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Trial Data Manager

Trial Data Manager

CTCBasel and NW Switzerland, CH
Vor 30+ Tagen
Stellenbeschreibung

Main Responsibilities :

  • Ensures that Data Management (Biometry) activities (related to assigned study) adhere to Company Standards, and applicable regulations
  • Meets study timelines in terms of Data Management deliverables
  • Ensures data handling consistency within allocated study(ies)
  • Leads Data Management activities for assigned study
  • Provides Data Management input to the development of the study protocol
  • Coordinates the development of the (e)CRF in line with Company standards
  • Writes 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 environment
  • Organizes, monitors and tracks data cleaning, data review, query management, and database lock. Makes sure processes are driven in collaboration with key Clinical Development (CD) stakeholders
  • Generates study metrics and status reports
  • Represents Data Management at Clinical Trial Team (CTT) meetings
  • Manages and is accountable for Data Management activities in studies where Data Management is outsourced (insourcing / outsourcing partners’ management)
  • Prepares and archives Data Management study documentation
  • Presents study related topics at CTT, Investigators and Monitors meetings
  • Participates in development and review of policies, Standard Operating Procedures (SOPs), and associated documents for Data Management
  • Represents Data Management in cross functional working groups related to the system / process
  • Forecasts study team resource requirements
  • Ensures Data Managers assigned to study have required training
  • Ensures Study Data Tabulation Model (SDTM) deliverables (Including SDTM datasets, define.xml and annotated CRF) are created, validated and provided as per agreed timelines
  • Performs 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 GCP
  • Work is expected to be performed on the premises of Company
  • Acts as Data Manager for studies where no DM is assigned

Qualifications and Experience :

  • Relevant Swiss working / residency permit and / or Swiss / EU-Citizenship required;
  • Recognized degree in life sciences, mathematics, statistics, informatics or related disciplines
  • At 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 Management
  • Good 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) design
  • Ability to lead and coordinate the activity of Data Manager(s) allocated to his / her study
  • Good organizational and presentation skills
  • Fluent in written and spoken English