will be hybrid working with 3 days office based in Allschwil and 2 days working from home. The hourly rate on offer is in the range CHF 61.01 - 69.49 DOE.Job RequirementsEnsures that Data Management (Biometry) activities (related to assigned study) adhere to company Standards, and applicable regulationsMeets study timelines in terms of Data Management deliverablesEnsures data handling consistency within allocated study(ies)Leads Data Management activities for assigned studyProvides Data Management input to the development of the study protocolCoordinates the development of the (e)CRF in line with company standardsWrites all study Data Management documents covering specifications for external data transfer, data cleanings and review tools that will be further provided to Data Management Programmer(s) for development for the allocated study(ies)Organizes, monitors and tracks the testing of data entry screens (eCRF layout), data cleaning / review tools, and their implementation in the production environmentOrganizes, monitors and tracks data cleaning, data review, query management, and database lock. Makes sure processes are driven in collaboration with key Clinical Development (CD) stakeholdersGenerates study metrics and status reportsRepresents Data Management at Clinical Trial Team (CTT) meetingsManages and is accountable for Data Management activities in studies where Data Management is outsourced (insourcing/outsourcing partners' management)Prepares and archives Data Management study documentationPresents study related topics at CTT, Investigators and Monitors meetingsParticipates in development and review of policies, Standard Operating Procedures (SOPs), and associated documents for Data ManagementRepresents Data Management in cross functional working groups related to the system/processForecasts study team resource requirementsEnsures Data Managers assigned to study have required trainingEnsures Study Data Tabulation Model (SDTM) deliverables (Including SDTM datasets, define.xml and annotated CRF) are created, validated and provided as per agreed timelinesPerforms and/or coordinates Quality Control (QC): Periodic operational checks to verify that clinical data are handles according to protocol, applicable Quality System (QS) documents and GCPActs as Data Manager for studies where no DM is assignedExperienceRecognized degree in life sciences, mathematics, statistics, informatics or related disciplinesAt least 3 years' experience in Pharmaceutical or Biotech industry within Clinical Research and / or Clinical Data Management with good level of functional expertise in Data ManagementGood knowledge of international clinical research regulations and requirements (e.g., International Conference on Harmonization - Good Clinical Practice (ICH/GCP)Experience in clinical trial databases and applications, clinical data flow, data review, and (e)Case Report Form (CRF) designAbility to lead and coordinate the activity of Data Manager(s) allocated to his/her studyGood organizational and presentation skillsFluent in written and spoken EnglishPlease apply here and Harry Henson will be in touch to discuss your application in more detail.
